Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT04610151
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2020-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Guided Imagery on Postoperative Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019018', 'term': 'Imagery, Psychotherapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study was conducted with patients undergoing lower extremity operations between April 2018 and May 2019 at the Necip Fazıl City Hospital (Kahramanmaraş, Turkey) as a pretest-posttest study with a quasi-experimental design and a control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-10-29', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A mean total score on the Visual Analogue Scale (VAS)', 'timeFrame': 'first week', 'description': 'A mean total score on the VAS of four and above indicates postoperative pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient', 'Postoperative', 'Pain', 'Visual Analogue Scale', 'Guided Imagery'], 'conditions': ['Healthy', 'Nursing Caries']}, 'descriptionModule': {'briefSummary': 'This study was conducted to determine the effects of guided imagery on postoperative pain management.', 'detailedDescription': 'The sample of the study consisted of 60 patients (30 in the experiment and 30 in the control groups) undergoing lower extremity operations at the orthopedics clinics of the Kahramanmaras Necip Fazil City Hospital. The study was conducted between April and September 2018.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients at and over the age of 18\n* Patients who were able to speak Turkish\n* Patients who received spinal anesthesia\n\nExclusion Criteria:\n\n* Patients who had not previously used guided imagery\n* Patients any disease that could cause pain outside the surgery'}, 'identificationModule': {'nctId': 'NCT04610151', 'briefTitle': 'The Effects of Guided Imagery on Postoperative Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'Dicle University'}, 'officialTitle': 'The Effects of Guided Imagery on Postoperative Pain Management: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LZA2018/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guided Imagery', 'description': 'Guided Imagery Intervention:The pretest data of the patients with a pain score of 4 or higher according to VAS were collected. Afterwards, the experiment group patients were applied guided imagery.', 'interventionNames': ['Other: guided imagery']}, {'type': 'NO_INTERVENTION', 'label': 'No-Reflexology Application , control group.', 'description': 'No intervention was applied on the control group patients.'}], 'interventions': [{'name': 'guided imagery', 'type': 'OTHER', 'description': 'Guided Imagery CD: A guided imagery CD was prepared by a web designer with the recommendations of the researcher to include relaxing, soft and slow-paced, mixed nature sounds and photographs towards reducing pain in lower extremity surgical operation patients. The directives used for guidance, the audio recordings created as a result of literature review and the video lasted for 13 minutes (', 'armGroupLabels': ['Guided Imagery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21280', 'city': 'Diyarbakır', 'state': 'Sur', 'country': 'Turkey (Türkiye)', 'facility': 'Leyla ZENGİN AYDIN', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dicle University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Leyla ZENGİN AYDIN', 'investigatorAffiliation': 'Dicle University'}}}}