Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-05 @ 1:51 PM
Study NCT ID:
NCT06626958
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2024-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The researcher performing the statistical analysis will not know which data is the experimental group and which is the control group.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled experimental trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-15', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lapor Pain', 'timeFrame': 'First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor', 'description': 'The VAS scale will be used to evaluate the level of labor pain in the intervention and control groups. VAS is scored from 1 to 10. As the score obtained from the scale increases, it shows that the labor pain also increases. After the pre-test and the intervention, it is expected that the pain will change in the interventionl group and the VAS score will change.Measurement will begin when cervical dilation is 3-4 cm, and the final test will be performed and completed when cervical dilation is approximately 7-8 cm. This will take approximately 10-12 hours.'}, {'measure': 'Labor Comfort', 'timeFrame': 'First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor', 'description': 'The minimum score on the scale is 9 and the maximum score is 45. It indicates that as the score value of the scale increases, comfort increases, and as the score value decreases, comfort decreases.The minimum score on the scale is 9 and the maximum score is 45. As the score of the scale increases, it indicates that comfort increases, and as the score decreases, comfort decreases. The birth comfort scale will be applied when the cervical dilatation reaches 7-8 cm. It is expected that the birth comfort will be higher in the intervention group than in the experimental group. The scale will be applied within the first hour when the cervical dilatation reaches 7-8 cm.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Active phase of labor,', 'stress ball,', 'labor pain,', 'labor comfort'], 'conditions': ['Labor Pain', 'Birth Order', 'Stress']}, 'descriptionModule': {'briefSummary': 'The aim of the clinical trial is to examine the effect of a stress ball applied to pregnant women during the active phase of labor on labor pain and labor comfort. The effect of the stress ball used in the experimental group on labor pain and labor comfort will be evaluated. The stress ball applied to pregnant women during the active phase of labor minimizes labor pain and increases labor comfort H 0: The stress ball used during the active phase of labor has no effect on labor pain and labor comfort.\n\nH 1: The stress ball used during the active phase of labor increases labor pain and labor comfort.\n\nThe researchers will monitor the pregnant women from the time the cervical dilation is 3-4 cm (from the active phase of labor) until the cervical dilation is 8-9 cm and the experimental group will be asked to use the stress ball. Routine application will be made to the control group. The pain during labor of the experimental and control groups will be evaluated with the VAS scale. After the birth, the labor comfort scale will be applied to measure labor comfort.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Labor pain and labor comfort will be evaluated.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vaginal birth\n* Pregnant women between the ages of 18-40\n\nExclusion Criteria:\n\n* Risky pregnancy'}, 'identificationModule': {'nctId': 'NCT06626958', 'briefTitle': 'Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect of the Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort', 'orgStudyIdInfo': {'id': 'SOZTURK0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vsisual Analog Scale (VAS)', 'description': 'The VAS scale will be used to evaluate the level of labor pain in the intervention and control groups.', 'interventionNames': ['Behavioral: Stress Ball']}, {'type': 'EXPERIMENTAL', 'label': 'Labor Comfort Scale', 'description': 'The birth comfort scale will evaluate the birth comfort of women in the intervention and control groups during birth.', 'interventionNames': ['Behavioral: Stress Ball']}], 'interventions': [{'name': 'Stress Ball', 'type': 'BEHAVIORAL', 'description': 'Stress Ball app', 'armGroupLabels': ['Labor Comfort Scale', 'Vsisual Analog Scale (VAS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Muş', 'state': 'Merkez', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'banu Bayram, midwife', 'role': 'CONTACT', 'email': 'musdh.bsh@saglik.gov.tr', 'phone': '04362120670'}, {'name': 'Mihriban Elmas, Midwife', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Muş State Hospital Birth Hall', 'geoPoint': {'lat': 38.73163, 'lon': 41.48482}}], 'centralContacts': [{'name': 'Sibel ÖZTÜRK, PhD', 'role': 'CONTACT', 'email': 'sblsbl0606@gmail.com', 'phone': '+90442231', 'phoneExt': '4063'}], 'overallOfficials': [{'name': 'Mihriban Elmas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'mihriban.elmas@icloud.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sibel ÖZTÜRK', 'investigatorAffiliation': 'Ataturk University'}}}}