Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:19 AM
Study NCT ID:
NCT07330557
Status:
COMPLETED
Last Update Posted:
2026-01-09
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect Of The Labour Hopscotch On The Birth Process And Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['PARTICIPANT'], 'maskingDescription': 'No parties are masked in this study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A parallel design was chosen to compare the effects of the labor hopscotch program with standard intrapartum care. Participants are randomly assigned to either the intervention or control group, and outcomes are measured concurrently in both groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-29', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-29', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Satisfaction Score Measured by a Validated Satisfaction Scale', 'timeFrame': 'Within 24 hours postpartum', 'description': 'Maternal satisfaction will be assessed using a validated satisfaction scale. Total scores will be calculated according to the scale guidelines, with higher scores indicating greater maternal satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Labor hopscotch', 'physiologic vaginal birth', 'labor pain', 'labor duration,', 'birth satisfaction', 'non-pharmacological intrapartum care'], 'conditions': ['Labor Duration', 'Labor Bain', 'and Birth Satisfaction During Physiologic Vaginal Birth']}, 'referencesModule': {'references': [{'pmid': '36132188', 'type': 'RESULT', 'citation': "Carroll L, Thompson S, Coughlan B, McCreery T, Murphy A, Doherty J, Sheehy L, Cronin M, Brosnan M, O'Brien D. 'Labour Hopscotch': Women's evaluation of using the steps during labor. Eur J Midwifery. 2022 Sep 9;6:59. doi: 10.18332/ejm/152492. eCollection 2022."}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the effect of the Labor Hopscotch exercise on the birth process and maternal satisfaction. The study will be conducted as a randomized controlled trial at a tertiary-level maternity unit. Eligible pregnant women will be recruited during the active phase of labor and randomly assigned to either the intervention group or the control group.\n\nParticipants in the intervention group will receive the Labor Hopscotch exercise program during labor in addition to standard intrapartum care. The control group will receive standard intrapartum care only. The Labor Hopscotch exercise program consists of structured physical movements adapted to the stages of labor and is implemented under the supervision of trained healthcare professionals.\n\nData will be collected using standardized data collection forms, obstetric records, and validated measurement tools. Information related to sociodemographic characteristics, obstetric history, labor characteristics, and maternal experiences during labor will be recorded. The study is conducted in accordance with ethical principles and relevant institutional guidelines.', 'detailedDescription': 'This study aims to evaluate the effect of the Labor Hopscotch exercise on the labor process and maternal experience. The study is designed as a randomized controlled trial including eligible pregnant women. Participants will be allocated to an intervention group or a control group, and predefined outcomes will be assessed using standardized procedures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '• Primiparous pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparous pregnant women with cervical dilation between 3cm and 5cm, expected to have a vaginal delivery and admitted to the delivery room,\n* Pregnant women aged 18-35,\n* Pregnant women with gestational age between 37-42 weeks,\n* Able to speak and understand Turkish, and\n* At least primary school graduates (as the scales will be completed using the self-report method) will be included.\n* Pregnant women without a history of mental or physical health problems,\n* Pregnant women without a history of high-risk pregnancy.'}, 'identificationModule': {'nctId': 'NCT07330557', 'acronym': 'Labor Hopscotc', 'briefTitle': 'The Effect Of The Labour Hopscotch On The Birth Process And Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Effect of the Labour Hopscotch Method on the Labor Process and Maternal Satisfaction: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023/46'}, 'secondaryIdInfos': [{'id': '2023/46', 'type': 'OTHER', 'domain': 'Adnan Menderes University Faculty of Health Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Labor Hopscotch Program Group', 'description': 'Participants undergo the Labor Hopscotch Exercise Program during the first stage of labor. This program is a non-pharmacological, behavioral intervention that encourages active movement. The exercises aim to shorten labor duration, reduce pain, and increase birth satisfaction. The program is performed under the supervision of trained healthcare professionals and provides ongoing intrapartum support.', 'interventionNames': ['Behavioral: Labor Hopscotch Exercise Program Group', 'Other: Standard Intrapartum Care']}, {'type': 'OTHER', 'label': 'Standard Intrapartum Care Group → Control', 'description': 'Participants received standard intrapartum care. This intervention included routine birth practices and care procedures. This group, which did not include any special exercises or additional interventions, served as the control group.', 'interventionNames': ['Behavioral: Labor Hopscotch Exercise Program Group', 'Other: Standard Intrapartum Care']}], 'interventions': [{'name': 'Labor Hopscotch Exercise Program Group', 'type': 'BEHAVIORAL', 'description': 'Throughout labor, active positions, movements, breathing exercises, and recordings are utilized, along with the hopscotch steps.\n\nGuided by a trained midwife/healthcare professional.\n\nApplied throughout the latent and active phases.\n\nPurpose: To reduce pain, facilitate labor progression, and minimize interventions.', 'armGroupLabels': ['Labor Hopscotch Program Group', 'Standard Intrapartum Care Group → Control']}, {'name': 'Standard Intrapartum Care', 'type': 'OTHER', 'description': "The institution's routine standard maternity care protocol\n\nNonpharmacological or pharmacological comfort measures per standard care\n\nIncludes routine clinical practices of healthcare professionals\n\nHopscotch program is not implemented", 'armGroupLabels': ['Labor Hopscotch Program Group', 'Standard Intrapartum Care Group → Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Aydın Kadın ve Çocuk Hastalıkları Hastanesi', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be made available to qualified researchers upon reasonable request after publication of the main study results. Data will be shared through a secure data repository, following ethical and privacy regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctoral student', 'investigatorFullName': 'Pirozhan', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}