- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05560347
The Effect of Hot Water After Cesarean Section
September 28, 2022 updated by: Tugba Sivri, Marmara University
The Effect of Hot Water Application on Pain, Comfort and Vital Singns After Cesarean
The main subject of this project is the problem of pain after cesarean section.
It is known that the application of hot water reduces the pain of the patients, with the decrease of the pain, the vital signs of the patient are improved and the comfort level increases.
Our project work is based on this subject.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Cesarean section surgery is an attempt to become mandatory and applied in cases where vaginal delivery is dangerous for the mother and fetus.
One of the most common problems that women experience in the process after cesarean section is pain.
This pain experienced for various reasons such as incision site pain, headache and pain caused by uterine contractions negatively affects the comfort of the woman in the postpartum period.
In addition to pain, especially after cesarean section, the woman cannot be mobilized, the presence of a urinary catheter, the negative effects caused by anesthesia cause the mother to be unable to meet her own self-care needs and perform life activities, which disrupts the comfort of the woman As a result of the study in which Çankaya evaluated the comfort of mothers who gave birth by cesarean section, it was found that 78% of mothers have pain at the incision site and this negatively affects maternal comfort The pain that cannot be controlled causes a limitation in activities, respiratory, circulatory and digestive system problems in the postoperative period and prolongs the recovery period.
Therefore, the woman's pain should be managed and aimed at minimizing it.
In this context, when looking at the literature, it is noticeable that there are various methods of dealing with pain after cesarean section.
Pharmacological treatment options are preferred in the management of pain after cesarean section due to their ability to reduce and treat pain in a shorter period of time.
After cesarean section, more often non-steroidal anti-inflammatory drugs or paracetamol-derived drugs are used.
Non-pharmacological methods should also be used in pain management to support pharmacological methods and minimize the use of analgesics Some non-pharmacological methods used can be listed as follows; aromatherapy, massage hand/foot massage, listening to music, progressive relaxation exercises, acupuncture, hot and cold applications.
A limited number of studies on hot application have been found in the literature.
Based on these results, this study is planned to examine the effects of hot water application on pain comfort and life signs.
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
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 49 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria
- At least primary school graduate
- 18 years and older
- No history of chronic disease (Diabetes, etc.)
- Risky pregnancy (Premature rupture of membranes, Premature birth threat, preeclampsia etc.) without diagnosis
- Women who do not develop any complications (Atony, abnormal bleeding, need for blood transfusion, risks related to anesthesia, bladder injury, etc.) during or after the operation.
Exclusion Criteria:
- Not a primary school graduate
- Under 18 years old
- Blood pressure, diabetes, etc. sick
- Diagnosed with risky pregnancy,
- Complications developing during or after surgery
- Women who do not want to participate in the study.
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Group
Hot water will be applied to the participants in the experimental group at the 2nd and 6th hours postoperatively.
During the hot water application, the feet of the individual will be immersed in the hot water application device and kept in the device for 20 minutes.
At the end of the 20th minute, the feet of the individual will be removed from the device and dried with a towel for 10 minutes and the application will be completed.
The data will be obtained by using the Introductory Information Form, Visual Analog Scale (VAS), Postpartum Comfort Scale and Post Cesarean Patient Evaluation Form.
|
Hot application is applied by contacting any part of the body with a temperature of 40-45 degrees.
Hot application stimulates the touch receptors and has a vasodilation effect.
Thermoreceptors in the foot are stimulated by applying heat to the feet, and this stimulation is thought to be effective in reducing the activation of the sympathetic nervous system and thus reducing pain.
|
NO_INTERVENTION: Control Group
Routine care will be given to the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain assessed by VAS score
Time Frame: 3rd and 6th hours after cesarean section
|
Chancing in pain after cesarean section.
The data will be obtained by using Visual Analog Scale.
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
|
3rd and 6th hours after cesarean section
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change the comfort score
Time Frame: 12 th hours after cesarean section
|
Chancing the comfort score after cesarean section.
The data will be obtained by using the Postpartum Comfort Scale.
Postpartum Comfort Scale (PCS): It is a Likert-type scale consisting of 34 items to determine the postpartum comfort.
The lowest and the highest scores in the scale are 34 and 170.
It has three sub dimensions; physical, psycho spiritual and sociocultural.
Scores close to 170 indicate ahigh level of comfort.
|
12 th hours after cesarean section
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
October 15, 2022
Primary Completion (ANTICIPATED)
March 15, 2023
Study Completion (ANTICIPATED)
June 15, 2023
Study Registration Dates
First Submitted
September 20, 2022
First Submitted That Met QC Criteria
September 28, 2022
First Posted (ACTUAL)
September 29, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 29, 2022
Last Update Submitted That Met QC Criteria
September 28, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0920211278
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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