Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05380258
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2022-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], '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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002638', 'term': 'Chewing Gum'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-14', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'labor pain', 'timeFrame': 'Visual Analog scale I for labor pain was applied in 0-3 cm , Visual Analog Scale II in 4-5 cm and Visual Analog Scale III was applied in 6-8 cm cervical dilatation. The study continues through study completion, an average of 1 year'}, {'measure': 'Duration of labor', 'timeFrame': 'A birth follow-up form was used from the beginning of cervical dilatation to delivery.'}, {'measure': 'birth satisfaction', 'timeFrame': 'satisfaction form used postpartum at the 4th hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chewing gum,', 'stress ball', 'labor pain', 'satisfaction'], 'conditions': ['Labor Pain', 'Birth Satisfaction', 'Duration of Birth']}, 'descriptionModule': {'briefSummary': "This study was conducted as a randomized controlled experimental study. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The population of the study consisted of primiparous mothers who applied to the hospital. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The study was carried out in two stages. In the first stage, the data were collected in the delivery room, and in the second stage, the postpartum satisfaction levels of the mothers were measured in the postpartum service. The sample number of the investigators' study was determined as 96. Visual analog scale, birth satisfaction scale and birth follow-up form were used for the data of our study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being primiparous to be in due time\n* To have spontaneous vaginal delivery\n* Ability to communicate verbally be between the ages of 18-35\n* Not having a risky pregnancy\n* Having a single fetus in the vertex position\n* Having started contractions and continuing regularly\n* Being in the latent phase of action (0-4 cm dilatation)\n* Not having used any analgesia or using any pain medication to reduce pain during labor\n\nExclusion Criteria:\n\n* Mothers who have a cesarean section decision\n* Risky Pregnant\n* Multiple Pregnancies\n* Multiparous pregnant women'}, 'identificationModule': {'nctId': 'NCT05380258', 'briefTitle': 'The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Kastamonu University'}, 'officialTitle': 'The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery', 'orgStudyIdInfo': {'id': 'KAEK-143-132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chewing gum', 'description': 'Pregnant women with 4-5 cm cervical dilatation started chewing gum as soon as their contractions came and they chewed gum for 20 minutes. and when the cervical dilation was 6-8 cm, they chewed gum again for 20 minutes.', 'interventionNames': ['Other: chewing gum']}, {'type': 'EXPERIMENTAL', 'label': 'stress ball', 'description': 'Pregnant women with 4-5 cm cervical dilatation were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes when their contractions came, and when the cervical opening was 6-8 cm, they were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes.', 'interventionNames': ['Other: stress ball']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'standard care'}], 'interventions': [{'name': 'stress ball', 'type': 'OTHER', 'description': 'Pregnant women with 4-5 cm cervical dilatation were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes when their contractions came, and when the cervical opening was 6-8 cm, they were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes.', 'armGroupLabels': ['stress ball']}, {'name': 'chewing gum', 'type': 'OTHER', 'description': 'Pregnant women with 4-5 cm cervical dilatation were asked to squeeze the ball for 5 seconds and loosen it for 2 seconds as soon as their contractions came and within 20 minutes, and when the cervical opening was 6-8 cm, they chewed gum again for 20 minutes.', 'armGroupLabels': ['chewing gum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37150', 'city': 'Merkez', 'state': 'Kastamonu', 'country': 'Turkey (Türkiye)', 'facility': 'Şahika Şimşek Çetinkaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kastamonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Şahika ŞİMŞEK ÇETİNKAYA', 'investigatorFullName': 'Şahika ŞİMŞEK ÇETİNKAYA', 'investigatorAffiliation': 'Kastamonu University'}}}}