Evaluating structure and content of parent-implemented early logopaedic intervention models following the three stages of communicative development in children with cleft lip and/or palate: Systematic literature review with narrative synthesis.

BACKGROUND: The development of communication, speech and language follows three stages (development of the parent-child relationship, interactions and actual speech and language acquisition). Children born with cleft lip and/or palate are at increased risk of communicative problems while parents may be going through an emotionally difficult time. Early parent-implemented logopaedic intervention that supports both parents and child is important. Three systematic reviews have examined the effects of early speech and language interventions, but not their structure and content. AIMS: To investigate which early parent-implemented logopaedic interventions already exist for children with cleft lip and/or palate, and to evaluate their structure, content and time of onset against the three stages of communicative development. METHODS: Six databases (PubMed, Embase, Web of Science, APA PsycInfo, Cinahl and Scopus) were searched between inception and 31 March 2023 to identify published articles that reported early parent-implemented logopaedic interventions in children with cleft lip and/or palate, aged 0 to 3 years, clearly describing the strategies used to train parents. Two authors independently assessed the eligibility of the studies. Quality assessment was conducted using the Physiotherapy Evidence Database quality assessment tool, Single-Case Experimental Design tool and the National Institutes of Health pre-post-study tools. The structure and content of the interventions were analysed taking into account the needs and difficulties of both the parents and the child according to the three stages of communicative development. MAIN CONTRIBUTION: The systematic literature search identified four studies that met the inclusion criteria. Three of them had a Level of Evidence III and one study had a Level of Evidence IV. Strategies appropriate for Stage 1 of communicative development (parent-child relationship) are well represented in only one study, but the psychosocial needs of parents are currently not included in these programmes. However, research shows that parental emotional difficulties can adversely impact a child's communicative development. Strategies appropriate for Stage 2 (promoting social interactions) are better represented. However, strategies appropriate for Stage 3 (acquiring correct speech and language patterns) are most represented in all intervention programmes. CONCLUSIONS: Three out of four intervention programmes focus on Stage 3 (actual speech and language stimulation). Stage 1 is underrepresented and the psychosocial needs of parents are currently not included in existing intervention programmes. Further research is needed in close collaboration with psychologists to construct a comprehensive, longitudinal, developmentally appropriate intervention programme that equally represents the three stages of communicative development and considers the psychosocial needs of parents. WHAT THIS PAPER ADDS: What is already known on the subject Children with cleft lip and/or palate are at increased risk of speech and language problems from birth. Parents of these children often have emotional problems following their child's diagnosis. The effectiveness of early intervention to facilitate the child's speech and language development has already been proven. Early intervention is recommended for both parents and child, but little is known about early parent-implemented logopaedic interventions that also provide psychosocial support for parents. What this paper adds to existing knowledge This review has shown that existing early parent-implemented logopaedic interventions for children with cleft lip and/or palate focus mainly on facilitating responsive interactions and actual speech and language development (Stages 2 and 3 of communicative development). However, Stage 1, where the parent-child relationship develops, is currently not included, even though this stage is a prerequisite of subsequent stages. If parents are struggling with emotional problems (following their child's diagnosis) this can negatively impact their mental health, the parent-child relationship, attachment and their child's development. What are the potential or actual clinical implications of this work? A clinical implication of the findings in this review is that more attention should be paid to Stage 1 of communicative development in early parent-implemented logopaedic interventions. By working closely with the psychologist of the cleft (and craniofacial) team, any psychosocial needs of the parents can be included in the counselling. As a result, the parents and their child are seen and supported as a unit and the parent-child relationship can develop optimally.

Patient-reported outcome measures on mental health and psychosocial factors in patients with Brugada syndrome.

AIMS: Brugada syndrome (BrS) is a hereditary arrhythmic disease, associated with sudden cardiac death. To date, little is known about the psychosocial correlates and impacts associated with this disease. The aim of this study was to assess a set of patient-reported psychosocial outcomes, to better profile these patients, and to propose a tailored psychosocial care. METHODS AND RESULTS: Patients were recruited at the European reference Centre for BrS at Universitair Ziekenhuis Brussel, Belgium. Recruitment was undertaken in two phases: phase 1 (retrospective), patients with confirmed BrS, and phase 2 (prospective), patients referred for ajmaline testing who had an either positive or negative diagnosis. BrS patients were compared to controls from the general population. Two hundred and nine questionnaires were analysed (144 retrospective and 65 prospective). Collected patient-reported outcomes were on mental health (12 item General Health Questionnaire; GHQ-12), social support (Oslo Social Support Scale), health-related quality of life, presence of Type-D personality (Type-D Scale; DS14), coping styles (Brief-COPE), and personality dimensions (Ten Item Personality Inventory). Results showed higher mental distress (GHQ-12) in BrS patients (2.53 ± 3.03) than in the general population (P < 0.001) and higher prevalence (32.7%) of Type D personality (P < 0.001) in patients with confirmed Brugada syndrome (BrS +). A strong correlation was found in the BrS + group (0.611, P < 0.001) between DS14 negative affectivity subscale and mental distress (GHQ-12). CONCLUSION: Mental distress and type D personality are significantly more common in BrS patients compared to the general population. This clearly illustrates the necessity to include mental health screening and care as standard for BrS.

Threat through the Screen? Association between Proximity and/or Watching Media Coverage of a Terrorist Attack and Health.

INTRODUCTION: After terrorist attacks, media coverage of the attacks is extensive. There are some indications that there is an association between watching the media coverage and certain health reactions, both mental and somatic. Most studies occur in the United States and often months after the initial attack. In the current study, we investigated the terrorist attacks in Belgium on 22 March 2016. METHODS: An online cross-sectional survey was conducted one week after the attacks among the general population of Belgium. We measured hours of media watching of the terrorist attacks (hereafter media watching), adjusted scales of the Patient Health Questionaire-4 (PHQ-4) to measure mental symptoms and the Patient Health Questionaire-15 (PHQ-15) to measure somatic symptoms, proximity to Brussels (home, work and overall proximity) and background factors such as gender, age and level of education. Respondents were included if they answered the survey between 29 March 2016 and 5 April 2016. RESULTS: A total of 2972 respondents were included. Overall, media watching was significantly associated with both mental symptoms (p < 0.001) and somatic symptoms (p < 0.001), while controlling for age, gender, level of education and proximity. Watching more than three hours of media was associated with more mental and somatic symptoms (p < 0.001). Compared to proximity, media watching was, in general, a better association. For geographical factors, watching more than three hours of media indicated equally high scores for mental symptoms and somatic symptoms as work proximity (p = 0.015) and overall proximity to the attacks (p = 0.024). CONCLUSION: Media-watching is associated with acute health reactions after terrorist attacks. However, the direction of the relationship is unclear, as it might also be that people with health issues seek out more media.

Aggression in mental health care: Opportunities for the future-A qualitative study on the challenges when defining and managing aggression across inpatient disciplines.

WHAT IS KNOWN ON THE SUBJECT?: Aggression towards caregivers is a global phenomenon in mental health care. Although attempts have been made to define aggression, there is no globally accepted definition. Discrepancies in defining aggression can lead to differences in judgement and a sub-par management of aggression. The fact that different disciplines work together in mental health care makes it an even more pressing matter as no research was found regarding a multidisciplinary definition of aggression. Currently, coercive measures, such as isolation, sedation or restraints, are the most common ways of managing aggression. WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE?: Mental healthcare nurses and psychologists defined aggression by previous experiences, and they also agree that there are no alternatives in managing aggression when non-coercive techniques do not work. Several opportunities and examples of best practice were given by the participants, but the consensus was that caregivers are in need of alternatives when they are face to face with acute aggression. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: It is vital for residential units to agree on a definition of aggression and acute aggression. It is our belief that this can aid them in preventing and de-escalating aggression as well as diminishing the use of coercive measures. Further primary research exploring the opportunities of non-coercive techniques, a multidisciplinary approach and the relationship between a workplace culture normalizing aggression and the mental well-being of healthcare workers is also needed. ABSTRACT: INTRODUCTION: Aggression by patients against healthcare workers is a global recurring phenomenon in mental health care. Discrepancies in defining aggression can lead to differences in judgement, which in turn causes difficulties in managing aggression. The multidisciplinary nature of mental healthcare makes a standardized definition an even more pressing matter. No studies, however, were found exploring the way different disciplines approach the definition of aggression. Although traditional methods of managing aggression rely on coercive methods, current research favours the use of non-coercive measures. AIM: The aim of this study was to explore the different ways mental healthcare nurses and psychologists define and manage aggression in a residential unit. METHOD: A qualitative research design was used, consisting of interviews and focus groups. Transcripts were analysed using a reflexive thematic approach. RESULTS: Three major themes were found: (1) approaches towards defining aggression, (2) experiencing aggression and (3) managing aggression: the need for alternatives. DISCUSSION: In this study, aggression is defined by how aggression has been experienced, both mental health nurses and psychologists agree that there are no alternatives in managing aggression when non-coercive techniques do not work. Aggression is considered an integral part of the job indicating an "aggression-tolerating" workplace. IMPLICATIONS FOR PRACTICE: Three implications for practice were identified: (1) It is vital for residential units to agree on a broad-based definition of aggression, (2) further primary research exploring the opportunities of non-coercive techniques and a multidisciplinary approach is crucial and (3) the relationship between a workplace culture normalizing aggression and the mental well-being of healthcare workers also needs further study.

Dealing with cultural diversity in palliative care.

Palliative care is increasingly confronted with cultural diversity. This can lead to various problems in practice. In this perspective article, the authors discuss in more detail which issues play a role in culture-sensitive palliative care, why naive culturalism will not solve such problems and in which direction research into this aspect of care can be further elaborated.

Association Between Feeling Threatened, Behaviour and Symptoms of Anxiety and Depression: Two and a Half Years After the Terrorist Attacks in Belgium.

Feeling threatened by terrorism can be associated with mental health problems and behavioural changes. However, few studies look at the association in the long-term. Using a survey, the population in Brussels, Belgium was studied using a representative database delivered by the national post service. The Patient Health Questionnaire-4 (PHQ-4) assessed mental health, and self-made questions avoidance behaviour. 170 people answered: 60% women and 50% higher educated, 28.2% between 56 and 65 years and 62.4% had a partner. 43.5% felt threatened by the terrorist attacks and 45.9% experienced no mental health problems. Both terrorist threat (p < 0.001) and avoidance behaviour (p < 0.001) significantly predicted PHQ-4 scores, while controlling for gender, age, social support, education level, and traumatic events. There is a relation between terrorist threat and anxiety/depressive symptoms 2.5 years after the last study on terrorist threat in Brussels, but it has weakened. Avoidance behaviour seems to be more present than threat.

Suicide in Flanders, Belgium, after terrorist attacks.

Little is known about the association between terrorism and suicide. This study investigates suicide numbers in Flanders, Belgium before and after the Paris-attacks (13/11/2015) and Brussels-attacks (22/03/2016). Population mortality data for suicide were gathered from the Agency for healthcare. Suicides in Flanders, Belgium, were higher after both attacks. The increase was higher after the Paris-attacks, compared to the attacks in Brussels, Belgium. The effect of a close-by, but still foreign attack (the Paris-attacks in France) on suicide numbers is larger than that of an attack inside the country (the Brussels-attacks), possibly due to a difference in threat experience and coping possibilities.

Reporting of Palliative Sedation and Use of Opioids at the End of Life in a Belgian University Hospital: A Pilot Study.

Background: Palliative sedation requires no formal registration in Belgium. For euthanasia, however, there are clear guidelines in certain countries, including mandatory registration and evaluation of cases. Official guidelines have been developed for palliative sedation, but research still shows unskilled use of sedation and unclear demarcation between palliative sedation and euthanasia. Registration could be used to avoid unskilled use of sedation and to avoid use or abuse of sedation to hasten the patient's death (described as "slow/passive euthanasia"). Objective: To evaluate the current practice of palliative sedation and use of opioids and sedatives at the end of life by using a registration document. Design: Retrospective observational study. Setting/Subjects: We included all in-hospital deaths at an academic hospital in Belgium of patients (age ≥18 years) who had received parenteral opioids, benzodiazepines, barbiturates, or other anesthetics during the last 24 hours. Measurements: We investigated indications for palliative sedation, patients' and physicians' characteristics, types of medication used, and the decision-making process with the patients and family. The questionnaires were collected between July 9 and November 25, 2016. The study was approved by the Biomedical Ethics Committee of UZ Brussel (B.U.N. 1432016293). Results: In a population of 124 patients, refractory symptoms were reported in 94.4%. All patients received parenteral opioids (intravenously). Benzodiazepines were used in 51.6%. In 75.8%, physicians reported no change in treatment plan during end of life. Hastening death by increasing analgesics and/or sedatives was mentioned in 19.3%. The treatment plan was discussed with patients in 26.6% of cases. In 6 cases, an explicit intention to hasten death was mentioned; in 36 cases, doses of opioids/sedatives may not have been strictly proportional to symptoms. Conclusion: This Belgian study shows that objective reporting of palliative sedation can be used as a tool to ensure good clinical practice where patients receive the most appropriate end-of-life care, avoiding abusive and injudicious or unskilled use of sedation.

Neurophysiological Assessments During Continuous Sedation Until Death Put Validity of Observational Assessments Into Question: A Prospective Observational Study.

INTRODUCTION: In case of untreatable suffering at the end of life, continuous sedation until death (CSD) may be the only treatment option left. Because these patients cannot communicate anymore, caregivers have to rely on behavioral observation to assess the patient's comfort. Recently, however, a number of studies from the neurosciences have shown that sometimes consciousness and pain are undetectable with these traditional behavioral methods. The aim of this study was to find out if subjective caregiver assessments of consciousness and pain would be confirmed by objective neurophysiological measures. METHODS: In this prospective observational study, we observed patients from the start of palliative sedation until death. Subjective caregiver assessments of level of consciousness and pain based on behavioral observations were compared with objective measures from neurophysiological monitoring devices. RESULTS: We collected and analyzed 108 subjective caregiver assessments in a sample of 12 patients and 32 assessments by traditionally used observational scales. We compared these with objective neurophysiological measures. Sensitivity and specificity of caregivers' subjective assessments of consciousness was 23.6 and 91.1% respectively, with an accuracy of 54.0% and interrater reliability (κ) of 0.13. For pain, this was 0 and 94.79%, respectively, an accuracy of 88%, and an inter-rater reliability (κ) of - 0.063. Agreement between caregivers' subjective assessments and objective neurophysiological measures of consciousness and pain was very poor. CONCLUSIONS: Caregivers' subjective assessment of level of consciousness and pain during CSD is unreliable compared with objective neurophysiological monitoring. Our results suggest that assessments of patient comfort during CSD could have been improved substantially by including objective monitoring of level of consciousness and pain. TRIAL REGISTRATION: The protocol for this observational study has been registered retrospectively at Clinical-Trials.gov (ID NCT03273244).

Attitudes of Professional Caregivers and Family Members Regarding the Use of Monitoring Devices to Improve Assessments of Pain and Discomfort During Continuous Sedation Until Death.

CONTEXT: Assessing consciousness and pain during continuous sedation until death (CSD) by behavior-based observational scales alone has recently been put into question. Instead, the use of monitoring technology has been suggested to make more objective and reliable assessments. Insights into which factors influence attitudes toward using these monitoring devices in a context of CSD is a first step in formulating recommendations to inform future practice. OBJECTIVES: The aim of this study was to find out what influences professional caregivers' and family members' (FMs) attitudes regarding the use of monitors during CSD. METHODS: We conducted semistructured face-to-face interviews with 20 professional caregivers and 15 FMs, who cared for a patient or had an FM, respectively, who took part in a study using monitoring devices. Recruitment took place in an academic hospital, a locoregional hospital, and two nursing homes, all located in Belgium. Two researchers independently analyzed the data, using grounded theory to inductively develop a model that represents the emerging attitude toward use of monitors during CSD. RESULTS: Our model shows that the emerging attitudes toward using monitors during CSD is determined by view on CSD, desire for peace of mind, emotional valence attached to using monitors, and the realization that the sole use of behavior-based observational measures could be unreliable in a CSD context. We identified several facilitators and barriers to inform future implementation strategies. CONCLUSION: Most participants had no objections, and all participants found the use of monitoring devices during CSD feasible and acceptable. We identified a number of facilitators and barriers and suggested that being aware that care can be improved, good communication, shared decision making, and continuing professional education can overcome the identified barriers. We suggest future research would focus on developing implementation strategies and guidelines for introducing objective monitoring devices in diverse palliative care settings.

Questions and Emotions of Minors After Terrorist Attacks: A Qualitative Study Using Data from a Belgian Youth-Helpline.

Until now, there is little research on the experiences of indirectly exposed minors after terrorist attacks. This study sheds light on the emotions and questions of such indirectly exposed minors. A qualitative content analysis of secondary data gained from Awel, a youth-helpline, was performed until saturation. Data contained emotions and questions in chat conversations, with 30 minors (8-18 years old). Emotions included guilt, sadness, and especially fear of attacks on themselves, their family, or at school. Questions mostly focused on making sense of the attacks, and how to distinguish fantasy from reality. After an attack children and adolescents experienced a wide range of emotions, and seem to have difficulty to make sense of what happened. Teachers and parents can play an important role in buffering fears, and in offering contextual information and concrete answers.

Should we include monitors to improve assessment of awareness and pain in unconscious palliatively sedated patients? A case report.

BACKGROUND: Awareness and pain during palliative sedation is typically assessed by observational scales, but the use of such scales has been put into question. CASE PRESENTATION: A woman in her mid-80s was admitted to a palliative care unit, presenting with chronic lymphatic leukemia, depression, and a cerebrovascular accident, with right-sided hemiplegia and aphasia. The patient was unable to eat and was suffering from nausea and vomiting. Before admission, the patient had expressed her desire to discontinue treatment on several occasions. CASE MANAGEMENT: The decision was made to initiate palliative sedation. The patient consented to take part in a study to assess level of comfort and pain using two monitoring devices (NeuroSense monitor and Analgesia Nociception Index monitor). CASE OUTCOME: The patient died 90 h after initiation of palliative sedation. Titration of the medication was challenging and sedation was not deep enough during the first 2 days. Thirteen assessments made with the Ramsay Sedation Scale showed that the patient was considered to be in a deep sleep, while in fact the NeuroSense monitor indicated otherwise. CONCLUSION: This case demonstrates the feasibility and potential advantages of using monitoring devices to objectify assessments of pain and discomfort in palliatively sedated patients.

Are the Elderly Perceived as a Burden to Society? The Perspective of Family Caregivers in Belgium and Kenya: A Comparative Study.

INTRODUCTION: It is estimated that 70% to 80% of informal care for frail and disabled elders is provided by family caregivers (FCGs). AIM: To better understand how caregiving for the elderly has affected FCGs lives and to compare the perspective of these caregivers in Belgium and Kenya. METHOD: Semistructured interviews were undertaken with 15 FCGs in Kenya and 15 FCGs in Belgium. Interpretative phenomenological analysis was used to identify themes. RESULTS: Themes discovered in the experience of family caregiving included profile of the care receiver, impact of caregiving on the FCG, cultural values and norms, challenges in caregiving, coping strategies and caregiver well-being. DISCUSSION: FCGs in both Kenya and Belgium identified experiencing serious concerns. In Kenya, the lack of resources and formal structures play a more important role than in Belgium. Despite this difference, culture-specific views and norms are paramount to explaining the FCG experience in the two countries.

Association between feeling threatened by a terrorist attack and subjective health: a web survey a week after the attacks of 22 March 2016 in Belgium.

Background: The wave of terrorist attacks over the past years in Europe and other regions may cause problems such as anxiety and depressive symptoms. Some studies suggest that perceived threat might also trigger physical health problems. Objective: To investigate the association between feeling threatened and subjective health during the week following a terrorist attack. Method: Online survey with a self-selected sample in the Belgian population one week after the terrorist attacks in 2016. Participants were invited through the Belgian media to fill in a questionnaire in Dutch, French or English on a website. The main outcomes were the association between 'feeling threatened' and subjective health problems. Perceived threat was measured with the question 'During the week after the attacks … Did you feel threatened?' Subjective health was measured by using standardized scales (ACSA, PHQ-4, PHQ-15). Results: A total of 2620 respondents completed the questionnaire, of whom 69.8% were female, 27.7% lived and 43.1% worked in Brussels. Gender, age, place of living and working, media exposure, religiousness and religious affiliation were associated significantly with higher perceived threat. A total of 21% of the respondents felt much or very much threatened during the week after the attacks. They reported significantly higher levels of mental and physical health problems. The most frequently reported problems were anxiety and depressive symptoms. The health problems that differentiated most markedly between those with low and high levels of perceived threat were fainting spells, chest pain and shortness of breath. Conclusion: In a self-selected sample of respondents, 'feeling threatened' was strongly associated with lower level of wellbeing and higher levels of mental and physical health problems. The most prevalent health problems were mental health problems but the most pronounced differences between people with low versus high levels of perceived threat were physical health problems.

Antecedentes: La ola de ataques terroristas en los últimos años en Europa y otras regiones puede causar problemas, tales como síntomas ansiosos y depresivos. Algunos estudios sugieren que la percepción de amenaza puede gatillar problemas de salud física.Objetivo: Investigar la asociación entre el sentimiento de amenaza y la salud subjetiva durante la semana siguiente a un ataque terrorista.Método: Una encuesta en línea con una muestra auto- seleccionada en la población Belga una semana después del ataque terrorista del 2016. Los participantes fueron invitados a través de los medios belgas a llenar un cuestionario en holandés, francés o inglés en un sitio web. Los resultados principales fueron la asociación entre 'el sentirse amenazado' y problemas de salud subjetivos. La amenaza percibida fue medida con la pregunta ¿"Durante la semana posterior a los ataques.se sintió amenazado?". La salud subjetiva fue medida usando escalas estandarizadas (ACSA, PHQ-4, PHQ-15).Resultados: 2.620 encuestados completaron el cuestionario, de los cuales 69,8% eran mujeres, 27,7% vivía en Bruselas y 43,1% trabajaba en esa ciudad. El género, la edad, lugar donde vive y trabaja, la exposición a los medios, religiosidad y pertenencia a una religión estuvieron asociados significativamente con mayor percepción de amenaza. Veintiún por ciento de los encuestados se sentían muy o mucho más amenazado durante la semana posterior a los ataques. Ellos reportaron niveles significativamente más elevados de problemas de salud mental y física. Los problemas más frecuentemente reportados fueron síntomas de ansiedad y depresivos. Los problemas de salud que diferenciaba más marcadamente entre aquellos con niveles bajos y altos de percepción de amenaza fueron desmayos, dolor en el pecho, y dificultades para respirar.Conclusiones: En una muestra auto-seleccionada de encuestados, el 'sentirse amenazado' se asoció fuertemente con niveles más bajos de bienestar y niveles más altos de problemas de salud mental y física. Los problemas de salud más prevalentes fueron los problemas de salud mental, pero las diferencias más pronunciadas entre las personas con niveles bajos versus niveles altos de amenaza percibida fueron los problemas de salud físicos.

Comfort in palliative sedation (Compas): a transdisciplinary mixed method study protocol for linking objective assessments to subjective experiences.

BACKGROUND: In case of untreatable suffering at the end of life, palliative sedation may be chosen to assure comfort by reducing the patient's level of consciousness. An important question here is whether such sedated patients are completely free of pain. Because these patients cannot communicate anymore, caregivers have to rely on observation to assess the patient's comfort. Recently however, more sophisticated techniques from the neurosciences have shown that sometimes consciousness and pain are undetectable with these traditional behavioral methods. The aim of this study is to better understand how unconscious palliative sedated patients experience the last days of their life and to find out if they are really free of pain. METHODS: In this study we will observe 40 patients starting with initiation of palliative sedation until death. Assessment of comfort based on behavioral observations will be related with the results from a NeuroSense monitor, an EEG-based monitor used for evaluation of the adequacy of anesthesia and sedation in the operating room and an ECG-based Analgesia Nociception Index (ANI) monitor, which informs about comfort or discomfort condition, based on the parasympathetic tone. An innovative and challenging aspect of this study is its qualitative approach; "objective" and "subjective" data will be linked to achieve a holistic understanding of the study topic. The following data will be collected: assessment of pain/comfort by the patients themselves (if possible) by scoring a Visual Analogue Scale (VAS); brain function monitoring; monitoring of parasympathetic tone; caregivers' assessment (pain, awareness, communication); relatives' perception of the quality of the dying process; assessment by 2 trained investigators using observational scales; video and audio registration. DISCUSSION: Measuring pain and awareness in non-communicative dying patients is both technically and ethically challenging. ANI and EEG have shown to be promising technologies to detect pain that otherwise cannot be detected with the "traditional" methods. Although these technologies have the potential to provide objective quantifiable indicators for distress and awareness in non-communicative patients, strikingly they have not yet been used to check whether the current assessments for non-communicative patients are reliable. TRIAL REGISTRATION: The study is registered on ClinicalTrials.gov (Identifier: NCT03273244 ; registration date: 7.9.2017).