NCT07808840

Brief Summary

The goal of this clinical trial is to learn whether the wet towel method applied during the first stage of labor can reduce labor pain and anxiety and improve childbirth comfort in first-time mothers. The main questions it aims to answer are: Does the wet towel method reduce labor pain? Does the wet towel method improve childbirth comfort? Does the wet towel method reduce anxiety during labor? Researchers will compare women who receive the wet towel method in addition to routine intrapartum care with women who receive routine intrapartum care alone to determine whether the intervention improves maternal outcomes during labor. Participants will: Be randomly assigned to either the wet towel intervention group or the routine care control group. Receive the wet towel application for at least 10 minutes during the active phase of the first stage of labor or receive routine intrapartum care only. Complete assessments of labor pain, childbirth comfort, and anxiety before and after the intervention using validated measurement tools

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress31%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

August 25, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 25, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

August 25, 2026

Last Update Submit

September 8, 2026

Conditions

Keywords

LaborWet Towel MethodVaginal BirthRandomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

  • Pain intensity assessed by Visual Analog Scale (VAS)

    The primary outcome of this study is to evaluate the effect of wet towel application on labor pain intensity. Pain intensity will be assessed using the Visual Analog Scale (VAS) before and after the intervention.The primary outcome is labor pain intensity, assessed using the Visual Analog Scale before and after the intervention. Scores range from 0 to 10, with higher scores indicating greater labor pain intensity.

    Before intervention and immediately after intervention during the active phase of labor.

  • Childbirth comfort level assessed by Childbirth Comfort Questionnaire

    The effect of wet towel application on childbirth comfort levels will be evaluated using the Childbirth Comfort Questionnaire before and after the intervention. Total scores range from 9 to 45, with higher scores indicating a higher level of childbirth comfort.

    Before intervention and immediately after intervention.

  • Anxiety level during labor assessed by Anxiety Assessment Scale for Pregnant Women in Labor

    The effect of wet towel application on anxiety levels during labor will be evaluated. Anxiety level during labor will be assessed using the Scale for Assessing the Anxiety Status of Pregnant Women in Labor before and after the intervention. The mean score ranges from 1 to 5, with higher scores indicating higher levels of anxiety during labor.

    Before intervention and immediately after intervention.

Study Arms (2)

wet Towel group

EXPERIMENTAL
Other: Wet Towel

control

NO INTERVENTION

Interventions

A woman who has entered the active phase and is being treated will be safely escorted to the bathroom and prepared for the procedure. A clean towel will be placed over the woman's head and shoulders, and water at an appropriate temperature (approximately 36-38°C) will be directed in a slow stream from the showerhead onto the towel. The water flow will be adjusted so that it gently touches the head area through the towel, and the procedure will be continued for at least 10 minutes. During this process, the woman will be continuously monitored, her comfort and safety will be ensured, and the fetal heart rate will be monitored in accordance with institutional protocol. After the procedure is completed, the woman's head and shoulders will be dried, and she will be taken back to her room for further assessment. Translated with DeepL.com (free version)

wet Towel group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study includes pregnant women only.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women admitted to the delivery room for childbirth
  • Pregnant women without any risks
  • Pregnant women with sufficient language proficiency to communicate effectively
  • Women experiencing their first pregnancy

You may not qualify if:

  • Pregnant women admitted for a planned cesarean section
  • Pregnant women who do not agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Training and Research Hospital

Adapazarı, Sakarya, 54050, Turkey (Türkiye)

Location

Related Publications (3)

  • Shishido I, Konya I, Yano R. Effect on autonomic nervous activity of applying hot towels for 10 s to the back during bed baths. J Physiol Anthropol. 2020 Nov 19;39(1):35. doi: 10.1186/s40101-020-00245-7.

  • Mellado-Garcia E, Diaz-Rodriguez L, Cortes-Martin J, Sanchez-Garcia JC, Piqueras-Sola B, Macias JCH, Rivas Ruiz F, Rodriguez-Blanque R. Comparative Analysis of Therapeutic Showers and Bathtubs for Pain Management and Labor Outcomes-A Retrospective Cohort Study. J Clin Med. 2024 Jun 15;13(12):3517. doi: 10.3390/jcm13123517.

  • Taskin A, Ergin A. Effect of hot shower application on pain anxiety and comfort in the first stage of labor: A randomized controlled study. Health Care Women Int. 2022 May;43(5):431-447. doi: 10.1080/07399332.2021.1925282. Epub 2021 Jun 22.

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • YASEMİN BAŞKAYA

    Sakarya University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

August 25, 2026

First Posted

September 9, 2026

Study Start

August 25, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the data contain sensitive health information from pregnant women. To protect participant confidentiality and privacy, only aggregated results will be reported.

Locations