Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 5:54 PM
Study NCT ID:
NCT00917332
Status:
UNKNOWN
Last Update Posted:
2009-06-10
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Relaxation and Guided Imagery Training on Pain at Childbirth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012119', 'term': 'Respiration'}, {'id': 'D019018', 'term': 'Imagery, Psychotherapy'}], 'ancestors': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-09', 'studyFirstSubmitDate': '2009-06-08', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rating of pain experienced during childbirth on pain VAS', 'timeFrame': 'one time - during hospitalization after childbirth'}], 'secondaryOutcomes': [{'measure': 'rate and the starting time of receiving regional anesthesia (epidural)', 'timeFrame': 'at childbirth'}]}, 'conditionsModule': {'keywords': ['pain', 'childbirth', 'relaxation', 'guided imagery', 'VAS', 'epidural'], 'conditions': ['Pain at Childbirth']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether relaxation and guided imagery techniques are effective in reducing childbirth pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women who carry their first child\n* women that carry only one embryo\n* women who speaks hebrew\n\nExclusion Criteria:\n\n* women who experienced complications in pregnancy.\n* women who planning on having an elective Caesarean section.\n* women who suffer from background systematic condition (such as high-BP, diabetes).\n* women who have psychiatric background.\n* women who take chronic medication that might effect childbirth, woman or baby's health."}, 'identificationModule': {'nctId': 'NCT00917332', 'briefTitle': 'Effects of Relaxation and Guided Imagery Training on Pain at Childbirth', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Effects of Relaxation and Guided Imagery Training on Rate and Time of Receiving Regional Anesthesia (Epidural), and on the Experience of Childbirth', 'orgStudyIdInfo': {'id': '0256-09-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': '55 third trimester women will receive a CD of relaxation and guided imagery (of "safe place"), to practice daily at home until childbirth', 'interventionNames': ['Behavioral: relaxation (breathing and muscles) and guided imagery ("safe place")']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': '55 third trimester women who does not receive the relaxation and guided imagery CD.'}], 'interventions': [{'name': 'relaxation (breathing and muscles) and guided imagery ("safe place")', 'type': 'BEHAVIORAL', 'description': 'intervention group: daily practice of relaxation and guided imagery CD, for a rew weeks, until childbirth.', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'efrat esterkin, MA', 'role': 'CONTACT', 'email': 'efratkin@gmail.com'}, {'name': 'efrat esterkin, MA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'david mankuta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah Ein-Kerem Haspitol', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'efrat esterkin, MA', 'role': 'CONTACT', 'email': 'efratkin@gmail.com'}], 'overallOfficials': [{'name': 'david mankuta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'hadassah ein-kerem - obstetrics and gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'david mankuta MD', 'oldOrganization': 'hadassah ein-kerem - obstetrics and gynecology'}}}}