Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-31 @ 6:57 PM
Study NCT ID:
NCT00788502
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2008-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress Reduction During In Vitro Fertilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014110', 'term': 'Touch'}, {'id': 'D003887', 'term': 'Desensitization, Psychologic'}], 'ancestors': [{'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2008-11-06', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spielberger State Trait Anxiety Inventory', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': '30 days'}, {'measure': 'Infertility Self-Efficacy Scale', 'timeFrame': '30 days'}, {'measure': 'Pregnancy outcome', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine the effect of Healing Touch (HT) on the stress, anxiety, and self-efficacy experiences of women undergoing in vitro fertilization (IVF) in a randomized, controlled design. HT is a gentle, non-invasive form of energy-balancing work that promotes relaxation.', 'detailedDescription': 'Once enrolled, each participant will be randomized to one of three groups: the Healing Touch (HT) treatment arm, the Desensitization Therapy (DT) arm, or the no-intervention arm.\n\nSubjects in Group 1 will receive three, 45-minute HT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 2 will receive three, 45-minute DT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 3 will receive no intervention. Subjects in Group 3 will be offered two HT sessions after completing study participation.\n\nAll subjects and their partners will be asked to complete the Spielberger State Trait Anxiety Inventory (STAI), the Perceived Stress Scale (PSS) and the Infertility Self-Efficacy Scale (ISES) at three time points: 1) baseline 2) one day prior to oocyte retrieval and 3) 5-7 days post embryo transfer. In addition, subjects in all groups will complete a short pre-study questionnaire to assess expectation of therapeutic effect, and subjects in the two intervention groups will complete a short post-study questionnaire to evaluate their treatment experience. Demographic and pregnancy outcome data will be collected for all subjects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:-Age \\<43\n\n* FSH \\<= 14\n* About to enter an IVF cycle at the Stanford Fertility and Reproductive Medicine Center\n* Planning a transfer of their own fresh embryos during this cycle\n* Speak and read English fluently\n* Not planning to use concomitant energy work interventions (HT, Reiki, QiGong, acupuncture)during the IVF cycle.'}, 'identificationModule': {'nctId': 'NCT00788502', 'briefTitle': 'Stress Reduction During In Vitro Fertilization', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Stress Reduction During In Vitro Fertilization', 'orgStudyIdInfo': {'id': 'SU-11052008-1334'}, 'secondaryIdInfos': [{'id': '15402', 'type': 'OTHER', 'domain': 'Stanford University IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healing Touch', 'description': 'Healing Touch (HT) is a gentle form of energy balancing work that promotes relaxation. Subjects in this arm will receive three one-hour sessions of Healing Touch during the first two weeks of their IVF cycle.', 'interventionNames': ['Behavioral: Healing Touch']}, {'type': 'EXPERIMENTAL', 'label': 'Desensitization Therapy', 'description': 'Desensitization Therapy is a quasi-desensitization procedure where subjects meet with a therapist and generate a list of stressful thoughts and a list of neutral thoughts. Subjects in this arm will receive three one-hour sessions of Desensitization Therapy during the first two weeks of their IVF cycle.', 'interventionNames': ['Behavioral: Desensitization Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Subjects in this arm will receive no therapeutic intervention.'}], 'interventions': [{'name': 'Healing Touch', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Healing Touch']}, {'name': 'Desensitization Therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Desensitization Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Kathy Turner RN, NP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}