Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:10 PM
Study NCT ID:
NCT07451834
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress Ball Intervention During Active Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-28', 'studyFirstSubmitQcDate': '2026-02-28', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity During Active Labor', 'timeFrame': 'Measured at 5 cm, 6 cm, 8 cm, and 10 cm cervical dilatation during active labor.', 'description': 'Visual Analogue Scale (VAS) The VAS was used to assess perceived pain intensity. The scale consists of a 10 cm (100 mm) horizontal line, anchored by "no pain" (0 mm) at one end and "the worst pain imaginable" (100 mm) at the other. Participants were asked to indicate their level of pain by drawing a line, placing a mark, or indicating a point along the scale. The distance from the starting point to the marked point was measured in millimetres, and analyses were conducted on a 0-100 mm scale. On the VAS, scores between 0-44 mm indicate mild pain, 45-74 mm indicate moderate pain, and 75-100 mm indicate severe pain (Jensen, 2003). Assessments were performed hourly throughout the active phase of labour.'}], 'secondaryOutcomes': [{'measure': 'Childbirth Comfort Level', 'timeFrame': 'Baseline (active phase onset) and within 24 hours after birth.', 'description': "Childbirth Comfort Scale Based on Kolcaba's Comfort Theory, the scale was developed by Schuiling et al. (Schuiling et al., 2011), and its Turkish validity and reliability were established by Potur et al. (Coşkuner Potur et al., 2015). The instrument consists of nine items rated on a 5-point Likert scale and comprises three subdimensions: physical, psychospiritual, and environmental comfort. Before calculating the total score, items 5, 7, and 8 must be reverse-coded. The total score ranges from 9 to 45, with higher scores indicating higher levels of comfort and lower scores reflecting lower levels of comfort. In the Turkish validity and reliability study, the Cronbach's alpha coefficient was reported as 0.75 (Coşkuner Potur et al., 2015). In the present study, the Cronbach's alpha coefficient was likewise calculated as 0.75. In this research, the scale was administered as a pre-test and as a post-test within 24 hours after childbirth."}, {'measure': 'Self-Efficacy Scale', 'timeFrame': 'Baseline (active phase onset) and within 24 hours after birth.', 'description': "Self-Efficacy Scale Developed by Sherer et al. (Sherer et al., 1982) to assess self-efficacy beliefs-one of the core constructs of Social Cognitive Theory-the scale was adapted into Turkish by Yıldırım and İlhan (Yıldırım \\& İlhan, 2010), who established its validity and reliability. The instrument consists of 17 items rated on a 5-point Likert scale. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are reverse-scored. The total score ranges from 17 to 85, with higher scores indicating stronger self-efficacy beliefs. Although the scale identifies three subdimensions-initiation, persistence in the face of adversity (non-withdrawal), and maintenance of effort/insistence-it is recommended that the instrument be evaluated as a whole rather than treating each factor as a separate subscale. Accordingly, analyses are based on a single total score derived from the entire scale. The Cronbach's alpha coefficient of the original scale was reported as 0.80. In the present study, the Cronbach's alph"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Labor Pain', 'Active Phase of Labor', 'Stress Ball', 'Childbirth Comfort', 'Maternal Self-Efficacy'], 'conditions': ['Labor Pain', 'Pain Management', 'Maternal Self-Efficacy']}, 'descriptionModule': {'briefSummary': "This randomized controlled trial evaluates the effects of a stress ball intervention during the active phase of labor on maternal pain, childbirth comfort, self-efficacy, and labor progress. Labor pain is a multidimensional experience influenced not only by physiological factors but also by psychological processes such as coping and perceived control. Simple non-pharmacological methods may support women's ability to manage contractions during labor.\n\nParticipants in the intervention group use a stress ball during uterine contractions throughout the active phase of labor, while the control group receives routine midwifery care. Pain intensity is measured at predefined cervical dilatation levels using a visual analog scale. Childbirth comfort and general self-efficacy are assessed before and after birth. Labor progress parameters, including contraction characteristics and fetal heart rate, are also monitored.\n\nThe study aims to determine whether stress ball use improves women's experience of labor without negatively affecting physiological labor progress.", 'detailedDescription': 'This study is a single-center, parallel-group randomized controlled trial designed to evaluate the effects of a stress ball intervention during the active phase of labor. The intervention is based on the theoretical framework of distraction and self-efficacy, aiming to support coping and perceived control during uterine contractions without interfering with the physiological course of labor.\n\nEligible participants are low-risk pregnant women in the active phase of spontaneous labor (cervical dilatation ≥5 cm). After baseline assessment, participants are randomized in a 1:1 ratio to either the intervention group or the control group. The intervention group receives routine midwifery care plus stress ball use during contractions throughout the active phase, while the control group receives routine care only.\n\nPain intensity is assessed at predefined cervical dilatation levels using a visual analog scale. Childbirth comfort and general self-efficacy are measured before and after birth. Labor progress parameters are monitored as part of routine clinical practice to evaluate safety and ensure that the intervention does not negatively affect physiological labor processes.\n\nData are analyzed using appropriate statistical methods for repeated measures to examine group differences over time and the interaction between group and cervical dilatation. The study aims to determine whether stress ball use influences maternal outcomes and labor progression in a safe and supportive manner.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies between 37 and 42 weeks of gestation who were in the active phase of labor,\n* Had no mental or physical disabilities,\n* Could speak Turkish,\n* Volunteered to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant women with high-risk pregnancies,\n* Systemic diseases, a history of medical or obstetric complications,\n* Those using epidural analgesia or pharmacological pain management'}, 'identificationModule': {'nctId': 'NCT07451834', 'acronym': 'ACTIVE-BALL', 'briefTitle': 'Stress Ball Intervention During Active Labor', 'organization': {'class': 'OTHER', 'fullName': 'KTO Karatay University'}, 'officialTitle': 'Effect of Stress Ball Intervention During the Active Phase of Labor on Pain, Comfort, and Childbirth Self-Efficacy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KaratayU-RCT-StressBall-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress Ball + Routine Midwifery Care', 'description': 'Participants receive routine midwifery care plus stress ball use throughout the active phase of labor. Women are instructed to rhythmically squeeze the stress ball during uterine contractions and release it during relaxation phases. The intervention is integrated into contractions during active labor.', 'interventionNames': ['Device: Stress Ball']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Midwifery Care (Control)', 'description': 'Participants receive routine midwifery care only, including standard labor monitoring and supportive care according to hospital protocol.'}], 'interventions': [{'name': 'Stress Ball', 'type': 'DEVICE', 'description': 'A handheld stress ball used during uterine contractions throughout the active phase of labor to support coping through distraction and enhance perceived control.', 'armGroupLabels': ['Stress Ball + Routine Midwifery Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karatay', 'state': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'KTO Karatay University', 'geoPoint': {'lat': 37.86726, 'lon': 32.52863}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KTO Karatay University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.', 'investigatorFullName': 'Hediye Karakoç', 'investigatorAffiliation': 'KTO Karatay University'}}}}