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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05609838
Other study ID # UGaziantep-SBF-OK-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date June 30, 2022

Study information

Verified date November 2022
Source University of Gaziantep
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Gaziantep University Gaziantep

Sponsors (1)

Lead Sponsor Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at the 3rd hour after cesarean section before hot water foot bath application
Primary 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. at the 5th minute after the application of hot water foot bath
Primary 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. at the 1st hour after the application of hot water foot bath
Primary 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. at the 2nd hour after the application of hot water foot bath
Secondary '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"). at the 3rd hour after cesarean section before hot water foot bath application
Secondary '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"). at the 5th minute after the application of hot water foot bath
Secondary '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"). at the 1st hour after the application of hot water foot bath
Secondary '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"). at the 2nd hour after the application of hot water foot bath
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