Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-01 @ 3:26 PM
Study NCT ID:
NCT07060768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mandala Coloring on Perinatal Grief and Psychological Resilience Levels in Women Experiencing Perinatal Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-06-21', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perinatal Grief', 'timeFrame': '1st day to 10th day', 'description': 'Perinatal Grief will be assessed via Perinatal Grief Scale. The scale is a 5-point Likert-type scale and responses range from "strongly agree to strongly disagree". The scale includes three sub-dimensions: "active grief", "difficulty coping" and "hopelessness". The total number of items in the scale is 32. Items 11 and 32 of the scale have a positive sentence structure. These items are answered in reverse. While the total grief score that can be obtained from the scale varies between 32-160, the scores that can be obtained for each sub-dimension seperately.\n\nAs the total perinatal grief score and the total score obtained from the sub-dimensions increase, it is determined that the individual\'s grief level is higher.'}, {'measure': 'Perinatal Grief Intensity', 'timeFrame': '1st day to 10th day', 'description': 'Will be assessed via Perinatal Grief Intensity Scale. The scale consists of 14 items, rated on a 4-point Likert-type scale from strongly agree to strongly disagree, and three sub-dimensions: "reality", "confrontation with others", and "adaptation". The scale contains both positive and negative expressions. Therefore, items 1, 2, 3, and 6 are evaluated as reverse items in the scoring of the scale. When calculating the scores of the sub-dimensions, the score obtained from each item is added up and divided by the number of items in the sub-dimension. Thus, a total score between 1 and 4 is obtained from each sub-dimension. The following formula is used for the total score:\n\n3.08 + (0.41 x reality sub-dimension mean score) - (0.2 x confrontation sub-dimension mean score) - (0.15 x harmony sub-dimension mean score) The score that can be obtained from the scale varies between 2.09 - 4.37. It is predicted that the intensity of grief that will be experienced increases as the score increases'}], 'secondaryOutcomes': [{'measure': 'Resilience', 'timeFrame': '1st day and 10th day', 'description': "Will be assessed via Resilience Scale for Adults. The scale has a schematic evaluation with five boxes. The scale consists of six factors titled 'Self-perception, 'Future perception,' 'Structural style,' 'Social competence,' 'Family harmony,' and 'Social resources,' and contains a total of 33 items. Cronbach's alpha coefficient of the sub-dimensions of the scale varies between 0.75-0.86"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perinatal loss', 'resilience', 'perinatal grief'], 'conditions': ['Perinatal Loss']}, 'referencesModule': {'references': [{'pmid': '9773366', 'type': 'BACKGROUND', 'citation': 'Hutti MH, dePacheco M, Smith M. A study of miscarriage: development and validation of the Perinatal Grief Intensity Scale. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):547-55. doi: 10.1111/j.1552-6909.1998.tb02621.x.'}, {'type': 'BACKGROUND', 'citation': 'Kones MO, Kaydırak MM, Aslan E, Yildiz H. The Perinatal Grief Scale (33-item short version): validity and reliability of the Turkish version. Anadolu Psikiyatri Derg. 2017; 18(3): 231-236. doi:10.5455/apd.234509.'}, {'pmid': '3407734', 'type': 'BACKGROUND', 'citation': 'Toedter LJ, Lasker JN, Alhadeff JM. The Perinatal Grief Scale: development and initial validation. Am J Orthopsychiatry. 1988 Jul;58(3):435-49. doi: 10.1111/j.1939-0025.1988.tb01604.x.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate if mandala colouring helps to decrease grief symptoms and increase resilience in women who experienced perinatal loss.\n\nThe main questions are:\n\nDoes mandala coloring decrease perinatal grief symptoms? Does mandala coloring increase resilience?\n\nResearchers will compare mandala coloring intervention with standard perinatal loss nursing care to evaluate if mandala coloring works to decrease grief symptoms.\n\nParticipants will:\n\nAnswer some questionnaires and scales, and do mandala coloring at least for 20 minutes for 10 days after perinatal loss experience.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Cisgender people identify with the gender that aligns with the sex they were assigned at birth', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced perinatal loss (neonatal death, fetal death, abortion) within the last six weeks\n\nExclusion Criteria:\n\n* Serious psychological problem that requires intervention with the recommendation of a psychiatrist, such as having a previous mental disorder or use of antidepressants.\n* Practicing alternative methods such as yoga, meditation, acupuncture'}, 'identificationModule': {'nctId': 'NCT07060768', 'briefTitle': 'The Effect of Mandala Coloring on Perinatal Grief and Psychological Resilience Levels in Women Experiencing Perinatal Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of Yalova'}, 'officialTitle': 'The Effect of Mandala Coloring on Perinatal Grief and Psychological Resilience Levels in Women Experiencing Perinatal Loss: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EBYalova'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This arm will have mandala coloring intervention', 'interventionNames': ['Other: Mandala Coloring']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This arm will not receive any intervention'}], 'interventions': [{'name': 'Mandala Coloring', 'type': 'OTHER', 'description': 'Mandala coloring at least 20 minutes each day. Totally 10 days intervention', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Elif Balkan, PhD Student', 'role': 'CONTACT', 'email': 'elif.balkan@yalova.edu.tr', 'phone': '+905423513125'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared publicly due to ethical restrictions. But authors may share IPD with researchers who reach out to the authors for data sharing with necessary reasons'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Yalova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Elif Balkan', 'investigatorAffiliation': 'University of Yalova'}}}}