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临床试验/NCT04973839
NCT04973839已完成不适用

Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention

Philipps University Marburg2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Change in perceived stress

研究概览

简要总结

This study aims to determine whether a brief video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) can enhance the efficacy of a PMR compared to a neutral video control group in an online intervention. Another aim is to assess whether this effect will be moderated by the degree of human support (guided or unguided intervention).

详细描述

This study aims to determine whether a brief video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) can enhance the efficacy of a PMR session compared to a neutral video control group in an online intervention. Another aim is to assess whether this effect will be moderated by the degree of human support (guided or unguided intervention). After the baseline assessment, participants are randomized to one of 4 possible intervention groups: i) watching a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided), ii) watching a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided), iii) watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided), or iv) watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided). In a pre-posttest design, the subjective stress levels of the participants in the for groups will be analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy participants
  • fluency in the German language to provide informed consent

排除标准

  • muscle disease, muscle cramps, acute psychosis, acute trauma responses, or another chronic somatic illness
  • Mental disorder

结局指标

主要结局

Change in perceived stress

时间窗: Change from pre (baseline) to post scores (30 minutes later)

Participants are asked to rate how stressed they feel at the moment at two time points (baseline and after the PMR intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores). More negative change scores are better since it indicates a stronger stress reduction (maximum reduction: -100). Higher positive change scores are worse since this indicates an increase in perceived stress (maximum increase: +100). Range of change scores: -100 - +100).

次要结局

  • Change in positive affect(Change from pre (baseline) to post scores (30 minutes later))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Winfried Rief

Prof. Dr.

Philipps University Marburg

研究点 (2)

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