LaborNCT05335681
The Effects of Warm Showers Application in Birth on Birth Pain, Birth Satisfaction and Birth Results
A study testing Warm Showers Application in people with Labor and Pregnancy, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Pregnancy, First Stage of Labor
- What is being tested?
- Warm Showers Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Labor, Pregnancy, First Stage of Labor
- Being tested
- Warm Showers Application
- Keywords
- warm shower, labor pain, birth Satisfaction, hydrotherapy, maternal health
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Showers ApplicationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Warm Showers Application | Experimental | 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. Receives: Behavioral: Warm Showers Application |
| Standard Intrapartum Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Labor Pain
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.
Measured: Baseline (Before the cervical dilation)
Labor pain
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.
Measured: 10 minutes after the cervical dilation
Labor pain
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.
Measured: 20 minutes after the cervical dilation
Secondary outcomes (1)
Birth satisfaction
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Jan 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Öznur Hayat Öktem, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335681
- Sponsor's protocol ID
- Hayat01
- Other IDs
- PhD midwifery
- Status last verified
- Jan 2026
- First submitted
- 2 Apr 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midwife Öznur Hayat Öktem
- ClinicalTrials.gov ID
- NCT05335681
- Acronym / sponsor ID
- Hayat01
- Conditions
- Labor, Pregnancy, First Stage of Labor
- Keywords
- warm shower, labor pain, birth Satisfaction, hydrotherapy, maternal health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Warm Showers Application | Experimental | Behavioral: Warm Showers ApplicationIn 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. |
| Standard Intrapartum Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm Showers ApplicationIn 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 | Behavioural | Warm Showers Application |
Primary outcome
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.
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Related trials for Labor
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Showers Application in people with Labor and Pregnancy, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor Pain (time frame: Baseline (Before the cervical dilation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.