- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07031635
- Original Trial
Hydrotherapy in Labor: Outcomes for Pain, Birth, and Breastfeeding (HYDROTHERAPY)
The Effect of Hydrotherapy During Labor on Labor Pain, Duration of Labor, Birth Affectivity, and Breastfeeding
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Childbirth is an unforgettable and unique experience for women. However, labor can sometimes be painful, challenging, and anxiety-inducing. Severe labor pain can negatively affect a woman's sense of control during labor, causing stress that may impact the health of the mother, fetus, and newborn. Traumatic birth experiences may hinder maternal-infant bonding and breastfeeding. Factors such as delivery method, medical interventions, pain, and fatigue can delay the initiation of breastfeeding and complicate the mother's adjustment to her new role. In supportive, intervention-free birth environments, the need for analgesia and oxytocin is reduced, episiotomy rates are lower, maternal emotional experiences improve, and breastfeeding is initiated earlier.
In this context, non-pharmacological methods such as warm showers offer significant advantages during labor. Being easily accessible, economical, and free of side effects, warm showers help relax muscles, improve circulation, reduce labor pain, and support a more positive maternal approach to the birth process. They ease fear and stress, promote comfort, and increase birth satisfaction. Studies indicate that pregnant women find warm showers soothing and often prefer them over analgesics. However, studies in Turkey on this subject are limited, and comprehensive research evaluating the combined effects of warm showers on labor pain, duration, emotional state, and breastfeeding is lacking. Therefore, this study was conducted to assess the effects of hydrotherapy during labor on these outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Midyat
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Mardin, Midyat, Turkey, 47100
- Mardin Eğitim ve Araştırma Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primiparous women who were expected to give birth vaginally
- Women who became pregnant spontaneously
- Women who were in the latent phase of labor upon admission
- Women who were not given oxytocin
- Women who were at term (38-42 weeks of gestation)
- Women who had a single healthy fetus in the vertex position
- Women who did not have any risk factors (such as preeclampsia, eclampsia, placenta previa, or placental abruption).
Exclusion Criteria:
- Pregnant women with any complications that could cause dystocia during labor (such as contraction abnormalities birth objects, birth canal dystocia, maternal psychological dystocia)
- Who are unable to move
- Who cannot speak, read, or understand Turkish
- Who have communication problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HYDROTHERAPY Group
Pregnant women who met the inclusion criteria and agreed to participate in the intervention group received a warm shower once cervical dilation reached 5 cm.
Based on their preference, participants either stood or sat during the 30-minute shower.
After random assignment, the participants in the intervention group completed the "Informed Consent Form," "Personal Information Form," and the "Visual Analog Scale (VAS)" upon admission to the delivery room.
During the 1st, 2nd, 3rd, and 4th stages of labor, the "Labor Monitoring Form" was used, and the VAS was repeated immediately after the intervention, and again at 30 and 60 minutes.
Breastfeeding status was assessed using the LATCH scale within the first two hours after birth, and emotional responses to birth were evaluated using the Labor Affect Scale.
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Pregnant women who met the inclusion criteria and agreed to participate in the intervention group received a warm shower once cervical dilation reached 5 cm.
Based on their preference, participants either stood or sat during the 30-minute shower.
|
|
No Intervention: Control group
In the control group, routine hospital procedures were followed, including admission, history-taking, informed consent, recording of vital signs, and connecting the mother to the non-stress test (NST) monitor.
No additional intervention was administered.
After random assignment, control group participants also completed the "Informed Consent Form," "Personal Information Form," and "Visual Analog Scale" at admission.
The "Labor and Postpartum Monitoring Form" was used during the 1st through 4th stages of labor, and the VAS was repeated at 30 and 60 minutes after entering the active phase.
Within the first two hours postpartum, breastfeeding was evaluated using the LATCH scale, and emotional responses to birth were assessed using the Labor Affect Scale.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: First time: Latent phase of labor, Second time: Second stage of labor (the stage in which the baby is born), Third time: Third stage of labor (the stage in which the placenta is born), Forth time: Second hour after birth
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The VAS is used to assess the pain felt.
On the VAS, the patient marks the location of their pain on a ruler.
This ruler is 10 cm long.
One end of the ruler indicates no pain, and the other end indicates the most unbearable pain.
The use of this scale must be explained very clearly to the pregnant woman.
The pregnant woman is told that there are two endpoints on the ruler and that she should mark the point between these two endpoints that best represents the intensity of her pain.
The distance between the "no pain" point and the point marked by the pregnant woman is measured in centimeters using the ruler and recorded.
This determines the pregnant woman's pain level.
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First time: Latent phase of labor, Second time: Second stage of labor (the stage in which the baby is born), Third time: Third stage of labor (the stage in which the placenta is born), Forth time: Second hour after birth
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Breastfeeding Scoring System (LATCH)
Time Frame: Within the first two hours after birth
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The LATCH scale is a tool used to assess mothers' breastfeeding behaviors and skills.
Developed by Jensen et al. in 1994, it evaluates five key areas: L (Latch onto the breast), A (Audible swallowing), T (Type of nipple), C (Comfort of breast/nipple), and H (Hold/positioning).
Each criterion is scored 0 to 2 points, with a total score ranging from 0 to 10. Higher scores reflect more effective breastfeeding, while lower scores indicate potential difficulties.
The scale's reliability and validity for the Turkish population were confirmed by Koyun (2001) and Okumuş and Yenal (2003).
Widely used by healthcare professionals, the LATCH scale helps identify breastfeeding challenges early and supports mothers through education and intervention, promoting better breastfeeding outcomes and bonding.
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Within the first two hours after birth
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Birth Emotion Scale (BES)
Time Frame: Within the first two hours after birth
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The Birth Emotion Scale (BES), developed by Hodnett in 1987, measures women's emotional experiences during childbirth.
Gençalp validated and tested its reliability for the Turkish population in 1998.
The scale contains 28 items scored on a 5-point Likert scale with options: "constantly," "frequently," "occasionally," "very rarely," and "never," coded from 1 to 5. Higher scores indicate more positive emotions during birth, while lower scores reflect negative emotions.
Total scores range from 40 to 140.
The Turkish version showed high internal consistency with a Cronbach's alpha of 0.87.
The BES is widely used in research and clinical settings to assess psychological responses to childbirth and guide supportive care.
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Within the first two hours after birth
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Labor Monitoring Form
Time Frame: First time: Latent phase of labor, Second time: Second stage of labor (the stage in which the baby is born), Third time: Third stage of labor (the stage in which the placenta is born), Forth time: Second hour after birth
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To determine labor stage durations in pregnant women, researchers recorded key time points during labor and delivery.
These included hospital arrival, and transitions between labor stages: latent, active, transition phases, birth, placenta delivery, and transfer to the postpartum ward.
Timing was measured in minutes for accuracy.
The latent phase involves mild contractions and cervical dilation up to 4 cm.
The active phase features stronger contractions and dilation from 4 to 7 cm.
The transition phase completes dilation to 10 cm.
Measuring these stages, along with placenta delivery and postpartum transfer, provides valuable data to assess labor progress, detect abnormalities, and evaluate interventions.
This detailed timing supports improved obstetric care tailored to each woman's needs.
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First time: Latent phase of labor, Second time: Second stage of labor (the stage in which the baby is born), Third time: Third stage of labor (the stage in which the placenta is born), Forth time: Second hour after birth
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Hacer Alan Dikmen, Assoc. Prof., Selcuk University
Publications and helpful links
General Publications
- Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
- ACOG Committee Opinion No. 766: Approaches to Limit Intervention During Labor and Birth. Obstet Gynecol. 2019 Feb;133(2):e164-e173. doi: 10.1097/AOG.0000000000003074.
- Henrique AJ, Gabrielloni MC, Rodney P, Barbieri M. Non-pharmacological interventions during childbirth for pain relief, anxiety, and neuroendocrine stress parameters: A randomized controlled trial. Int J Nurs Pract. 2018 Jun;24(3):e12642. doi: 10.1111/ijn.12642. Epub 2018 Mar 7.
- Thomson G, Feeley C, Moran VH, Downe S, Oladapo OT. Women's experiences of pharmacological and non-pharmacological pain relief methods for labour and childbirth: a qualitative systematic review. Reprod Health. 2019 May 30;16(1):71. doi: 10.1186/s12978-019-0735-4.
- Mallen-Perez L, Roe-Justiniano MT, Colome Ochoa N, Ferre Colomat A, Palacio M, Terre-Rull C. Use of hydrotherapy during labour: Assessment of pain, use of analgesia and neonatal safety. Enferm Clin (Engl Ed). 2018 Sep-Oct;28(5):309-315. doi: 10.1016/j.enfcli.2017.10.004. Epub 2017 Nov 24. English, Spanish.
- M. (2018). "Comparing the effects of hot shower and intravenous injection of hyoscine on the pain intensity and duration of active phase of labour in nulliparous women". Journal of Clinical and Diagnostic Research, 12(8), QC07-QC11.
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/1177
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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