Effect of Nonpharmacological Methods on The Active Phase Of Labour

NCT07060339 | Completed

• 1 other identifier: 2023-2/27
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Labour Pains; Massage; Exercise

Keywords

Labour Pain; Active Phase; Pain Management Techniques; Birth Experience; Midwifery Care

Outcome Measures

Primary Outcomes (2)

• Visual Comparison Scale (Vizual Analogue Scale -VAS)

  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.

  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.

• Birth Experience Scale (BES)

  It consists of 22 items and has 4 sub-dimensions.

  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.

Study Arms (4)

1. Intervention Group 1 - Exercise Programme

EXPERIMENTAL

Participants in this group were provided with midwifery care, breathing exercises, massage and exercise programmes during the active phase of labour. This group was formed to monitor the effects of exercise on the labour process.

Behavioral: Exercise Programme

2. Intervention Group 2 - Hot Shower Programme

EXPERIMENTAL

Participants in this group received midwifery care, breathing exercises, massage, and hot shower applications during the active phase of labour. This arm was designed to evaluate the effects of hot showers on labour pain, duration, and comfort.

Behavioral: Hot Shower Programme

3. Intervention Group 3 - Combined Application (Exercise + Hot Shower)

EXPERIMENTAL

In this group, midwifery care, breathing exercises, massage, exercise, and hot shower applications were applied together during the active phase of labour. This arm was designed to examine the effects of combining multiple non-pharmacological methods.

Behavioral: Combined Application (Exercise + Hot Shower)

4. Intervention Group - Pharmacological Intervention

EXPERIMENTAL

This group was monitored during the birth process with only midwifery care and routine pharmacological interventions. It serves as the standard care group that did not receive non-pharmacological interventions for comparison with other groups.

Behavioral: Pharmacological Intervention

Interventions

Exercise Programme BEHAVIORAL

Midwifery care, breathing exercises, massage and exercise applications were performed on pregnant women in this group during the active phase of labour. Following breathing exercises, massage was applied for 10 minutes using different techniques according to rest and contraction intervals. Pain levels were assessed using the VAS before and after massage. After the massage, the exercise session began; the pregnant woman was first walked along a 50-metre corridor, followed by squatting, squat, four-legged positions, wall stretching movements, and pelvic tilt, swaying, and leg stretching exercises using a Pilates ball. Pain levels were measured using the VAS before and after all exercise applications.

1. Intervention Group 1 - Exercise Programme

Hot Shower Programme BEHAVIORAL

In addition to midwifery care, breathing exercises, massage, and hot showers were administered in this group. Massage was administered for 10 minutes after the breathing exercises, and pain levels were measured using the VAS before and after the massage. After the massage, considering the risk of the pregnant woman falling, she was seated on a stool in the shower, and warm water at a temperature of 36.5-37.8 °C was applied to the lower abdomen and sacrum region during contractions for 15 minutes. To prevent chills, the application was repeated at 10-minute intervals, and pain levels before and after were again assessed using the VAS.

2. Intervention Group 2 - Hot Shower Programme

Combined Application (Exercise + Hot Shower) BEHAVIORAL

In addition to midwifery care, breathing exercises, massage, exercise and hot shower treatments were performed for this group. As in Groups 1 and 2, the application began with breathing exercises, followed by massage, exercise, and hot showers in sequence. Pain levels were assessed using the VAS before and after each application, and measurements were taken again during the massage. Ten-minute breaks were given between applications to allow the pregnant women to rest, and the applications were continued alternately.

3. Intervention Group 3 - Combined Application (Exercise + Hot Shower)

Pharmacological Intervention BEHAVIORAL

In this study, the fourth group was evaluated as the intervention 4 group and was followed up in accordance with standard interventions frequently applied during the birth process. Pregnant women in this group received routine midwifery care, massage treatments to promote relaxation, and breathing exercises in accordance with hospital protocols. In addition, pharmacological pain management methods commonly used in the clinic were also applied in this group.

4. Intervention Group - Pharmacological Intervention

Eligibility Criteria

• Age: 18 Days - 45 Days
• Gender Eligibility Details: The study was conducted on primiparous pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Multiparity,
• High-risk pregnancies were not included in the study sample.

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Üsküdar Üniversitesi Sağlık Bilimleri Fakültesi, İstanbul, Ümraniye 34662

Istanbul, Ümraniye, 34662, Turkey (Türkiye)

Location

Related Links

• Gong, M., Dong, H., Tang, Y., Huang, W., \& Lu, F. (2020). Aromaterapinin kaygı üzerindeki etkileri: Randomize kontrollü denemelerin meta analizi. Duygusal Bozukluklar Dergisi, 274, 1028-1040.
• Uysal, C., Boz, İ., \& Salman, S. (2022). Doğum Eyleminin Aktif Fazında Yaşanan Bel Ağrısının Yönetiminde Steril Su Enjeksiyonunun Etkisi: Randomize, Plasebo Kontrollü Bir Çalışma. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 15(2), 1

MeSH Terms

Conditions

Labor Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: The study sample was divided into four groups: Group 1 - Intervention Group - (midwife monitoring during labour, breathing exercises, exercise and massage), Group 2 - Intervention Group - (midwife monitoring during labour, breathing exercises, massage and hot shower), Group 3 intervention group (midwife monitoring during labour, breathing exercises, exercise, massage and hot shower) and 4. intervention group (midwife monitoring during labour and pharmacological interventions). Data were collected face-to-face with a single midwife.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 11, 2025
• Study Start: January 27, 2023
• Primary Completion: February 12, 2024
• Study Completion: May 28, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The work started in January 2023 and ended in May 2025.
• Access Criteria: The study can be accessed by entering Yöktez and typing the name of the study or the names of the administrators.

Locations

TU (1)