Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Communication
• Interventions: Other: Video nocebo communication; Other: Video placebo communication

• Registration Number: NCT06282757
• Lead Sponsor: HAN University of Applied Sciences

Brief Summary

Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological 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 patients with CMP.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMP

Study design: Web-based randomized controlled trial.

Study population: 100 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07
• Study Start: 2024-04-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• aged ≥ 18
• access to the internet
• provide informed consent
• suffers from CMP

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nocebo group	Video nocebo communication	The nocebo intervention group will be shown an online educational VR video.
Placebo group	Video placebo communication	The placebo intervention group will be shown an online educational VR video.

Primary Outcome Measures

Name	Time	Method
Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ)	Baseline and immediately after the intervention	This questionnaire on treatment expectancy scores from 6 (lowest expectancy) to 54 (highest expectancy)
Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ)	Baseline and immediately after the intervention	This questionnaire on treatment credibility scores from 5 (lowest credibility) to 45 (highest credibility)

Secondary Outcome Measures

Name	Time	Method
Change in openness to VR measured using a single question	Baseline and immediately after the intervention	The question "would you be open to treatment with therapeutic VR" was scored with a yes/no
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)	Baseline and immediately after the intervention	This questionnaire on pain intensity scores from 0 (no pain) to 10 (maximal pain)

Trial Locations

Locations (1)

HAN University of Applied Sciences; 🇳🇱 Nijmegen, Overijssel, Netherlands