Physiotherapists' Placebo or Nocebo Communication Regarding VR

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

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).

Study Overview

• Status: Completed
• Conditions: Communication
• Intervention / Treatment: Other: Video placebo communication; Other: Video nocebo communication

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Nijmegen, Overijssel, Netherlands, 6525EN
      • HAN University of Applied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; The placebo intervention group will be shown an online educational VR video.	Other: Video placebo communication; The placebo communication video comprises of an educational VR video containing placebo enhancing verbal language.
Experimental: Nocebo group; The nocebo intervention group will be shown an online educational VR video.	Other: Video nocebo communication; The nocebo communication video comprises of an educational VR video containing nocebo enhancing verbal language.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in openness to VR measured using a single question	The question "would you be open to treatment with therapeutic VR" was scored with a yes/no	Baseline and immediately after the intervention

Collaborators and Investigators

• Sponsor: HAN University of Applied Sciences
• Investigators: Principal Investigator: Bart Staal, PhD, HAN University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not planned to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No