Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-28 @ 9:13 AM
Study NCT ID:
NCT05312502
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2022-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The sample size was 106 pregnant women, 53 in each group, with a known score using the G\\*Power 3.1.7 program (intervention group=29.19±5.86-control group=26.51±5.13) with 85% power, 0.48 effect size and 0.15 error. was calculated as. Considering data loss, it is planned to reach 10% more pregnant women. Intervention group=57, control group=54 pregnants, and the study was terminated. The women were divided into two groups using the random numbers table in the simple random sampling method. Single blinding was performed on the women participating in the study. However, in order to prevent bias, the researcher who collected the data gave codes to the questionnaire forms of the pregnant women.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-04-02', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Introductory Information Form', 'timeFrame': 'pre-intervention', 'description': 'The form consisting of 13 questions was prepared by the researcher in order to describe the sociodemographic characteristics and current health status of women.'}, {'measure': 'Birth Process Follow-up Form', 'timeFrame': 'during the intervention', 'description': 'It was created by the researcher in order to obtain information about the progress of birth and the characteristics of the fetus during the birth process of the pregnant. In the form, there are questions including the hour and subsequent follow-up hours when the vaginal opening is 4 cm, dilatation, fetal heartbeat, whether there is oxytocin administration, the duration and frequency of contractions, and the characteristics of the amniotic fluid.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'during the intervention', 'description': 'It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). A 10 cm vertical form was used in the study. Pain level was evaluated with VAS during each follow-up of the pregnant woman.'}, {'measure': 'Birth Satisfaction Scale-Short Form (DME-F)', 'timeFrame': 'in the first hour in postpartum period', 'description': 'The short form of the scale was revised by Martin et al. in 2016 to evaluate the birth satisfaction levels of women (Martin et al., 2016). The Turkish validity and reliability study was conducted by Serhatlıoğlu et al. in 2018 (Göncü Serhatlıoğlu et al., 2018). The scale consists of 10 items and a minimum of 0 and a maximum of 40 points can be obtained. The items of the scale are in a 5-point Likert type and are scored as Strongly agree (4 points)-Strongly Disagree (0 points).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Birth ball', 'birth satisfaction', 'pain', 'midwifery care'], 'conditions': ['Pain', 'Labor Pain', 'Satisfaction']}, 'referencesModule': {'references': [{'pmid': '37408298', 'type': 'DERIVED', 'citation': 'Kilic S, Dereli Yilmaz S. Virtual Reality Headset Simulating a Nature Environment to Improve Health Outcomes in Pregnant Women: A Randomized-Controlled Trial. Clin Nurs Res. 2023 Nov;32(8):1104-1114. doi: 10.1177/10547738231184923. Epub 2023 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'H0: There is no difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during labor.\n\nH1: There is a difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during the birth process.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '47 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the consent of the pregnant women to participate in the study,\n* have signed the informed consent form,\n* be over the age of 18,\n* Vaginal opening was determined as 4 cm\n\nExclusion Criteria:\n\n* Having a psychologically diagnosed disorder\n* Pregnant women diagnosed with risky pregnancy'}, 'identificationModule': {'nctId': 'NCT05312502', 'briefTitle': 'Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0000-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Birth Ball', 'description': "In the second stage, the birth ball application was made and followed. Pregnant women with a vaginal opening of 4 cm admitted to the delivery room were instructed to sit on the delivery ball for a total of 30 minutes. A stopwatch clock was used to determine these 30 minutes. The pregnant woman was not asked to sit on the ball all the time, and she could take a break for rest or other needs. The birth ball, which is suitable for women's use, was preferred in 45 cm dimensions, and the pilates circle was used as a stabilizer. Under the supervision of the researcher, the pregnant women sat upright on the ball and began to rock back and forth. Meanwhile, the researcher held the pregnant woman's hand. In order for the pregnant woman not to lose her balance, the birth ball was placed on a pilates circle and she was supported by the researcher in making the movements.", 'interventionNames': ['Other: Birth Ball']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'A routine care was performed.'}], 'interventions': [{'name': 'Birth Ball', 'type': 'OTHER', 'description': 'During labour, the pregnant woman was positioned using a birth ball.', 'armGroupLabels': ['Experimental: Birth Ball']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asistant Prof. Dr.', 'investigatorFullName': 'Yasemin ERKAL AKSOY', 'investigatorAffiliation': 'Selcuk University'}}}}