Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-01 @ 12:21 AM
Study NCT ID:
NCT04098627
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2019-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Laughter Therapy on Hemodialysis on Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D007845', 'term': 'Laughter'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009633', 'term': 'Nonverbal Communication'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D027641', 'term': 'Laughter Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statistical Analysis Blinded'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2019-09-19', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': '8 weeks', 'description': 'Change in General Anxiety Disorder Scale 2 (GAD -2) in intervention group compared to change in the usual care group. The construct is the screening measure of depression which is calculated by the sum of 2 items on a scale of 0 to 3. A score of 3 or greater for depression is considered positive for screening purposes. The higher the sore the greater the chance of depression risk and thus the worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': '8 weeks', 'description': 'Change in the anxiety subscale of the Patient Health Questionnaire 4 (PHQ4) in intervention group compared to change in the usual care group.The construct is the screening measure of anxiety which is calculated by the sum of 2 items on a scale of 0 to 3. A score of 3 or greater for anxiety is considered positive for screening purposes. The higher the sore the greater the chance of anxiety risk and thus the worse outcome.'}, {'measure': 'Subjective Wellbeing', 'timeFrame': '8 weeks', 'description': 'Change in Subjective Wellbeing using the 7 item Personal Wellbeing Index (PWI) in the intervention group compared to change in the usual care group. Subjective wellbeing measures the construct of long term happiness. The Personal Wellbeing Index (PWI) is a 7 item validated scale that rates satisfaction with life in seven domains: standard of living, health, achievements in life, relationships, safety, community and future security, on an 11-point scale. The higher the rating the better the outcome. Measures are individually scored and cumulatively scored.'}, {'measure': 'Patient reported outcome measures (PROMs)', 'timeFrame': '8 weeks', 'description': 'Change in PROMS using the 6 item London Evaluation of Illness (LEVIL) in the intervention group compared to change in the usual care group. LEVIL is a 6 item visual analogue scale (VAS) developed and used in hemodialysis patients that measures general wellbeing (GWB), pain, sleep, breathing, energy, and appetite. The anchors for GWB, sleep and appetite were "very poor"-"excellent," for pain and breathing "extreme"-"no problem" and for energy "extremely fatigued"-"full of energy." For each domain the VAS allowed free selection of status along a line from worst (0) to best (100). Measures are individually scored and cumulatively scored.'}, {'measure': 'Psychological Distress - Patient Health Questionnaire 4 (PHQ4)', 'timeFrame': '8 weeks', 'description': 'Change in Psychological Distress, as measured by the Patient Health Questionnaire 4 (PHQ4), in intervention group compared to change in the usual care group. The construct is the screening measure of psychological distress which is calculated by the sum of 4 items on a scale of 0 to 3. A score of 0 to 2 is no distress, 3-5 is mild distress, 6-8 is moderate distress and 9-12 is severe distress. The higher the sore the greater the psychological distress and thus the worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laughter', 'depression', 'hemodialysis'], 'conditions': ['End Stage Kidney Disease']}, 'descriptionModule': {'briefSummary': 'End stage kidney disease is associated with increased depression. Laughter is associated with improvement in depression in chronic disease. The study objective was to measure the effect of intradialytic group laughter therapy on anxiety and depression. Pragmatic randomized controlled trial conducted in 10 hemodialysis centers in Northern California. The intervention group received a once weekly 30-minute long group laughter therapy session for 8 weeks. Primary outcome was depression score as measured using the Patient Health Questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of end stage kidney disease (ESKD) and currently undergoing hemodialysis at a Satellite Healthcare Hemodialysis Center\n* Ability to understand English\n\nExclusion Criteria:\n\n* Cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04098627', 'acronym': 'LOL-HD', 'briefTitle': 'The Effects of Laughter Therapy on Hemodialysis on Depression', 'organization': {'class': 'OTHER', 'fullName': 'Satellite Healthcare'}, 'officialTitle': 'The Effects of Laughter Therapy on Hemodialysis on Depression: A Pragmatic Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SIH109_LOLRCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Once weekly 30-minute long group laughter therapy session for 8 weeks while patients are on dialysis', 'interventionNames': ['Behavioral: Laughter Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual care'}], 'interventions': [{'name': 'Laughter Therapy', 'type': 'BEHAVIORAL', 'description': 'Once weekly 30-minute long group laughter therapy session for 8 weeks', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95821', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}], 'overallOfficials': [{'name': 'Paul N Bennett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Satellite Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We plan to keep all data confidential unless requested by statutory body.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Satellite Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}