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Effect Of Hot Water Foot Bath Applied İn The Early Period After Cesarean Section On Pain, Fatigue And Gas Release

Primary Purpose

Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hot water foot bath
Sponsored by
University of Gaziantep
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cesarean Section focused on measuring Nursing, cesarean section, pain, fatigue

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gaziantep University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The numerical rating scale (NRS)
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.
The numerical rating scale (NRS)
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.
The numerical rating scale (NRS)
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.
The numerical rating scale (NRS)
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.

Secondary Outcome Measures

'Visual Analogue Scale for Fatigue (VAS-F)
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").
'Visual Analogue Scale for Fatigue (VAS-F)
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").
'Visual Analogue Scale for Fatigue (VAS-F)
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").
'Visual Analogue Scale for Fatigue (VAS-F)
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").

Full Information

First Posted
November 1, 2022
Last Updated
November 7, 2022
Sponsor
University of Gaziantep
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1. Study Identification

Unique Protocol Identification Number
NCT05609838
Brief Title
Effect Of Hot Water Foot Bath Applied İn The Early Period After Cesarean Section On Pain, Fatigue And Gas Release
Official Title
Effect Of Hot Water Foot Bath Applied İn The Early Period After Cesarean Section On Pain, Fatigue And Gas Release
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gaziantep

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section
Keywords
Nursing, cesarean section, pain, fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups (experimental group and control group)
Masking
Participant
Masking Description
The researcher knew which of the participants belonged to the experimental and control groups, but the participants did not know. It is a single-blind study.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hot water foot bath
Intervention Description
A 15 minutes hot water foot bath was applied to the experimental group patients 3 hours after the cesarean section.
Primary Outcome Measure Information:
Title
The numerical rating scale (NRS)
Description
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.
Time Frame
at the 3rd hour after cesarean section before hot water foot bath application
Title
The numerical rating scale (NRS)
Description
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.
Time Frame
at the 5th minute after the application of hot water foot bath
Title
The numerical rating scale (NRS)
Description
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.
Time Frame
at the 1st hour after the application of hot water foot bath
Title
The numerical rating scale (NRS)
Description
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.
Time Frame
at the 2nd hour after the application of hot water foot bath
Secondary Outcome Measure Information:
Title
'Visual Analogue Scale for Fatigue (VAS-F)
Description
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").
Time Frame
at the 3rd hour after cesarean section before hot water foot bath application
Title
'Visual Analogue Scale for Fatigue (VAS-F)
Description
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").
Time Frame
at the 5th minute after the application of hot water foot bath
Title
'Visual Analogue Scale for Fatigue (VAS-F)
Description
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").
Time Frame
at the 1st hour after the application of hot water foot bath
Title
'Visual Analogue Scale for Fatigue (VAS-F)
Description
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").
Time Frame
at the 2nd hour after the application of hot water foot bath

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oya KAPLAN, PhD Student
Organizational Affiliation
University of Gaziantep
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simge ZEYNELOĞLU, Professor
Organizational Affiliation
University of Gaziantep
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziantep University
City
Gaziantep
ZIP/Postal Code
27000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect Of Hot Water Foot Bath Applied İn The Early Period After Cesarean Section On Pain, Fatigue And Gas Release

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