Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-13 @ 7:54 AM
Study NCT ID:
NCT05492058
Status:
COMPLETED
Last Update Posted:
2022-08-08
First Post:
2022-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fetal heart rate, fetal movement', 'timeFrame': '20 minutes', 'description': 'number'}, {'measure': 'Maternal anxiety', 'timeFrame': '20 minutes', 'description': 'STAI State Anxiety Inventory The emotions and behaviors expressed in the State Anxiety Inventory (STAI TX-I) items are answered by marking one of the options such as (1) never, (2) a little, (3) a lot, (4) completely, according to the severity of such experiences. The options in the Anxiety Scale are "almost never"(1), "sometimes"(2), "often"(3), "almost always"(4). Scoring ranges from 1 to 4. In the scale, there are direct or straight and reversed statements. Direct statements indicate negative emotions, reversed statements indicate positive emotions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nursing', 'fetal health', 'women', 'women health'], 'conditions': ['Fetal Heart Failure', 'Fetal Movement Disorder']}, 'descriptionModule': {'briefSummary': 'The research was carried out to determine the effects of tactile stimulation, music listening and virtual reality video watched during the non-stress test on maternal anxiety level and fetal parameters.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Not having any risk factors (pre-eclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy\n* Absence of uterine contraction as a result of NST,\n* No cardiovascular disease diagnosed in the fetus,\n* Being in the 18-49 age group\n\nExclusion Criteria:\n\n* Any complications in pregnancy and fetus\n* Refusal to accept the final test'}, 'identificationModule': {'nctId': 'NCT05492058', 'briefTitle': 'Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Adiyaman University Research Hospital'}, 'officialTitle': 'Effects of Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Lokman Hekim University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'maternal touch', 'description': 'maternal touch', 'interventionNames': ['Other: tactile stimulation group', 'Other: listen music', 'Other: virtual reality group']}, {'type': 'EXPERIMENTAL', 'label': 'music group', 'description': 'music group', 'interventionNames': ['Other: tactile stimulation group', 'Other: listen music', 'Other: virtual reality group']}, {'type': 'EXPERIMENTAL', 'label': 'virtual reality group', 'description': 'virtual reality group', 'interventionNames': ['Other: tactile stimulation group', 'Other: listen music', 'Other: virtual reality group']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'tactile stimulation group', 'type': 'OTHER', 'otherNames': ['maternal touch'], 'description': 'The tactile stimulation group will be asked to touch their own abdomen during the NST procedure.', 'armGroupLabels': ['maternal touch', 'music group', 'virtual reality group']}, {'name': 'listen music', 'type': 'OTHER', 'otherNames': ['music group'], 'description': 'Pregnant women in the music group will listen to a song they want with headphones during the NST procedure.', 'armGroupLabels': ['maternal touch', 'music group', 'virtual reality group']}, {'name': 'virtual reality group', 'type': 'OTHER', 'description': 'Pregnant women in the virtual reality group will be shown a nature walk video with nature sounds (stream, bird, etc.) during the NST procedure.', 'armGroupLabels': ['maternal touch', 'music group', 'virtual reality group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Çankaya', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Lokman hekim University', 'geoPoint': {'lat': 39.9179, 'lon': 32.86268}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adiyaman University Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lokman Hekim University', 'investigatorFullName': 'Didem Kucukkelepce', 'investigatorAffiliation': 'Adiyaman University Research Hospital'}}}}