Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-04 @ 5:32 AM
Study NCT ID:
NCT06805058
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Comedy Therapy on Pain and Anxiety Levels After Ureterorenoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'It will be conducted as a randomized controlled experimental study in a pre-testpost- test control group experimental model.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain level', 'timeFrame': 'It will take approximately 5 minutes', 'description': 'Patients\' pain level will be measured with a "numerical rating scale". In the form, 0 points are evaluated as "no pain", 1-3 points as "mild pain", 4-6 points as "moderate pain", 7 and above points as "severe pain".'}, {'measure': 'anxiety level', 'timeFrame': 'It will take approximately 30 minutes', 'description': 'State and Trait Anxiety Scale:\n\nThe adaptation and arrangement of the scales to Turkish was made by Necla Öner and Le Compte. Both scales consist of 20 items and are graded on a 4-point Likert scale. Scoring is done between 1-4.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['comedy therapy', 'pain', 'anxiety', 'surgery'], 'conditions': ['Care Acceptor, Health', 'Pain, Postoperative', 'Anxiety Postoperative', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The aim is to determine the effect of comedy therapy on pain and anxiety levels in patients after Uretero-Renoscopy (URS) surgery.\n\nThe hypotheses of this study; H1-0: Comedy therapy has no effect on pain levels in patients after Uretero-Renoscopy surgery.\n\nH1-1: Comedy therapy has an effect on pain levels in patients after Uretero-Renoscopy surgery.\n\nH2-0: Comedy therapy has no effect on anxiety levels in patients after Uretero-Renoscopy surgery.\n\nH2-1: Comedy therapy has an effect on anxiety levels in patients after Uretero-Renoscopy surgery.', 'detailedDescription': 'Intervention Group\n\nAfter URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. Patients will be shown 10-minute Turkish comedy films prepared by the researchers. After the intervention, numerical rating scale, state-trait anxiety scales will be given as a post-test.\n\nControl Group\n\nAfter URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. No intervention will be made to control group patients. After a certain waiting period, numerical rating scale, state-trait anxiety scales will be given as a post-test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years old,\n* Not having any visual or auditory problems,\n* Not having any communication problems,\n* Not having any psychiatric problems.\n\nExclusion Criteria:\n\n* Not accepting to participate in the study or wanting to leave,\n* Having had complications during the perioperative process.'}, 'identificationModule': {'nctId': 'NCT06805058', 'briefTitle': 'Effect of Comedy Therapy on Pain and Anxiety Levels After Ureterorenoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Bitlis Eren University'}, 'officialTitle': 'Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University', 'orgStudyIdInfo': {'id': 'okutan4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group: Comedy therapy', 'description': 'After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. Patients will be shown 10-minute Turkish comedy films prepared by the researchers. After the intervention, numerical rating scale, state-trait anxiety scales will be given as a post-test.', 'interventionNames': ['Other: comedy therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. No intervention will be made to control group patients. After a certain waiting period, numerical rating scale, state-trait anxiety scales will be given as a post-test.'}], 'interventions': [{'name': 'comedy therapy', 'type': 'OTHER', 'description': 'Patients will be shown 10-minute Turkish comedy films prepared by the researchers', 'armGroupLabels': ['Intervention Group: Comedy therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Bitlis', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'şerafettin okutan, Dr.', 'role': 'CONTACT', 'email': 'serafettin.okutan@gmail.com', 'phone': '+90 (434) 222 01 01', 'phoneExt': '8325'}], 'facility': 'Bitlis Eren University', 'geoPoint': {'lat': 38.40115, 'lon': 42.10784}}], 'centralContacts': [{'name': 'Şerafettin OKUTAN, Dr.', 'role': 'CONTACT', 'email': 'serafettin.okutan@gmail.com', 'phone': '+90 (434) 222 01 01', 'phoneExt': '8325'}], 'overallOfficials': [{'name': 'Şerafettin OKUTAN, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator Bitlis Eren University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bitlis Eren University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University', 'investigatorFullName': 'Serafettin Okutan', 'investigatorAffiliation': 'Bitlis Eren University'}}}}