Effect of Nonpharmacological Methods on The Active Phase Of Labour (EFPCMUAPLBO)

Uskudar University

Status: Completed

Conditions: Hot Shower; Massage; Non-pharmacological Methods; Active Phase of Labour; Labour Pains; Exercise; Pharmacological Methods

Treatments: Behavioral: Combined Application (Exercise + Hot Shower); Behavioral: Pharmacological Intervention; Behavioral: Hot Shower Programme; Behavioral: Exercise Programme

Study type: Interventional

Funder types: Other

Identifiers

NCT07060339

2023-2/27

Details and patient eligibility

About

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.

Full 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 (Appendix 1); the Informative Information Form developed by the researchers in line with the literature (Gönenç, 2013; Güneş, 2021; Yalçın, Özbaşaran, 2021) Information Form (Appendix 2), the Birth Monitoring Form used during childbirth (Appendix 3), the Visual Analogue Scale - VAS (Appendix 4), the Postpartum Assessment Form (Appendix 5), and the Birth Experience Scale (Appendix 6).

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

1. Intervention Group 1 - Exercise Programme

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Programme

2. Intervention Group 2 - Hot Shower Programme

Experimental group

Description:

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.

Treatment:

Behavioral: Hot Shower Programme

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

Experimental group

Description:

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.

Treatment:

Behavioral: Combined Application (Exercise + Hot Shower)

4. Intervention Group - Pharmacological Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Pharmacological Intervention