- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609838
Effect Of Hot Water Foot Bath Applied İn The Early Period After Cesarean Section On Pain, Fatigue And Gas Release
November 7, 2022 updated by: Oya KAPLAN, University of Gaziantep
The aim of this research is to determine the effect of hot water foot bath applied in the early period after cesarean section on pain, fatigue and gas release.The sample of the research consisted of 80 women who gave birth by cesarean section.
'Descriptive Information Form', 'Numerical Rating Scale', 'Visual Analogue Scale for Fatigue', 'Experimental Group Patient Follow-up Form', 'Control Group Patient Follow-up Form' were used as data collection tools.
It was determined that the hot water foot bath applied in the early period after cesarean section reduced the level of pain and fatigue, and had no effect on gas release.
Study Overview
Detailed Description
The aim of this research is to determine the effect of hot water foot bath applied in the early period after cesarean section on pain, fatigue and gas release.
This research is a randomized controlled trial.
The study was conducted in Gaziantep Abdulkadir Yuksel Hospital.
The sample of the research consisted of 80 women who gave birth by cesarean section (experimental group: 40 and control group: 40).
The women in the study were randomly assigned to the experimental and control groups before starting the application.
The data were collected between 01 December 2021 and 31 June 2022.
'Descriptive Information Form', 'Numerical Rating Scale', 'Visual Analogue Scale for Fatigue', 'Experimental Group Patient Follow-up Form', 'Control Group Patient Follow-up Form' were used as data collection tools.
Hot water foot bath was applied to the experimental group for 15 minutes 3 hours after the cesarean section.
The control group was only followed up after cesarean section.
In the comparison of the experimental and control groups, chi-square for categorical variables, and independent samples t-test for numerical variables were used.
Independent samples t-test was used to compare the scale scores of the experimental and control groups.
In the comparison of the scale scores that were measured at different times, the Repeated Measurements Analysis of Variance was applied and the Least Significant Difference(LSD) test, which is one of the multiple comparison tests, was used.
It was found that the pain level of the women after the hot water foot bath application in the experimental group was lower than that of the control group and the measurements before the application.
It was determined that the fatigue levels of the women in the experimental group after the application were lower than the control group and the measurements before the application.
It was determined that the application of hot water foot bath was not effective in the period of gas release after cesarean section.
As a result, it was determined that the hot water foot bath applied in the early period after cesarean section reduced the level of pain and fatigue, and had no effect on gas release.
During the post-cesarean section, a hot water foot bath can be recommended in nursing care.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gaziantep, Turkey, 27000
- Gaziantep University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- T.C. citizen of
- over 18 years old
- No history of any medical illness
- Receiving spinal anesthesia in cesarean section
- No complications during or after cesarean section
- Those who have not had any problems during pregnancy
- No mental handicap or perception problems and no communication difficulties
- Women who do not release gas before applying a hot water foot bath
Exclusion Criteria:
- Those who have intestinal discomfort during pregnancy and before pregnancy, have undergone intestinal surgery
- Gas-releasing before hot water footbath application
- sensory loss
- Wounds and/or lesions on their feet
- Those with vascular diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
A 15 minutes hot water foot bath was applied to the experimental group patients 3 hours after the cesarean section.Data collection tools were applied at the 5th minute, 1st hour and 2nd hour after the hot water footbath and the gas output was questioned.
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A 15 minutes hot water foot bath was applied to the experimental group patients 3 hours after the cesarean section.
|
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No Intervention: Control Group
The control group was given routine post-cesarean care without any intervention and data collection tools were applied at the same time as the experimental group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The numerical rating scale (NRS)
Time Frame: at the 3rd hour after cesarean section before hot water foot bath application
|
It is a frequently preferred scale because it is thought to be easy to apply.
With this scale, the patient's pain is explained with numerical values.
Pain severity assessment in numerical scales is applied as a rating starting with "0" and up to "10" level.
Here, "0" means no pain, "10" means unbearable pain.
In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers.
|
at the 3rd hour after cesarean section before hot water foot bath application
|
|
The numerical rating scale (NRS)
Time Frame: at the 5th minute after the application of hot water foot bath
|
It is a frequently preferred scale because it is thought to be easy to apply.
With this scale, the patient's pain is explained with numerical values.
Pain severity assessment in numerical scales is applied as a rating starting with "0" and up to "10" level.
Here, "0" means no pain, "10" means unbearable pain.
In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers.
|
at the 5th minute after the application of hot water foot bath
|
|
The numerical rating scale (NRS)
Time Frame: at the 1st hour after the application of hot water foot bath
|
It is a frequently preferred scale because it is thought to be easy to apply.
With this scale, the patient's pain is explained with numerical values.
Pain severity assessment in numerical scales is applied as a rating starting with "0" and up to "10" level.
Here, "0" means no pain, "10" means unbearable pain.
In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers.
|
at the 1st hour after the application of hot water foot bath
|
|
The numerical rating scale (NRS)
Time Frame: at the 2nd hour after the application of hot water foot bath
|
It is a frequently preferred scale because it is thought to be easy to apply.
With this scale, the patient's pain is explained with numerical values.
Pain severity assessment in numerical scales is applied as a rating starting with "0" and up to "10" level.
Here, "0" means no pain, "10" means unbearable pain.
In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers.
|
at the 2nd hour after the application of hot water foot bath
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
'Visual Analogue Scale for Fatigue (VAS-F)
Time Frame: at the 3rd hour after cesarean section before hot water foot bath application
|
The scale consists of 18 items relating to the subjective experience of fatigue.
Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
|
at the 3rd hour after cesarean section before hot water foot bath application
|
|
'Visual Analogue Scale for Fatigue (VAS-F)
Time Frame: at the 5th minute after the application of hot water foot bath
|
The scale consists of 18 items relating to the subjective experience of fatigue.
Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
|
at the 5th minute after the application of hot water foot bath
|
|
'Visual Analogue Scale for Fatigue (VAS-F)
Time Frame: at the 1st hour after the application of hot water foot bath
|
The scale consists of 18 items relating to the subjective experience of fatigue.
Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
|
at the 1st hour after the application of hot water foot bath
|
|
'Visual Analogue Scale for Fatigue (VAS-F)
Time Frame: at the 2nd hour after the application of hot water foot bath
|
The scale consists of 18 items relating to the subjective experience of fatigue.
Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired").
|
at the 2nd hour after the application of hot water foot bath
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oya KAPLAN, PhD Student, University of Gaziantep
- Principal Investigator: Simge ZEYNELOĞLU, Professor, University of Gaziantep
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
November 1, 2022
First Submitted That Met QC Criteria
November 7, 2022
First Posted (Actual)
November 8, 2022
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 7, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGaziantep-SBF-OK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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