Cesarean SectionNCT05609838
Effect Of Hot Water Foot Bath Applied İn The Early Period After Cesarean Section On Pain, Fatigue And Gas Release
A study testing Hot water foot bath in people with Cesarean Section, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Hot water foot bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cesarean Section
- Being tested
- Hot water foot bath
- Keywords
- Nursing, cesarean section, pain, fatigue
- Medical subject headings
- Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot water foot bathOther
A 15 minutes hot water foot bath was applied to the experimental group patients 3 hours after the cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: Hot water foot bath |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the 3rd hour after cesarean section before hot water foot bath application
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.
Measured: at the 5th minute after the application of hot water foot bath
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.
Measured: at the 1st hour after the application of hot water foot bath
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.
Measured: at the 2nd hour after the application of hot water foot bath
Secondary outcomes (4)
'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").
Measured: at the 3rd hour after cesarean section before hot water foot bath application
'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").
Measured: at the 5th minute after the application of hot water foot bath
'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").
Measured: at the 1st hour after the application of hot water foot bath
'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").
Measured: at the 2nd hour after the application of hot water foot bath
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Dec 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups (experimental group and control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oya KAPLAN, University of Gaziantep
- Investigators
- Oya KAPLAN, PhD Student, Principal investigator, University of GaziantepSimge ZEYNELOĞLU, Professor, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609838
- Sponsor's protocol ID
- UGaziantep-SBF-OK-01
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Hot Water Foot Bath Applied İn The Early Period After Cesarean Section On Pain, Fatigue And Gas Release
- ClinicalTrials.gov ID
- NCT05609838
- Acronym / sponsor ID
- UGaziantep-SBF-OK-01
- Conditions
- Cesarean Section
- Keywords
- Nursing, cesarean section, pain, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups (experimental group and control group)
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Hot water foot bathA 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot water foot bathA 15 minutes hot water foot bath was applied to the experimental group patients 3 hours after the cesarean section. | Other | Experimental group |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
'Visual Analogue Scale for Fatigue (VAS-F)
Time frame: 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
'Visual Analogue Scale for Fatigue (VAS-F)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oya KAPLAN, PhD Student principal investigator
University of Gaziantep
Simge ZEYNELOĞLU, Professor principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot water foot bath in people with Cesarean Section, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The numerical rating scale (NRS) (time frame: at the 3rd hour after cesarean section before hot water foot bath application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.