Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT05283460
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2022-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mandala Activity on Life Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'participants will not known wich type of group'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was designed as a randomized controlled prospective double-blind clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-18', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Life satisfaction scale mean', 'timeFrame': 'up to 3 weeks', 'description': 'Average score from life satisfaction scale ( Minimum score; 5, Maximum score;25)'}], 'secondaryOutcomes': [{'measure': 'Life satisfaction scale mean', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Average score from life satisfaction scale( Minimum score;5 , Maximum score;25)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gynecologic Cancer', 'Life satisfaction', 'Mandala'], 'conditions': ['ART', 'Life Satisfaction', 'Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': 'This study aimed to determine the effect of mandala activity on life satisfaction of women receiving chemotherapy for gynecological cancer.', 'detailedDescription': 'Data will be collected using the descriptive information form and the Life Satisfaction Scale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Because gynecological cancers occur only in women', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Receiving chemotherapy\n* No communication problems\n* Having at least 6 months of cancer diagnosis\n* Being in Stage 2 and Stage 3 of the disease\n\nExclusion Criteria:\n\n* Having a medical device (IV catheter, etc.) or physical symptoms (vision problems, Parkinson's disease, etc.) that may prevent mandala drawing.\n* Being in Stage 1 and Stage 4 of the disease."}, 'identificationModule': {'nctId': 'NCT05283460', 'briefTitle': 'The Effect of Mandala Activity on Life Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'Munzur University'}, 'officialTitle': 'The Effect of Mandala Activity on Life Satisfaction of Women Receiving Chemotherapy for Gynecological Cancer: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'munzur u'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mandala', 'description': 'As in the case of previous studies, to prevent confusion and make the mandala drawing process easier, a few videos describing what a mandala is were shown to the patients, and information was provided. Next, each patient was given a set of felt-tip pens (in 24 different colors) and ready-to-use mandala papers, and they were asked to complete the mandala activity. The patients were given empty mandala books with enough pages for them to draw mandalas every day, they were asked to perform the mandala activity regularly in a time interval of their own choice every day, and whether they performed the activity was checked daily without them noticing (so that they would not have the feeling of being checked on or inspected).', 'interventionNames': ['Behavioral: mandala']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it.'}], 'interventions': [{'name': 'mandala', 'type': 'BEHAVIORAL', 'otherNames': ['control group'], 'description': 'The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it.', 'armGroupLabels': ['mandala']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62002', 'city': 'Tunceli', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Munzur University', 'geoPoint': {'lat': 39.09921, 'lon': 39.54351}}], 'overallOfficials': [{'name': 'Nursel A Dal, Assist Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Munzur Ünivesitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Munzur University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nursel Alp Dal', 'investigatorAffiliation': 'Munzur University'}}}}