Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-29 @ 12:43 AM
Study NCT ID:
NCT04786405
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2021-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The experimenter will remain blind to participant condition.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-blind, two-arm, parallel-group randomized design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2021-02-28', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain unpleasantness', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'Numerical rating scale in response to exposure to a cold pressor task.'}, {'measure': 'Pain intensity', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'Numerical rating scale in response to exposure to a cold pressor task.'}, {'measure': 'Pain tolerance', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'How long (in seconds) participants tolerate the cold pressor task with the time starting at the point of immersion and stopping when the hand, wrist and forearm were withdrawn from the refrigerated water.'}], 'secondaryOutcomes': [{'measure': 'Physiological response to pain stimulus', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'Heart rate data'}, {'measure': 'Mechanism: Attention Network Task', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'A computer based task that has been developed to allow assessment of the functioning of the three major attentional networks; alerting, orienting, and executive attention.'}, {'measure': 'Mechanism: Mind Wandering Task', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'A computer based task that has been developed to allow assessment of three types of mind wandering.'}, {'measure': 'Mechanism: Mindfulness', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'Five Facet Mindfulness Questionnaire-Short Form'}, {'measure': 'Mechanism: Pain catastrophizing', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'Pain Catastrophizing Scale'}, {'measure': 'Mechanism: Pain appraisals', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'Pain Appraisal Inventory'}, {'measure': 'Mechanism: Pain-Related Cognitive Processes', 'timeFrame': 'Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)', 'description': 'Pain-Related Cognitive Process Questionnaire34'}, {'measure': 'Mechanism: Hypnotizability', 'timeFrame': 'Baseline score at Experimental Session 1 (Day 1)', 'description': 'Stanford Clinical Hypnotizability Scale'}, {'measure': 'Mechanism: Pre-treatment expectancies', 'timeFrame': 'Baseline score at Experimental Session 1 (Day 1)', 'description': 'Treatment Expectations Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness Meditation', 'Hypnosis', 'Acute Pain', 'Experimental Pain', 'Mechanisms'], 'conditions': ['Mindfulness Meditation', 'Clinical Hypnosis']}, 'descriptionModule': {'briefSummary': 'This trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain.', 'detailedDescription': 'Participants (N=200 with complete data) will be healthy undergraduate students or community-based individuals. An experimental, randomised trial will be implemented, with participants randomly assigned to either five daily, 20-minute mindfulness meditation sessions or clinical hypnosis sessions. Repeated measures and experimental pain manipulation will be implemented. Aim 1 is to examine the effects of these two treatments on experimental pain outcomes. Aim 2 is to examine the moderators of these effects. Aim 3 is to determine the mediators underlying improved experimental pain outcomes. Results will refine theory and will inform the future streamlining of treatments to target those mechanisms shown to be of most critical importance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older;\n* Able to read, speak and understand English.\n\nExclusion Criteria:\n\n* Pregnancy, heart or vascular disease, Raynaud's disease, sickle cell disease, seizure disorder, high blood pressure, or diabetes;\n* Experience of recurrent fainting spells;\n* Report of a chronic pain condition;\n* Use of alcohol and/or pain medication in the last 24-hours;\n* Currently receiving psychiatric care;\n* Problems with allergic skin reactions or excessive bruising;\n* Previous participation in a cold pressor experiment.\n* All participants will be asked to consume a fruit box drink prior to the cold pressor to prevent vasovagal reactions.\n\nThese exclusion criteria are standard when using a cold pressor task in a healthy undergraduate population and ensure safe procedures to mitigate any potential risks."}, 'identificationModule': {'nctId': 'NCT04786405', 'briefTitle': 'Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain', 'organization': {'class': 'OTHER', 'fullName': 'The University of Queensland'}, 'officialTitle': 'An Experimental, Randomized Trial Comparing Mindfulness Meditation Versus Clinical Hypnosis for Acute Pain: a Test of Effects and Mechanisms', 'orgStudyIdInfo': {'id': '#2019000347'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness Meditation', 'description': 'Participants in this arm will complete five, 20-minute mindfulness meditation sessions delivered over consecutive days.', 'interventionNames': ['Behavioral: Mindfulness meditation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clinical Hypnosis', 'description': 'Participants in this arm will complete five, 20-minute clinical hypnosis sessions delivered over consecutive days.', 'interventionNames': ['Behavioral: Clinical hypnosis']}], 'interventions': [{'name': 'Mindfulness meditation', 'type': 'BEHAVIORAL', 'description': 'Participants in the mindfulness meditation condition will practice a breath and body focused meditation.', 'armGroupLabels': ['Mindfulness Meditation']}, {'name': 'Clinical hypnosis', 'type': 'BEHAVIORAL', 'description': 'Participants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals.', 'armGroupLabels': ['Clinical Hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4072', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The University of Queensland', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will make available to interested researchers a data file containing the de-identified data used for each published article at the time that the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all of the variables used in any published article and a list of the variables in the data file (along with their variable labels) and email to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a copy of the data set (as an SPSS.sav file).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Queensland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}