Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 3:26 PM
Study NCT ID:
NCT06282757
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2024-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ)', 'timeFrame': 'Baseline and immediately after the intervention', 'description': 'This questionnaire on treatment expectancy scores from 6 (lowest expectancy) to 54 (highest expectancy)'}, {'measure': 'Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ)', 'timeFrame': 'Baseline and immediately after the intervention', 'description': 'This questionnaire on treatment credibility scores from 5 (lowest credibility) to 45 (highest credibility)'}], 'secondaryOutcomes': [{'measure': 'Change in openness to VR measured using a single question', 'timeFrame': 'Baseline and immediately after the intervention', 'description': 'The question "would you be open to treatment with therapeutic VR" was scored with a yes/no'}, {'measure': 'Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'Baseline and immediately after the intervention', 'description': 'This questionnaire on pain intensity scores from 0 (no pain) to 10 (maximal pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Communication', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': "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.\n\nObjective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMP\n\nStudy design: Web-based randomized controlled trial.\n\nStudy population: 100 participants\n\nIntervention: 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.\n\nPrimary 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥ 18\n* access to the internet\n* provide informed consent\n* suffers from CMP\n\nExclusion Criteria:\n\n* lacked comprehension of the Dutch language\n* had experience with therapeutic VR'}, 'identificationModule': {'nctId': 'NCT06282757', 'briefTitle': "Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP", 'organization': {'class': 'OTHER', 'fullName': 'HAN University of Applied Sciences'}, 'officialTitle': "The Effect of Physiotherapists' Placebo or Nocebo Communication About Virtual Reality on Treatment Beliefs in Patients With CMP", 'orgStudyIdInfo': {'id': '202302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo group', 'description': 'The placebo intervention group will be shown an online educational VR video.', 'interventionNames': ['Other: Video placebo communication']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nocebo group', 'description': 'The nocebo intervention group will be shown an online educational VR video.', 'interventionNames': ['Other: Video nocebo communication']}], 'interventions': [{'name': 'Video placebo communication', 'type': 'OTHER', 'description': 'The placebo communication video comprises of an educational VR video containing placebo enhancing verbal language.', 'armGroupLabels': ['Placebo group']}, {'name': 'Video nocebo communication', 'type': 'OTHER', 'description': 'The nocebo communication video comprises of an educational VR video containing nocebo stimulating verbal language.', 'armGroupLabels': ['Nocebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525EN', 'city': 'Nijmegen', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'HAN University of Applied Sciences'}], 'overallOfficials': [{'name': 'Bart Staal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HAN University of Applied Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planned to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HAN University of Applied Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (lector)', 'investigatorFullName': 'Bart Staal', 'investigatorAffiliation': 'HAN University of Applied Sciences'}}}}