Examining the effects of enhanced provider-patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care.

INTRODUCTION: Placebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider's communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients' outcomes. METHODS AND ANALYSIS: Using a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse-patient interactions. ETHICS AND DISSEMINATION: Although communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication. TRIAL REGISTRATION NUMBER: NTR5994; Pre-results.

The Virtual Care Climate Questionnaire: Development and Validation of a Questionnaire Measuring Perceived Support for Autonomy in a Virtual Care Setting.

BACKGROUND: Web-based health behavior change interventions may be more effective if they offer autonomy-supportive communication facilitating the internalization of motivation for health behavior change. Yet, at this moment no validated tools exist to assess user-perceived autonomy-support of such interventions. OBJECTIVE: The aim of this study was to develop and validate the virtual climate care questionnaire (VCCQ), a measure of perceived autonomy-support in a virtual care setting. METHODS: Items were developed based on existing questionnaires and expert consultation and were pretested among experts and target populations. The virtual climate care questionnaire was administered in relation to Web-based interventions aimed at reducing consumption of alcohol (Study 1; N=230) or cannabis (Study 2; N=228). Item properties, structural validity, and reliability were examined with item-response and classical test theory methods, and convergent and divergent validity via correlations with relevant concepts. RESULTS: In Study 1, 20 of 23 items formed a one-dimensional scale (alpha=.97; omega=.97; H=.66; mean 4.9 [SD 1.0]; range 1-7) that met the assumptions of monotonicity and invariant item ordering. In Study 2, 16 items fitted these criteria (alpha=.92; H=.45; omega=.93; mean 4.2 [SD 1.1]; range 1-7). Only 15 items remained in the questionnaire in both studies, thus we proceeded to the analyses of the questionnaire's reliability and construct validity with a 15-item version of the virtual climate care questionnaire. Convergent validity of the resulting 15-item virtual climate care questionnaire was confirmed by positive associations with autonomous motivation (Study 1: r=.66, P<.001; Study 2: r=.37, P<.001) and perceived competence for reducing alcohol intake (Study 1: r=.52, P<.001). Divergent validity could only be confirmed by the nonsignificant association with perceived competence for learning (Study 2: r=.05, P=.48). CONCLUSIONS: The virtual climate care questionnaire accurately assessed participants' perceived autonomy-support offered by two Web-based health behavior change interventions. Overall, the scale showed the expected properties and relationships with relevant concepts, and the studies presented suggest this first version of the virtual climate care questionnaire to be reasonably valid and reliable. As a result, the current version may cautiously be used in future research and practice to measure perceived support for autonomy within a virtual care climate. Future research efforts are required that focus on further investigating the virtual climate care questionnaire's divergent validity, on determining the virtual climate care questionnaire's validity and reliability when used in the context of Web-based interventions aimed at improving nonaddictive or other health behaviors, and on developing and validating a short form virtual climate care questionnaire.