Effect of Nonpharmacological Methods on The Active Phase Of Labour

Not Applicable

Completed

• Conditions: Labour Pains; Massage; Exercise

• Registration Number: NCT07060339
• Lead Sponsor: Uskudar University

Brief Summary

The aim of this clinical trial is to evaluate the effects of methods such as exercise and hot showers applied during the active phase of labour on labour pain, labour duration, mode of delivery, newborn health, and the labour experience. In addition, the safety of these methods in terms of maternal and infant health will also be observed.

The main questions it aims to answer are:

Do exercise and warm shower applications reduce labour pain?

Do these methods shorten the duration of labour?

Is there a relationship between exercise and warm shower applications and the mode of delivery (vaginal birth/caesarean section)?

Do these practices affect the newborn's APGAR score?

Do women who use these methods have a more positive birth experience?

Participants:

Women who have started labour, are between 38 and 42 weeks pregnant, are expecting a single baby, and are having their first birth.

Participants will be randomly assigned to one of four groups:

Exercise

Warm shower

Exercise + warm shower

Pharmacological intervention (control group)

What is expected of participants:

Participate in exercise, warm shower, breathing exercises, and massage applications (depending on the group they are in) throughout the labour process

Participate in monitoring and evaluations during clinical check-ups

Complete postpartum questionnaires and scales related to the birth experience

This clinical study is being conducted to scientifically evaluate the effectiveness of non-pharmacological methods used during childbirth and to improve the birth experience.

Detailed Description

In the study, data were collected face-to-face with a single midwife. The data used in the study were the Informed Consent Form; the Informative Information Form developed by the researchers in line with the literature Information Form , the Birth Monitoring Form used during childbirth, the Visual Analogue Scale - VAS, the Postpartum Assessment Form, and the Birth Experience Scale.

Study Timeline

• Study Start: 2023-01-27
• Primary Completion: 2024-02-12
• Study Completion: 2025-05-28
• Study First Submitted: 2025-05-28
• Status Verified: 2025-06
• Study First Submitted QC: 2025-07-01
• Study First Posted: 2025-07-11
• Last Update Submitted: 2025-07-23
• Last Update Posted: 2025-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Comparison Scale (Vizual Analogue Scale -VAS)	VAS is used repeatedly during the 4-5 cm, 6-7 cm, 8-9 cm and full dilation stages of labour, before and after massage, exercise and hot shower applications, and during intervention when necessary.	VAS was used before and after each intervention to assess the level of pain during the birth process. Repeated measurements were taken between applications to monitor changes in pain and measure the effectiveness of the interventions.
Birth Experience Scale (BES)	By assessing her overall satisfaction with the birth process, it measures how she felt about the birth process and her physical and emotional experiences. It was completed within 24 hours after birth.	It consists of 22 items and has 4 sub-dimensions.

Trial Locations

Locations (1)

Üsküdar Üniversitesi Sağlık Bilimleri Fakültesi, İstanbul, Ümraniye 34662; 🇹🇷 İstanbul, Ümraniye, Turkey