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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Gaziantep, Turkey, 27000
        • Gaziantep University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Hot water foot bath
A 15 minutes hot water foot bath was applied to the experimental group patients 3 hours after the cesarean section.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Gaziantep

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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