CommunicationNCT06282757
Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP
A study testing Video nocebo communication in people with Communication and Chronic Pain, run by HAN University of Applied Sciences at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Chronic Pain
- What is being tested?
- Video nocebo communication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥ 18
- access to the internet
- provide informed consent
- suffers from CMP
Who cannot join
- lacked comprehension of the Dutch language
- had experience with therapeutic VR
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
HAN University of Applied Sciences
Nijmegen, Overijssel, 6525EN
About this study
Official title: The Effect of Physiotherapists' Placebo or Nocebo Communication About Virtual Reality on Treatment Beliefs in Patients With CMP
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
Read more
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).
- Conditions
- Communication, Chronic Pain
- Being tested
- Video placebo communication, Video nocebo communication
- Medical subject headings
- Communication, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video placebo communicationOther
The placebo communication video comprises of an educational VR video containing placebo enhancing verbal language.
Video nocebo communicationOther
The nocebo communication video comprises of an educational VR video containing nocebo stimulating verbal language.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Experimental | The placebo intervention group will be shown an online educational VR video. Receives: Other: Video placebo communication |
| Nocebo group | Active comparator | The nocebo intervention group will be shown an online educational VR video. Receives: Other: Video nocebo communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline and immediately after the intervention
Secondary outcomes (2)
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
Measured: Baseline and immediately after the intervention
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)
This questionnaire on pain intensity scores from 0 (no pain) to 10 (maximal pain)
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAN University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart Staal, HAN University of Applied Sciences
- Investigators
- Bart Staal, PhD, Principal investigator, HAN University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282757
- Sponsor's protocol ID
- 202302
- Status last verified
- Sep 2025
- First submitted
- 21 Feb 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physiotherapists' Placebo or Nocebo Communication About Virtual Reality on Treatment Beliefs in Patients With CMP
- ClinicalTrials.gov ID
- NCT06282757
- Acronym / sponsor ID
- 202302
- Conditions
- Communication, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- HAN University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Experimental | Other: Video placebo communicationThe placebo intervention group will be shown an online educational VR video. |
| Nocebo group | Active comparator | Other: Video nocebo communicationThe nocebo intervention group will be shown an online educational VR video. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged ≥ 18
- access to the internet
- provide informed consent
- suffers from CMP
Key exclusion criteria (2 listed)
- lacked comprehension of the Dutch language
- had experience with therapeutic VR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video placebo communicationThe placebo communication video comprises of an educational VR video containing placebo enhancing verbal language. | Other | Placebo group |
| Video nocebo communicationThe nocebo communication video comprises of an educational VR video containing nocebo stimulating verbal language. | Other | Nocebo group |
Primary outcome
Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ)
Time frame: 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)
Time frame: Baseline and immediately after the intervention
This questionnaire on treatment credibility scores from 5 (lowest credibility) to 45 (highest credibility)
2 secondary outcomes
Change in openness to VR measured using a single question
Time frame: Baseline and immediately after the intervention
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)
Time frame: Baseline and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. Not planned to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Staal, PhD principal investigator
HAN University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video nocebo communication in people with Communication and Chronic Pain, run by HAN University of Applied Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ) (time frame: Baseline and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.