Physiotherapists' Placebo or Nocebo Communication Regarding VR

NCT06307912 | Completed

• 1 other identifier: 202301
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Communication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in openness to VR measured using a single question

  Baseline and immediately after the intervention

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Other: Video placebo communication

Nocebo group

EXPERIMENTAL

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

Other: Video nocebo communication

Interventions

Video placebo communication OTHER

The placebo communication video comprises of an educational VR video containing placebo enhancing verbal language.

Placebo group

Video nocebo communication OTHER

The nocebo communication video comprises of an educational VR video containing nocebo enhancing verbal language.

Nocebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HAN University of Applied Sciences: lead

Study Sites (1)

HAN University of Applied Sciences

Nijmegen, Overijssel, 6525EN, Netherlands

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Bart Staal, PhD

  HAN University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (lector)

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 13, 2024
• Study Start: November 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)