Effect of Nonpharmacological Methods on The Active Phase Of Labour

NCT ID: NCT07060339

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-27
• Study Completion Date: 2025-05-28

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.

Conditions

Labour Pains; Massage; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

1. Intervention Group 1 - Exercise Programme

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.

Group Type: EXPERIMENTAL

Exercise Programme

Intervention Type: 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.

2. Intervention Group 2 - Hot Shower Programme

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.

Group Type: EXPERIMENTAL

Hot Shower Programme

Intervention Type: 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.

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

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.

Group Type: EXPERIMENTAL

Combined Application (Exercise + Hot Shower)

Intervention Type: 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.

4. Intervention Group - Pharmacological Intervention

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.

Group Type: EXPERIMENTAL

Pharmacological Intervention

Intervention Type: 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.

Interventions

Exercise Programme

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.

Intervention Type: BEHAVIORAL

Hot Shower Programme

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.

Intervention Type: BEHAVIORAL

Combined Application (Exercise + Hot Shower)

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.

Intervention Type: BEHAVIORAL

Pharmacological Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• In labour,
• Nulliparous,
• Cervical dilation greater than 3 cm,
• Full-term pregnancy (between 38 and 42 weeks of gestation),
• Carrying a single live foetus. *Reason for selecting nulliparous women: Multiparous women were excluded to randomise birth memory and avoid influencing case outcomes, as previous birth experiences may influence pain perception and birth experience.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Days
• Maximum Eligible Age: 45 Days
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

Tuğba YILMAZ ESENCAN

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Üsküdar Üniversitesi Sağlık Bilimleri Fakültesi, İstanbul, Ümraniye 34662

Istanbul, Ümraniye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Study Documents

Document Type: Individual Participant Data Set

https://dergipark.org.tr/tr/pub/ausbid/issue/38415/445612

View Document

Related Links

https://doi.org/10.1016/j.jad.2020.05.118

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.

https://doi.org/10.46483/deuhfed.978831

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

Other Identifiers

2023-2/27

Identifier Type: -

Identifier Source: org_study_id