Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-05 @ 3:00 PM
Study NCT ID:
NCT03063333
Status:
TERMINATED
Last Update Posted:
2019-12-12
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effect of Hypnosis in Spinal Cord Injury Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Head of project stopped', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-10', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Side effects', 'timeFrame': 'For 14 days post-intervention', 'description': 'patient report'}], 'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'For 14 days post-intervention', 'description': 'NRS (0-10)'}, {'measure': 'Coping', 'timeFrame': 'For 14 days post-intervention', 'description': 'Coping strategies questionnaire'}], 'secondaryOutcomes': [{'measure': 'Pain catastrophizing', 'timeFrame': 'For 14 days post-intervention', 'description': 'Pain catastrophizing scale'}, {'measure': 'Pain impact on mood, sleep and daily activities', 'timeFrame': 'For 14 days post-intervention', 'description': 'NRS (0-10)'}, {'measure': 'Anxiety', 'timeFrame': 'For 14 days post-intervention', 'description': 'Hospital Anxiety and Depression Scale'}, {'measure': 'Depression', 'timeFrame': 'For 14 days post-intervention', 'description': 'Hospital Anxiety and Depression Scale'}, {'measure': 'Global impression of change', 'timeFrame': 'For 14 days post-intervention', 'description': 'Global impression of change scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal cord injury', 'hypnosis', 'pain', 'pain catastrophizing', 'coping'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '26871534', 'type': 'BACKGROUND', 'citation': 'Kjogx H, Kasch H, Zachariae R, Svensson P, Jensen TS, Vase L. Experimental manipulations of pain catastrophizing influence pain levels in patients with chronic pain and healthy volunteers. Pain. 2016 Jun;157(6):1287-1296. doi: 10.1097/j.pain.0000000000000519.'}]}, 'descriptionModule': {'briefSummary': 'Coping-oriented hypnotic suggestions aimed at reducing pain catastrophizing was shown to reduce pain in people with chronic tension-type headache and experimental pain in healthy volunteers during hypnosis (Kjøgx et al., 2016). However, the duration of the effect on pain post-hypnosis is unknown.\n\nThe aim is to investigate the durational effect of a single session of coping-oriented hypnotic suggestions on chronic pain in patients with spinal cord injury. If effective for a longer period post-hypnosis, this form of hypnosis may provide an alternative to medicine or may be used in conjunction with lower medicine dosages.\n\nMethods: 75 patients with spinal cord injury and pain is randomized into one of three conditions; coping-oriented hypnosis plus current treatment, neutral hypnosis plus current treatment or current treatment only. Pain intensity, coping strategies, pain catastrophizing, anxiety and depression is assessed before intervention and over a period of 14 days post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal cord injury (tetraplegia or paraplegia) with some preservation of hand functioning\n* Baseline pain level of ≥ 3 on a Numeric Rating Scale (NRS; 0-10 where 10 is extremely severe pain)\n* Pain duration of at least 8 weeks.\n\nExclusion Criteria:\n\n* Severe mental or psychiatric illness\n* Substance abuse (drugs, alcohol or medicine)\n* Lack of ability to cooperate during the experiment\n* Severe high cervical lesions\n* Severe autonomic dysautonomia'}, 'identificationModule': {'nctId': 'NCT03063333', 'briefTitle': 'Long-term Effect of Hypnosis in Spinal Cord Injury Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central Jutland Regional Hospital'}, 'officialTitle': 'Long-term Effect of Hypnosis in Spinal Cord Injury Patients', 'orgStudyIdInfo': {'id': '240929'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coping-oriented hypnosis', 'interventionNames': ['Other: Coping-oriented hypnosis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Neutral hypnosis', 'interventionNames': ['Other: Neutral hypnosis']}, {'type': 'NO_INTERVENTION', 'label': 'current treatment only'}], 'interventions': [{'name': 'Coping-oriented hypnosis', 'type': 'OTHER', 'description': 'Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.', 'armGroupLabels': ['Coping-oriented hypnosis']}, {'name': 'Neutral hypnosis', 'type': 'OTHER', 'description': 'Hypnosis using neutral suggestions plus current treatment', 'armGroupLabels': ['Neutral hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Spinal Cord Injury Centre of Western Denmark', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'overallOfficials': [{'name': 'Helge Kasch, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Spinal Cord Injury Centre of Western Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lone Knudsen, MSc Psych, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Psychologist', 'investigatorFullName': 'Lone Knudsen, MSc Psych, PhD', 'investigatorAffiliation': 'Central Jutland Regional Hospital'}}}}