The Effect of Foot Bath on Birth Pain and Birth Comfort

NCT06380400 | Completed

• 1 other identifier: 0000-0001-5786-4385
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women.

Conditions

Parturition

Keywords

Birth; Labour; Footbath; Birth pain; Birth comfort

Outcome Measures

Primary Outcomes (1)

• Visuell analog scale score of the pregnant woman

  Pain levels of pregnant women will be assessed. On one side of the scale there is a line labelled 'no pain' and on the other side there is a line labelled 'severe pain' and on the side immediately behind this line there is a scale divided into 10 equal intervals. The higher the score, the greater the intensity of the pain.

  within the first 24 hours after the time of the birth of the baby

Secondary Outcomes (1)

• Birth comfort scale score of the pregnant woman

  within the first 24 hours after the time of the birth of the baby

Study Arms (2)

Foot bath intervention group

EXPERIMENTAL

Pregnant women are given a foot bath during the first stage of labour.

Behavioral: Foot bath

Routine midwifery care control group

NO INTERVENTION

Pregnant women receive routine midwifery care during the first stage of labour.

Interventions

Foot bath BEHAVIORAL

Pregnant women were given footbaths for 20 minutes during the active phase of the first stage of labour (after cervical dilatation of 4 cm) and 20 minutes during the transitional phase of the second stage of labour (cervical dilatation of 9 cm). Pregnant women who completed two footbath sessions were assessed for pain using the visual comparison scale. In addition, the data collection process will be completed by applying the Birth Comfort Scale after the two stages of labour.

Foot bath intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primipar pregnancy
• and 42 weeks
• Cervical dilation at least 4 cm
• Head presentation
• Over 18 years of age
• Pregnant women who agreed to participate after being informed about the study

You may not qualify if:

• People with communication difficulties and mental disabilities
• Any risk condition related to pregnancy (pre-eclampsia, gestational diabetes, anomalies of presentation, anomalies related to the placenta)
• Development of maternal-fetal complications
• Use of anticoagulant therapy
• Pregnant women with a diagnosed psychiatric illness will be excluded from the study.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Habibe Bay Ozcalik

Konya, 42250, Turkey (Türkiye)

Location

Study Officials

• Habibe Bay Ozcalik

  Selcuk University

  PRINCIPAL INVESTIGATOR

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: Assist prof.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 23, 2024
• Study Start: February 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)