Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-28 @ 2:49 AM
Study NCT ID:
NCT03905395
Status:
UNKNOWN
Last Update Posted:
2019-04-05
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditation and Mindfulness for Recurrent Pregnancy Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-01-27', 'releaseDate': '2022-04-26'}, {'resetDate': '2023-12-01', 'releaseDate': '2023-02-21'}], 'estimatedResultsFirstSubmitDate': '2022-04-26'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized trial where women in an experimental arm will receive 3 times a three hour work shop with introduction to meditation and mindfulness during a 7 week period. Women in the other arm will have no intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-04', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': '7 weeks', 'description': 'Change from baseline to 7 weeks after date of first course day measured by Perceived Stress Scale. PSS is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress). The higher score the more stress.'}, {'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': '12 months', 'description': 'Change from baseline to 12 months after date of first course day measured by the Perceived Stress Scale. PSS is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress). The higher score the more stress.'}], 'secondaryOutcomes': [{'measure': 'COMPI Fertility Problem Stress Scale', 'timeFrame': '7 weeks', 'description': 'Change from baseline to 7 weeks after date of first course day using the COMPI Fertility Problem Stress Scale.\n\nThe COMPI Fertility Problem Stress Scale is a validated scale measuring the impact of RPL on the woman and her interpersonal relationships. Two questions asking if the experience of RPL has been stressful for the woman with five answering options. Followed by seven sub questions asking how big a load RPL has been for the patients interpersonal life with four answering options. The lower the score the higher stress.'}, {'measure': 'Marital Benefit Scale', 'timeFrame': '7 weeks', 'description': 'Change in marital benefit from baseline to 7 weeks after date of first course day using the COMPI Marital Benefit Scale.\n\nThe COMPI Marital Benefit Scale has two questions asking what the RPL have mattered for their relationship/mariage:\n\nFive options to answer: totally disagree, partly disagree, neither agree or disagree, partly agree, totally agree. Answering "Totally agree" on both questions is defined as a high marital benefit.'}, {'measure': 'COMPI Fertility Problem Stress Scale', 'timeFrame': '12 months', 'description': 'Change in fertility problem stress from baseline to 12 months after date of first course day using the COMPI Fertility Problem Stress Scale.\n\nThe COMPI Fertility Problem Stress Scale is a validated scale measuring the impact of RPL on the woman and her interpersonal relationships. Two questions used to assess how big a impact RPL has for the patient with five answering options. Followed by seven sub questions asking how big a load RPL has been for the patients interpersonal life with four answering options. The lower the score the higher stress.'}, {'measure': 'Marital Benefit', 'timeFrame': '12 months', 'description': 'Change in marital benefit from baseline to 12 months after date of first course day using the COMPI Marital Benefit Scale.\n\nThe COMPI Marital Benefit Scale has two questions asking what the RPL have mattered for their relationship/mariage:\n\nFive options to answer: totally disagree, partly disagree, neither agree or disagree, partly agree, totally agree. Answering "Totally agree" on both questions is defined as a high marital benefit.'}, {'measure': 'Major Depression Index (MDI)', 'timeFrame': '12 months', 'description': 'Change in depression score from baseline to 12 months after date of first course day. Major Depression Index is a validated self-rating depression scale, which is used both clinically and in epidemiological studie. The 6-point Likert scale ranges from 0 (no depression) to 50 (extreme depression).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meditation', 'mindfulness', 'pregnancy loss', 'stress'], 'conditions': ['Recurrent Pregnancy Loss']}, 'descriptionModule': {'briefSummary': "In the Danish Recurrent Pregnancy Loss Unit in Rigshospitalet in Copenhagen recurrent pregnancy loss (RPL) is defined as three og more consecutive pregnancy losses in accordance with current European guidelines.\n\nRPL affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth.\n\n42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8 % of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood.\n\nThe study is a RCT including 62 patients - 31 in each arm. One arm will be taught in meditation and mindfulness three courses over a 7 week period. This group will also do meditation every day for 7 weeks. The other arm will have no intervention.\n\nThis study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen. Furthermore this study will investigate if there's a marital benefit such as reinforcement in their relationsship from practicing meditation and mindfulness.\n\nThere is no previous study that has investigated meditation and mindfulness for RPL.\n\nThis study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients.", 'detailedDescription': "The loss of a desired pregnancy is a significant negative life event associated with grief comparable to the grief after a peri- or neonatal death. Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to have children. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth.\n\n42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8% of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood.\n\nThis study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen.\n\nFurthermore this study will investigate if there's a marital benefit from practicing meditation and mindfulness. The investigators will use four different scales to measure the participants stress, depression, marital benefit and fertility stress. Also the investigators will measure the participants before and after the intervention and 12 months after.\n\nAll participants will have to complete:\n\n1. Major Depression Index, a validated self-rating depression scale, which is used both clinically and in epidemiological studie. The 6-point Likert scale ranges from 0 (no depression) to 50 (extreme depression).\n2. Perceived Stress Scale, which is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress).\n3. The COMPI Fertility Problem Stress Scale, a validated scale measuring the impact of RPL on the woman and her interpersonal relationships.\n4. The COMPI Marital Benefit Scale measuring if RPL has reinforced the couples mariage/relationship.\n\nThe investigators assume that meditation and mindfulness can improve the quality of life for the RPL patients and their coping strategies. It's the investigators purpose to contribute with new knowledge in this area for current and future patients.\n\nThe RPL Unit in Rigshospitalet doesn't have any psychological support apart from ordinary attention from the nurses. This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients, which is in high demand."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Based on biological sex', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with RPL\n* Speaking, reading and understanding Danish\n* Have given a written consent\n* Have a male partner\n* Have a stress score \\> 16 points on Perceived Stress Scale\n\nExclusion Criteria:\n\n* If the patient is pregnant on inclusion day\n* If the patient already is practing meditation and mindfulness\n* If the patient has a depression\n* If the patient develops a depression after inclusion in either arm'}, 'identificationModule': {'nctId': 'NCT03905395', 'briefTitle': 'Meditation and Mindfulness for Recurrent Pregnancy Loss', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Meditation and Mindfulness for Recurrent Pregnancy Loss', 'orgStudyIdInfo': {'id': 'H-18038456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Meditation and mindfulness intervention', 'description': 'Women in the intervention arm will 3 times receive a three hours work shop with introduction to meditation and mindfulness over a 7 week period from a certified meditation instructor. Questionnaires before and after the intervention.', 'interventionNames': ['Behavioral: Meditation and mindfulness']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Women in the no intervention arm will receive no introduction to meditation and mindfulness - only questionnaires at the same time as the intervention group receives questionnaires.'}], 'interventions': [{'name': 'Meditation and mindfulness', 'type': 'BEHAVIORAL', 'description': 'Women in the intervention arm will 3 times receive a three hours work shop with introduction to meditation and mindfulness over a 7 week period from a certified meditation instructor. Questionnaires before and after the intervention.', 'armGroupLabels': ['Meditation and mindfulness intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Østerbro', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henriette Svarre Nielsen, MD. MDSc', 'role': 'CONTACT', 'email': 'Henriette.Svarre.Nielsen@regionh.dk', 'phone': '+4535458486'}, {'name': 'Karen Kirchheiner Jensen, Nurse', 'role': 'CONTACT', 'email': 'Karen.Henriette.Jensen@regionh.dk', 'phone': '+4535458486'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Henriette Svarre Nielsen, MD, DMSc', 'role': 'CONTACT', 'email': 'Henriette.Svarre.Nielsen@regionh.dk', 'phone': '+4535458486'}, {'name': 'Karen Henriette Kirchheiner Jensen, Nurse', 'role': 'CONTACT', 'email': 'Karen.Henriette.jensen@regionh.dk', 'phone': '+4535458486'}], 'overallOfficials': [{'name': 'Karen Kirchheiner Jensen, Nurse', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henriette Svarre Nielsen, MD, DMSc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Henriette Svarre Nielsen, MD, DMSc, Consultant, Head of Recurrent Pregnancy Loss Unit, Associate Professor, Rigshospitalet, Denmark', 'investigatorFullName': 'Henriette Svarre Nielsen, MD, DMSc', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-26', 'type': 'RELEASE'}, {'date': '2023-01-27', 'type': 'RESET'}, {'date': '2023-02-21', 'type': 'RELEASE'}, {'date': '2023-12-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Henriette Svarre Nielsen, MD, DMSc, Henriette Svarre Nielsen, MD, DMSc, Consultant, Head of Recurrent Pregnancy Loss Unit, Associate Professor, Rigshospitalet, Denmark, Rigshospitalet, Denmark'}}}}