Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT07165405
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Hot Sacral Massage and Shower Application With Partner Support on Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008405', 'term': 'Massage'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scale', 'timeFrame': 'Before the shower and massage at 4-5 cm dilation, After the shower and massage at 4-5 cm dilation, Before the shower and massage at 6-8 cm dilation, After the shower and massage at 6-8 cm dilation. Control group: at 4-5 cm dilation and 6-8 cm dilation', 'description': 'labour pain'}], 'secondaryOutcomes': [{'measure': 'Childbirth Experience Questionnaire', 'timeFrame': 'Before the transfer from the delivery room to the maternity ward after birth', 'description': "The scale to be used to measure women's birth experiences in different dimensions has four sub-dimensions and 22 items. In the birth process sub-dimension, women's sense of personal control and their feelings about the birth process and birth pain are evaluated. In the professional help/support sub-dimension, information and midwifery care are evaluated. The perceived safety/memories sub-dimension examines feelings of safety and memories/records of the birth. The participation in decisions sub-dimension examines participation in decisions regarding movement, birth position, and pain relief. A higher score on the scale indicates that the expectant mother had a positive birth experience."}, {'measure': 'Childbirth Comfort Questionnaire', 'timeFrame': 'Before the transfer from the delivery room to the maternity ward after birth', 'description': "The scale has a 3-factor structure (physical, environmental, psychospiritual). It is used to assess the woman's comfort level during childbirth. A higher score indicates a higher level of comfort, while a lower score indicates a lower level of comfort."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['labor pain', 'birth experience', 'postpartum comfort', 'sacral massage', 'shower application'], 'conditions': ['Pain', 'Experience', 'Comfort']}, 'descriptionModule': {'briefSummary': 'This study was designed to determine the effect of warm sacral massage with cherry pits and showering with partner support on perceived labor pain, birth experience, and birth comfort. A total of 150 pregnant women, 50 in each group, were planned to be included in the study.\n\nVolunteers who agreed to participate in the study were expected to have spontaneous vaginal delivery, with an ultrasound-estimated fetal weight between 2500-4000 grams, a single fetus in cephalic presentation, at term (between 37-42 weeks of gestation), in the active phase of labor (4 cm cervical dilation), primiparous women who did not receive analgesia or anesthesia during the first stage of labor and who did not have any skin disease or open wound that would prevent massage or showering. Pregnant women participating in the study will be randomly divided into three groups. The massage group will receive massage twice during the first stage of labor for at least 20 minutes, either standing or sitting, using a bag filled with cherry pits on the sacral region (the lumbar region including your tailbone). Pregnant women in the shower group will receive a shower with water at a temperature between 32-37°C for at least 20 minutes twice during the first stage of labor, either standing or sitting with partner support, according to their preference. Pregnant women in the control group will not receive any intervention other than the routine hospital protocol (midwifery care).\n\nAfter providing information about the study to the pregnant women, written informed consent will be obtained. The pain scale (VAS) will be administered to women in the shower group, massage group, and control group by a midwife working in the delivery room who is not involved in the study. The VAS will be administered four times during labor to pregnant women in the massage group and shower group, and four times to pregnant women in the control group.\n\nBefore transfer to the ward after delivery, all participants in the groups will be administered the "Birth Experience Scale (BES) and Birth Comfort Scale (BCS)" by a midwife who is not involved in the study and is working in the delivery room that day.', 'detailedDescription': 'This study aims to determine the effect of warm sacral massage with cherry pits and shower application with partner support on perceived labor pain, birth experience, and birth comfort. The study includes three groups: massage group, shower group, and control group. A total of 150 pregnant women, 50 in each group, were included in the study.\n\nSteps for the Partner-Assisted Shower Application: Participants in this group will receive a shower administered by their partner in the delivery room (when dilation is 4-5 cm) for at least 20 minutes. The water temperature will be between 32-37 °C (the woman\'s preferred temperature will be used), and the shower will be administered to the lower back, abdomen, or entire body, depending on the woman\'s preference, while she is standing or sitting, under the observation of the researcher midwife. The application will be repeated when dilation reaches 7-8 cm. To ensure the safety of pregnant women before showering, non-slip sandals or slippers will be provided, and a non-slip bath mat will be placed under the stool. Blood pressure will be checked before and after showering.\n\nCherry Pit Hot Sacral Massage Group: The sacral massage will be performed using 20x20 cm pouches filled with cherry pits. The pouches will be cover-shaped, and 100% cotton fabric will be preferred. Each pregnant woman will receive a massage with a washed, clean pouch. Like the shower application, the massage will be performed upon admission to the delivery room (when dilation is 4-5 cm) and repeated when dilation is 7-8 cm. It will begin when contractions start and will last approximately 20 minutes.\n\nControl group application steps: Participants in this group will not receive any application other than the routine hospital protocol (midwifery care).\n\nThe vital signs (blood pressure, pulse) of all pregnant women in the groups will be measured hourly by the midwife and recorded in each participant\'s file.\n\nThe VAS will be administered to women in the shower group, massage group, and control groups by a midwife working in the delivery room who is not involved in the study. The VAS will be measured four times during the first stage of labor for pregnant women in the shower and massage groups.\n\nAfter delivery, before transfer to the ward, the "Birth Experience Scale (BES) and Birth Comfort Scale (BCS)" will be administered to all participants in the groups by a midwife who is not involved in the study and who is working in the delivery room that day.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the study\n* Expectation of spontaneous vaginal delivery\n* Estimated fetal weight between 2500-4000 grams by ultrasound\n* Single fetus and cephalic presentation,\n* Term pregnancy (between 37-42 weeks of gestation)\n* Being in the active phase of labor (cervical dilation of 4 cm)\n* No analgesia or anesthesia used during the first stage of labor,\n* No skin disease or open wound preventing massage or showering\n\nExclusion Criteria:\n\n* Having undergone infertility treatment,\n* Delivery by cesarean section for any reason during labor,\n* Being multiparous\n* Having any systemic, chronic, or neurological disease (Diabetes Mellitus, Hypertension, Thyroid disorders, Multiple Sclerosis, Epilepsy, etc.)\n* Regular medication use due to any illness,\n* Active psychiatric treatment (pharmacotherapy/psychotherapy),\n* Any induction that may affect uterine contractions and dilation,\n* Any pregnancy complications (such as placenta previa, preeclampsia, premature rupture of membranes, oligohydramnios, and polyhydramnios)\n* Interventional delivery (forceps, vacuum)\n* Any problem that hinders communication (such as not knowing Turkish, hearing, speech, and comprehension disorders)'}, 'identificationModule': {'nctId': 'NCT07165405', 'briefTitle': 'Effects of Hot Sacral Massage and Shower Application With Partner Support on Labor', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The Effect of Hot Sacral Massage With Cherry Pits and Shower Application With Partner Support on Perceived Labor Pain, Birth Experience, and Birth Comfort', 'orgStudyIdInfo': {'id': '12/32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Showering with Partner Support', 'description': "Participants in this group will receive a shower administered by their partner on their back, abdomen, or entire body while standing or sitting, with the water temperature maintained between 32-37°C (the woman's preferred temperature will be applied) for at least 20 minutes upon admission to the labor room (when dilation is 4-5 cm). This will be performed under the observation of the researcher midwife. The application will be repeated when dilation reaches 7-8 cm.", 'interventionNames': ['Other: Shower']}, {'type': 'EXPERIMENTAL', 'label': 'Hot Sacral Massage Group Made with Cherry Pits', 'description': 'Sacral Massage Application will be performed using 20x20 cm pouches filled with cherry pits. Like the shower application, massage will be performed upon admission to the delivery room (when dilation is 4-5 cm) and repeated when dilation reaches 7-8 cm. Unless the pregnant woman requests otherwise, massage will be performed while she is in the left lateral position.', 'interventionNames': ['Other: Massage']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Participants in this group will not receive any treatment beyond the routine hospital protocol (midwifery care).', 'interventionNames': ['Other: Midwifery Care']}], 'interventions': [{'name': 'Shower', 'type': 'OTHER', 'description': "Participants in this group will receive a shower administered by their partner on their back, abdomen, or entire body while standing or sitting, with the water temperature maintained between 32-37°C (the woman's preferred temperature will be applied) for at least 20 minutes upon admission to the labor room (when dilation is 4-5 cm). This will be performed under the observation of the researcher midwife. The application will be repeated when dilation reaches 7-8 cm.", 'armGroupLabels': ['Showering with Partner Support']}, {'name': 'Massage', 'type': 'OTHER', 'description': 'Sacral Massage Application will be performed using 20x20 cm pouches filled with cherry pits. Like the shower application, massage will be performed upon admission to the delivery room (when dilation is 4-5 cm) and repeated when dilation reaches 7-8 cm. Unless the pregnant woman requests otherwise, massage will be performed while she is in the left lateral position.', 'armGroupLabels': ['Hot Sacral Massage Group Made with Cherry Pits']}, {'name': 'Midwifery Care', 'type': 'OTHER', 'description': 'Care provided by a midwife in the delivery room', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Büyükçekmece', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Neriman Güdücü, PhD.', 'role': 'CONTACT', 'email': 'nerimanteker@windowslive.com', 'phone': '+905548327328'}, {'name': 'Sevil Günaydın, PhD.', 'role': 'CONTACT', 'email': 'sevil.gunaydin@iuc.edu.tr', 'phone': '+905465995383'}], 'facility': 'Istanbul University-Cerrahpaşa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Neriman Güdücü, PhD.', 'role': 'CONTACT', 'email': 'nerimanteker@windowslive.com', 'phone': '+905548327328'}, {'name': 'Buket Hasmili, Master Student', 'role': 'CONTACT', 'email': 'bukethasmili@gmail.com', 'phone': '+905437269413'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Neriman Guducu', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}