CommunicationNCT06307912
Physiotherapists' Placebo or Nocebo Communication Regarding VR
A study testing Video nocebo communication in people with Communication, 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 nonpharmacological 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 olderHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- Video nocebo communication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2023to 1 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged ≥ 18
- access to the internet
- provide informed consent
Who cannot join
- lacked comprehension of the Dutch language
- had experience with therapeutic VR
- suffers from CMP
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 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.
Read more
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
- Being tested
- Video placebo communication, Video nocebo communication
- Medical subject headings
- Communication
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 enhancing verbal language.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | The placebo intervention group will be shown an online educational VR video. Receives: Other: Video placebo communication |
| Nocebo group | Experimental | 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 (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Nov 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
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
- 126 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
- NCT06307912
- Sponsor's protocol ID
- 202301
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 13 Mar 2024
- 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 13 Mar 2024. 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 Healthy People
- ClinicalTrials.gov ID
- NCT06307912
- Acronym / sponsor ID
- 202301
- Conditions
- Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- HAN University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 13 Mar 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 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 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 | Placebo comparator | Other: Video placebo communicationThe placebo intervention group will be shown an online educational VR video. |
| Nocebo group | Experimental | 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥ 18
- access to the internet
- provide informed consent
Key exclusion criteria (3 listed)
- lacked comprehension of the Dutch language
- had experience with therapeutic VR
- suffers from CMP
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 enhancing 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)
1 secondary outcome
Change in openness to VR measured using a single question
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 13 Mar 2024.
- 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, 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 3 inclusion and 3 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 13 Mar 2024. 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. Some participants in this study may receive a placebo. 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 13 Mar 2024.