NCT05529823

Brief Summary

The research covers the birth memory evaluation to determine the pregnancy process, the labor process and the changes in the perceived pain level during this process, the parenting behavior immediately after the birth and the process of the birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 31, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

August 31, 2022

Last Update Submit

July 5, 2023

Conditions

Keywords

Labor PainBirth MemoriesParenting BehaviorHydrotherapy

Outcome Measures

Primary Outcomes (2)

  • Perceived pain level

    When cervical dilation is 4-5 cm and 7-8 cm, perceived labor pain will be defined by the visual pain scale.

    6 hours

  • Birth Memories and Recall Questionnaire

    It will be determined how taking a shower during labor will affect the birth memory.

    6 hours

Secondary Outcomes (1)

  • Postpartum Parenting Behavior Scale

    1 hours

Study Arms (2)

Experimental group

EXPERIMENTAL

The women in this group will have a warm shower during the labor process.

Behavioral: warm shower

Control group

NO INTERVENTION

Women in the control group will not be interfered with and will be followed in line with the routine follow-up protocol of the clinic.

Interventions

warm showerBEHAVIORAL

A warm shower will be applied for 20 minutes to the pregnant woman whose cervical dilatation reaches 4-5 cm and 7-8 cm.

Experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being able to communicate verbally
  • Between 18 - 45 years old,
  • Being Primiparous/Nulliparous,
  • Term pregnancy (38-41 weeks of pregnancy),
  • Being in the latent and active phase of labor (Cervical dilation 4-5 cm and 7-8 cm)
  • Having a single fetus
  • Fetus in vertex presentation,
  • Low risk pregnancy and no complications (EMR, Placenta Previa, HT, DM etc.),
  • No obstetric risk (diabetes, pre-eclampsia, premature birth threat, etc.)
  • Not having had any surgery in the spinal region,
  • Volunteer to participate in the research

You may not qualify if:

  • Not being willing to participate in the study,
  • Not being open to communication and cooperation,
  • Presence of hearing-sight and mental problems that would prevent the research,
  • Be younger than 18 years old, over 45 years old,
  • Being multiparous
  • Being outside 38-41 weeks of gestation
  • Being in the transitional phase of birth,
  • Not planning a vaginal birth,
  • Decision of cesarean delivery during labor,
  • Presence of any medical or obstetric risk factors (fetal distress, prolonged labor, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Training and Research Hospital

Sakarya, Kocaeli, Turkey (Türkiye)

Location

Related Publications (6)

  • Britton HL, Gronwaldt V, Britton JR. Maternal postpartum behaviors and mother-infant relationship during the first year of life. J Pediatr. 2001 Jun;138(6):905-9. doi: 10.1067/mpd.2001.113358.

  • Callister LC. Making meaning: women's birth narratives. J Obstet Gynecol Neonatal Nurs. 2004 Jul-Aug;33(4):508-18. doi: 10.1177/0884217504266898.

  • Shaw-Battista J. Systematic Review of Hydrotherapy Research: Does a Warm Bath in Labor Promote Normal Physiologic Childbirth? J Perinat Neonatal Nurs. 2017 Oct/Dec;31(4):303-316. doi: 10.1097/JPN.0000000000000260.

  • Cluett ER, Burns E, Cuthbert A. Immersion in water during labour and birth. Cochrane Database Syst Rev. 2018 May 16;5(5):CD000111. doi: 10.1002/14651858.CD000111.pub4.

  • WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/

  • Kulac V, Baskaya YH. The Effect of Showering During Labour on Perceived Labour Pain, Parenting Behaviour and Birth Memory: A Randomised Controlled Clinical Trial. Int J Nurs Pract. 2025 Oct;31(5):e70055. doi: 10.1111/ijn.70055.

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Since there is no placebo group, masking only outcomes assessor.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: While warm showers will be used during labor in the experimental group, routine midwifery care will be applied in the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Midwifery Depatment

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 7, 2022

Study Start

October 1, 2022

Primary Completion

March 31, 2023

Study Completion

July 4, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The follow-up of the study data will be provided by both researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be kept by the researchers until the study is reported. After the study is published, it will contribute to the literature.

Locations