- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05799547
The Effect of Cold Application on Patient's Pain, Comfort and Satisfaction After Cesarean Section
April 4, 2023 updated by: Emine Yıldırım, Osmaniye Korkut Ata University
The Effect of Cold Application on the Pain, Comfort and Satisfaction of the Patient on First Standing After Cesarean Section
A healthy postpartum period is important for the health of the mother and baby.
One of the main problems that occur after cesarean section, which is a major surgical procedure, is pain.
However, since the mother is in the postpartum period, she may have problems in her own care, healing process and baby care due to pain.
Non-pharmacological treatment is methods such as massage, acupressure, hot and cold application that can be applied at birth to support scientific medicine.
The cold application examined in our research, is among these applications.
participants will be determined by the block randomization method.
Cold application will be applied to the cesarean section site of the patient for 10 minutes in the experimental group, followed by a break of 20 minutes, followed by a 10-minute application, and immediately after the application, the patient will stand up.
Only the routine practice of the clinic will be applied to the control group.
Data; will be collected using the introductory information form, visual analog scale (VAS) and cold application satisfaction evaluation form.
When the studies were examined, no other study was found in the same application as our study.
Therefore, in this study, it was aimed to evaluate the effect of cold application on the patient's pain during the first leg, the need for painkillers and satisfaction, due to the higher first take-off pain after cesarean section.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Postpartum women who had cesarean section surgery
- Having had a previous cesarean section,
Exclusion Criteria:
- Those who have problems in postpartum vital signs and bleeding control
- Those who have systemic diseases that may affect cold application
- Those who are distressed and not suitable for practice by the service midwives and doctors,
- Those who do not want to participate in the research
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 |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
|
Application will be made in the form of 10 minutes of application to the cesarean section incision, 20 minutes of break and 10 minutes of application.
|
|
No Intervention: control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analog scale (VAS)
Time Frame: 1 week
|
The visual analog scale is used to assess pain.
The person marks the pain he feels on a ten-centimeter chart that expresses the absence of pain on one side and the pain he feels at the peak on the other side.
|
1 week
|
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)
June 20, 2023
Primary Completion (Anticipated)
July 10, 2023
Study Completion (Anticipated)
August 20, 2023
Study Registration Dates
First Submitted
January 10, 2023
First Submitted That Met QC Criteria
April 4, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 55555
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.