NCT07031635

Brief Summary

Warm showers are increasingly gaining attention for their positive impact on labor, yet studies on this topic in Turkey remain limited. No previous research has simultaneously evaluated the effects of warm showers on labor pain, duration, emotional state, and breastfeeding. As a simple, economical, accessible, and side-effect-free method, warm showers represent a practical and safe non-pharmacological option for pain relief and comfort during labor. This study aimed to evaluate the effects of hydrotherapy on labor pain, duration, breastfeeding, and emotional experience during childbirth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 3, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

Breast FeedingLaborHydrotherapyLabor Pain

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Scale (VAS)

    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.

    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

  • Breastfeeding Scoring System (LATCH)

    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.

    Within the first two hours after birth

  • Birth Emotion Scale (BES)

    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.

    Within the first two hours after birth

  • Labor Monitoring Form

    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.

    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

Study Arms (2)

HYDROTHERAPY Group

EXPERIMENTAL

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.

Other: Hydrotherapy (Warm Shower)

Control group

NO INTERVENTION

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.

Interventions

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.

HYDROTHERAPY Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Eğitim ve Araştırma Hastanesi

Mardin, Midyat, 47100, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 31146759BACKGROUND
  • 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.

    PMID: 6226917BACKGROUND
  • 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.

    PMID: 29239794BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29512230BACKGROUND
  • 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.

    PMID: 30575638BACKGROUND

MeSH Terms

Conditions

Breast FeedingLabor Pain

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Hacer Alan Dikmen, Assoc. Prof.

    Selcuk Uni̇versi̇ty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
To prevent bias in the study sample, inclusion, exclusion, and withdrawal criteria were established. The intervention was performed solely by the researcher, therefore performance bias could not be prevented. Group assignments were done using random numbers generated by random.org, placed in opaque sealed envelopes, and assigned by an independent person not involved in the study. This ensured that participants were blinded to their group allocation. All data were collected by the researcher, who was aware of the group assignments; thus, measurement bias could not be prevented. However, data analyses were conducted by an independent statistician not involved in the research process, preventing statistical bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized control study: The pilot study was conducted between July 16 and August 15, 2024, with 10 primiparous pregnant women. Hydrotherapy was applied and the usability of data collection forms was assessed. Participants were satisfied with the application, and no revisions to the forms were needed. Intervention Group: When cervical dilation reached 5 cm, participants received a 30-minute warm shower, either standing or sitting based on their preference. Various assessment tools were used throughout labor, including the Visual Analog Scale, Labor Monitoring Form, LATCH Breastfeeding Scale, and Labor Affect Scale. Control Group: Aside from routine hospital procedures, no additional interventions were performed. The same assessment tools were applied during labor and postpartum.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 22, 2025

Study Start

July 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations