Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT05807295
Status:
UNKNOWN
Last Update Posted:
2023-04-11
First Post:
2023-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D017028', 'term': 'Caregivers'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'coping with stress', 'timeFrame': 'Change from Baseline level of Coping with stress to 8 weeks (change is being assessed)', 'description': 'The scale is a 23-item self-report measure of anxiety using a 5-point Likert-type scale. The scale does not have a cut-off point. The higher the score obtained from the scale, the better the coping is determined.'}, {'measure': 'Anxiety', 'timeFrame': 'Change from Baseline level of Spielberger State-Trait Anxiety to 8 weeks (change is being assessed)', 'description': 'The scale is a 20-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. The total score obtained from the scale varies between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregivers With a Child Followed up With a Cancer Diagnosis']}, 'referencesModule': {'references': [{'pmid': '38471311', 'type': 'DERIVED', 'citation': 'Ozturk CS, Katikol E. Effect of mHealth-based relaxation program on stress coping and anxiety levels in mothers of children with cancer: A randomized controlled study. Patient Educ Couns. 2024 Jun;123:108247. doi: 10.1016/j.pec.2024.108247. Epub 2024 Mar 11.'}]}, 'descriptionModule': {'briefSummary': "This research will be carried out to determine the effect of the relaxation program applied to the caregivers of children followed by the diagnosis of cancer on the levels of caregivers' anxiety and coping with stress. The research will be conducted in a single-blind parallel-group randomized controlled trial design. A relaxation program including progressive muscle relaxation exercises will be applied to caregivers. The application will be carried out by sending muscle relaxation videos and videos for relaxation to mothers. The relaxation program is planned to last approximately 6 weeks", 'detailedDescription': 'In this study, a relaxation program will be applied to mothers who have a child followed up with a cancer diagnosis. The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications. Caregivers will then be asked to perform the treatments each week. Coping with Stress and State-Trait Anxiety Scale will be used at the beginning and end of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* The child has received cancer treatment for at least two months,\n* Those who have internet access on their smartphone or computer\n* Those who can continue the work for six weeks (doing progressive relaxation exercises at least 2 times a week)\n\nExclusion Criteria:\n\n* Those whose children/caregivers are in the terminal period,\n* Those whose child/caregiver has not received chemotherapy treatment,\n* Those who take medication for anxiety or use one of the complementary medicine approaches.'}, 'identificationModule': {'nctId': 'NCT05807295', 'briefTitle': 'The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.', 'orgStudyIdInfo': {'id': '1503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'caregivers receiving a relaxation program', 'interventionNames': ['Other: Relaxation Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'the group that did not receive any training'}], 'interventions': [{'name': 'Relaxation Program', 'type': 'OTHER', 'otherNames': ['The relaxation program for caregivers'], 'description': "The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Videos will be sent to caregivers' social media accounts. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gazi University', 'investigatorFullName': 'Çiğdem Sarı Öztürk', 'investigatorAffiliation': 'Gazi University'}}}}