- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05335681
The Effects of Warm Showers Application in Birth on Birth Pain, Birth Satisfaction and Birth Results
Midwife Öznur Hayat Öktem
The use of non-pharmacological methods in labor pain is very important in order to improve the birth process, increase comfort and provide relaxation. The role of midwives, acting as patient advocate is to maintain comfort throughout the birth process. In order to do this, she should know very well the non-pharmacological methods to be applied to the pregnant woman and choose the most appropriate one. Applying a warm shower, which is one of the non-pharmacological methods; the uterus Increases perfusion, makes labor painless felt, increases the release of oxytocin, and decreases the release of stress hormones.
In addition, while reducing the intervention rates, it improves birth and newborn outcomes and affects positively. Purpose of the research; labor pain of warm shower application, labor to evaluate the effect on satisfaction and birth outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Karabük, Turkey (Türkiye)
- Öznur Hayat Öktem
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 18 and 35,
- Having a singleton fetus between 37-42 weeks of gestation,
- Planning a a spontaneous vaginal birth,
- Having a cervical dilatation <5 cm.
- Having a fetus weighing between 2500-4000 grams,
Exclusion Criteria:
- Being short (<145cm),
- Being obese (BMI >30),
- Receiving pharmacological or non-pharmacological intervention for labor pain,
- Having chronic diseases during pregnancy (gestational diabetes, hypertension, preeclampsia,
- Undergoing operative vaginal delivery (forceps, vacuum),
- Making an emergency cesarean decision,
- Experiencing abnormal changes in fetal heart rates.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Warm Showers Application
In the experimental group, a 20-minute warm shower (37 °C) will be administered when cervical dilation reaches at least 4 cm and again at 7 cm.
The control group will receive standard care only.
The hot shower will be applied to the sacral area, lower abdomen, and groin regions.
|
In the experimental group, a 20-minute warm showers (37 °C) will be administered when cervical dilation reaches at least 4 cm and again at 7 cm. The control group will receive standard care only. The warm showers will be applied to the sacral area, lower abdomen, and groin regions. Throughout the intervention, the researcher will accompany the pregnant women to ensure safety and proper implementation of the procedure. Pain will be assessed using the VAS scale before the intervention and at 10 and 20 minutes after the intervention. The Birth Satisfaction Scale will be administered prior to discharge |
|
No Intervention: Standard Intrapartum Care
No intervention will be provided to the control group.
At the stages when cervical dilation reaches 4 cm and 7 cm, pain will be evaluated using the VAS at baseline, 10 and 20 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Labor Pain
Time Frame: Baseline (Before the cervical dilation)
|
Visual analog scale:On a 10 cm (100 mm.) ruler, which is marked painlessness on one end and the most severe pain possible on the other, the patient expresses his or her own pain by drawing a line, pointing or pointing.
The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain.
|
Baseline (Before the cervical dilation)
|
|
Labor pain
Time Frame: 10 minutes after the cervical dilation
|
Visual analog scale.On a 10 cm (100 mm.) ruler, which is marked painlessness on one end and the most severe pain possible on the other, the patient expresses his or her own pain by drawing a line, pointing or pointing.
The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain.
|
10 minutes after the cervical dilation
|
|
Labor pain
Time Frame: 20 minutes after the cervical dilation
|
Visual analog scale.On a 10 cm (100 mm.) ruler, which is marked painlessness on one end and the most severe pain possible on the other, the patient expresses his or her own pain by drawing a line, pointing or pointing.
The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain.
|
20 minutes after the cervical dilation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Birth satisfaction
Time Frame: Pregnant women in both groups will be visited by the researcher in the postpartum service within the first 24 hours postpartum and BSC will be applied.
|
The birth satisfaction scale (BSS).The scale is likert type and is scored as Strongly agree:5, Agree:4, Undecided:3, Disagree:2, Strongly disagree:1.
Items 4, 8, 12, 15, 16, 17, 19, 20, 21, 23, 25, 29 are scored in reverse on the scale.
The original form of the scale consists of 30 items, and the score that can be obtained from the scale varies between 30-150 points.
As the score obtained from the scale increases, the satisfaction with the birth increases.
|
Pregnant women in both groups will be visited by the researcher in the postpartum service within the first 24 hours postpartum and BSC will be applied.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hayat01
- PhD midwifery (Registry Identifier: GulhaneSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Kafrelsheikh UniversityNot yet recruitingEctopic PregnancyEgypt
-
Meir Medical CenterRecruiting
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Bagcilar Training and Research HospitalRecruitingEctopic PregnancyTurkey (Türkiye)
-
MELISA Institute Genomics & Proteomics Research...RecruitingHealthy | Pregnancy | Early Pregnancy | Early Pregnancy Loss | ChildbirthChile
-
Turku University HospitalUniversity of TurkuCompleted
-
Hopital Antoine BeclereUnknown
Clinical Trials on Warm Showers Application
-
Catholic University of the Sacred HeartRecruiting
-
Istanbul University - CerrahpasaIstanbul Training and Research Hospital; Uskudar UniversityCompleted
-
Selcuk UniversityCompletedPain | Cesarean Section Complications | Postpartum AnxietyTurkey
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompleted
-
University Hospital, Basel, SwitzerlandCompletedSick LeaveSwitzerland
-
Alexandria UniversityCompletedPostoperative Pain | Gynecologic NursingEgypt
-
Asmaa Abdallah Ahmed HusseinCairo UniversityCompleted
-
Dana-Farber Cancer InstituteCompletedPediatric Cancer | Skin Inflammation | CNS Tumor, ChildhoodUnited States
-
Opti'MouvUniversité Grenoble-AlpesCompleted
-
McGill UniversityNatural Sciences and Engineering Research Council, Canada; IDA sports; Soccer...Completed