Measuring hot flash phenomenonology using ambulatory prospective digital diaries.

OBJECTIVE: This study provides the description, protocol, and results from a novel prospective ambulatory digital hot flash phenomenon diary. METHODS: This study included 152 midlife women with daily hot flashes who completed an ambulatory electronic hot flash diary continuously for the waking hours of three consecutive days. In this diary, women recorded their hot flashes and accompanying characteristics and associations as the hot flashes occurred. RESULTS: Self-reported hot flash severity on the digital diaries indicated that the majority of hot flashes were rated as mild (41.3%) or moderate (43.7%). Severe (13.1%) and very severe (1.8%) hot flashes were less common. Hot flash bother ratings were rated as mild (43%), or moderate (33.5%), with fewer hot flashes reported bothersome (17.5%) or very bothersome (6%). The majority of hot flashes were reported as occurring on the face (78.9%), neck (74.7%), and chest (61.3%). Of all reported hot flashes, 32% occurred concurrently with prickly skin, 7% with anxiety, and 5% with nausea. A novel finding from the study was that 38% of hot flashes were accompanied by a premonitory aura. CONCLUSIONS: A prospective electronic digital hot flash diary allows for a more precise quantitation of hot flashes while overcoming many of the limitations of commonly used retrospective questionnaires and paper diaries. Unique insights into the phenomenology, loci, and associated characteristics of hot flashes were obtained using this device. The digital hot flash phenomenology diary is recommended for future ambulatory studies of hot flashes as a prospective measure of the hot flash experience.

Hypnotic relaxation therapy for reduction of hot flashes in postmenopausal women: examination of cortisol as a potential mediator.

Hypnotic relaxation therapy (HRT) has been shown to reduce hot flashes in postmenopausal women and breast cancer survivors. While the biological mechanism by which HRT reduces hot flashes is unknown, it has been speculated that reduction of stress mediates the intervention's effectiveness. The purpose of the present study was to examine the effect of HRT on a known biomarker of stress (cortisol) and changes in cortisol as a mediator. Sixty-two postmenopausal women received hypnotic relaxation therapy for hot flashes and completed measures of hot flashes in addition to providing cortisol samples at baseline and endpoint. HRT resulted in significantly decreased early evening salivary cortisol concentrations. However, changes in salivary cortisol concentrations did not mediate the effects of HRT.

Clinical hypnosis in the treatment of postmenopausal hot flashes: a randomized controlled trial.

OBJECTIVE: The use of estrogen and progesterone to manage vasomotor symptoms (ie, hot flashes and night sweats) has declined because of concerns about their risks, and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized controlled trial of clinical hypnosis for treating vasomotor symptoms among postmenopausal women. METHODS: This is a randomized, single-blind, controlled, clinical trial involving 187 postmenopausal women reporting a minimum of seven hot flashes per day (or at least 50 hot flashes a week) at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries on weeks 2 to 6 and week 12. Secondary outcomes included measures of hot flash-related daily interference, sleep quality, and treatment satisfaction. RESULTS: In a modified intent-to-treat analysis that included all randomized participants who provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 (74.16%) hot flashes for the clinical hypnosis intervention versus a mean reduction of 12.89 (17.13%) hot flashes for controls (P < 0.001; 95% CI, 36.15-49.67). The mean reduction in hot flash score was 18.83 (80.32%) for the clinical hypnosis intervention as compared with 3.53 (15.38%) for controls (P < 0.001; 95% CI, 12.60-17.54). At 12-week follow-up, the mean reduction in physiologically monitored hot flashes was 5.92 (56.86%) for clinical hypnosis and 0.88 (9.94%) for controls (P < 0.001; 95% CI, 2.00-5.46). Secondary outcomes were significantly improved compared with controls at 12-week follow-up: hot flash-related interference (P < 0.001; 95% CI, 2.74-4.02), sleep quality (P < 0.001; 95% CI, 3.65-5.84), and treatment satisfaction (P < 0.001; 95% CI, 7.79-8.59). CONCLUSIONS: Compared with structured-attention control, clinical hypnosis results in significant reductions in self-reported and physiologically measured hot flashes and hot flash scores in postmenopausal women.

Risk factors, pathophysiology, and treatment of hot flashes in cancer.

Hot flashes are prevalent and severe symptoms that can interfere with mood, sleep, and quality of life for women and men with cancer. The purpose of this article is to review existing literature on the risk factors, pathophysiology, and treatment of hot flashes in individuals with cancer. Electronic searches were conducted to identify relevant English-language literature published through June 15, 2012. Results indicated that risk factors for hot flashes in cancer include patient-related factors (eg, age, race/ethnicity, educational level, smoking history, cardiovascular risk including body mass index, and genetics) and disease-related factors (eg, cancer diagnosis and dose/type of treatment). In addition, although the pathophysiology of hot flashes has remained elusive, these symptoms are likely attributable to disruptions in thermoregulation and neurochemicals. Therapies that have been offered or tested fall into 4 broad categories: pharmacological, nutraceutical, surgical, and complementary/behavioral strategies. The evidence base for this broad range of therapies varies, with some treatments not yet having been fully tested or showing equivocal results. The evidence base surrounding all therapies is evaluated to enhance hot flash treatment decision-making by clinicians and patients.

Initial development of a brief measure of psychological distress.

This paper addresses the preliminary development, construct validity, and psychometric properties of a brief self-report measure of psychological distress. 40 items were originally generated by doctoral level psychologists for use in the preliminary clinical sample. Inpatients from a psychiatric unit (N = 125) completed the items, and a principal-components analysis with a direct oblimin rotation was used to evaluate construct validity. The study indicated a four-factor solution, using the constructs of Depression, Hopelessness, Anxiety, and Anger, with good estimates of reliability. After evaluation of factor structure, item analyses, and reliability estimates, a redacted 19-item scale was identified.

Hypnosis for hot flashes among postmenopausal women study: a study protocol of an ongoing randomized clinical trial.

BACKGROUND: Hot flashes are a highly prevalent problem associated with menopause and breast cancer treatments. The recent findings from the Women's Health Initiative have important implications for the significance of a non-hormonal, mind-body intervention for hot flashes in breast cancer survivors. Women who take hormone therapy long-term may have a 1.2 to 2.0 fold increased risk of developing breast cancer. In addition, it is now known that hormone therapy with estrogen and progestin is associated with increased risk of cardiovascular disease and stroke. Currently there are limited options to hormone replacement therapy as non-hormonal pharmacological agents are associated with only modest activity and many adverse side effects. Because of this there is a need for more alternative, non-hormonal therapies. Hypnosis is a mind-body intervention that has been shown to reduce self-reported hot flashes by up to 68% among breast cancer survivors, however, the use of hypnosis for hot flashes among post-menopausal women has not been adequately explored and the efficacy of hypnosis in reducing physiologically measured hot flashes has not yet been determined. METHODS/DESIGN: A sample of 180 post-menopausal women will be randomly assigned to either a 5-session Hypnosis Intervention or 5-session structured-attention control with 12 week follow-up. The present study will compare hypnosis to a structured-attention control in reducing hot flashes (perceived and physiologically monitored) in post-menopausal women in a randomized clinical trial. Outcomes will be hot flashes (self-report daily diaries; physiological monitoring; Hot Flash Related Daily Interference Scale), anxiety (State-Trait Anxiety Inventory; Hospital Anxiety and Depression Scale (HADS); anxiety visual analog scale (VAS rating); depression (Center for Epidemiologic Studies Depression Scale), sexual functioning (Sexual Activity Questionnaire), sleep quality (Pittsburgh Sleep Quality Index) and cortisol. DISCUSSION: This study will be the first full scale test of hypnosis for hot flashes; one of the first studies to examine both perceived impact and physiologically measured impact of a mind-body intervention for hot flashes using state-of-the-art 24 hour ambulatory physiological monitoring; the first study to examine the effect of hypnosis for hot flashes on cortisol; and the first investigation of the role of cognitive expectancies in treatment of hot flashes in comparison to a Structured-Attention Control. TRIAL REGISTRATION: This clinical trial has been registered with ClinicalTrials.gov, a service of the U.S. National Institutes of Health, ClinicalTrials.gov Identifier: NCT01293695.