- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06380400
The Effect of Foot Bath on Birth Pain and Birth Comfort
The Effect of Foot Bath on Birth Pain and Birth Comfort in the First Stage of Labour
Study Overview
Detailed Description
The purpose of the study will be explained to pregnant women found to meet the inclusion criteria, and written informed consent will be obtained from participants who volunteer for the study. Participants will be randomly divided into two groups (group 1: intervention group, group 2: control group). Pregnant women will be allocated to the intervention and control groups according to the randomisation scheme to be generated from the random.org website. The personal information form will be used for both intervention and control groups.
Intervention group Pregnant women in the intervention group will receive footbaths for 20 minutes during the active phase of the first stage of labour (after 4 cm cervical dilation) and 20 minutes during the transitional phase of the second stage of labour (9 cm cervical dilation). 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 two stages of labour.
Control group The process of applying the data collection tools to the pregnant women in the control group is the same as for the intervention group. The pregnant women in the control group will be subjected to the routine practices of the hospital without foot bathing.
Warm water foot bath:
The warm water footbath is performed in 4 steps. Before starting the treatment, warm water is poured into the bucket in which the footbath will take place and the water temperature is set at 41-42°C using a thermometer. In the first stage of the application, the room temperature is between 22 and 25°C. In the second stage, the applicants are made to sit in a chair or armchair. In the third stage, they are allowed to dip their feet into the warm water footbath bucket, where the water temperature is kept between 41 and 42°C, up to the level of the ankles. They are asked to remain in this position for 20 minutes. The temperature of the water is checked between applications and hot water is added when the water cools down. At the end of the treatment, the feet are taken out of the water and dried with a towel. The towel should be left on for 5-7 minutes to allow the heat to work for a while.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Konya, Turkey, 42250
- Habibe Bay Ozcalik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primipar pregnancy
- 37 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Foot bath intervention group
Pregnant women are given a foot bath during the first stage of labour.
|
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.
|
|
No Intervention: Routine midwifery care control group
Pregnant women receive routine midwifery care during the first stage of labour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visuell analog scale score of the pregnant woman
Time Frame: within the first 24 hours after the time of the birth of the baby
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Birth comfort scale score of the pregnant woman
Time Frame: within the first 24 hours after the time of the birth of the baby
|
Pregnant women's comfort during childbirth will be assessed.
The minimum score that can be obtained from the scale is 14 and the maximum score is 70.
The higher the score, the higher the level of comfort.
|
within the first 24 hours after the time of the birth of the baby
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Habibe Bay Ozcalik, Selcuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0000-0001-5786-4385
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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