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临床试验/NCT06307912
NCT06307912已完成不适用

The Effect of Physiotherapists' Placebo or Nocebo Communication About Virtual Reality on Treatment Beliefs in Healthy People

HAN University of Applied Sciences2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
2
主要终点
Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ)

研究概览

简要总结

Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered nonpharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in healthy participants.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in healthy participants.

Study design: Web-based randomized controlled trial.

Study population: 126 participants

Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.

Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • aged ≥ 18
  • access to the internet
  • provide informed consent

排除标准

  • lacked comprehension of the Dutch language
  • had experience with therapeutic VR
  • suffers from CMP

研究组 & 干预措施

Placebo group

Placebo Comparator

The placebo intervention group will be shown an online educational VR video.

干预措施: Video placebo communication (Other)

Nocebo group

Experimental

The nocebo intervention group will be shown an online educational VR video.

干预措施: Video nocebo communication (Other)

结局指标

主要结局

Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ)

时间窗: Baseline and immediately after the intervention

This questionnaire on treatment credibility scores from 5 (lowest credibility) to 45 (highest credibility)

Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ)

时间窗: Baseline and immediately after the intervention

This questionnaire on treatment expectancy scores from 6 (lowest expectancy) to 54 (highest expectancy)

次要结局

  • Change in openness to VR measured using a single question(Baseline and immediately after the intervention)

研究者

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

Bart Staal

Professor (lector)

HAN University of Applied Sciences

研究点 (2)

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