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Completed

NCT Number: NCT07060339

Effect of Nonpharmacological Methods on The Active Phase Of Labour

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.

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Key information

Conditions

Labour Pains Behavior Exercise Labor Pain Massage Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 day–45 day

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Üsküdar Üniversitesi Sağlık Bilimleri Fakültesi, İstanbul, Ümraniye 34662

Istanbul, Ümraniye, 34662, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Criteria for Inclusion in the Study:

  • 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

for Participants:

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Visual Comparison Scale (Vizual Analogue Scale -VAS)

    Time frame: 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.

  2. Birth Experience Scale (BES)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

The Effect of Pain Coping Methods Used in the Active Phase of Labour on Birth Outcomes

Acronym: EFPCMUAPLBO

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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