- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06793293
Postoperative in Cesarean Section, the Women Suffering from Pain Due to Wound "incisional Pain", High Level Laser One of Most Effective Methods That Promoting Healing and Decrease Pain so It Will Effective If Use in Decreasing Pain of Cesarian Section
January 23, 2025 updated by: Aya Ibrahim Awad Shweal, Cairo University
Effect of High Level Laser Therapy on Postoperative Cesarean Section Incisional Pain
High power laser is safe and effective methods, it's uses increasing one day after day in decreasing pain and promoting healing so its use in postoperative cesarian section will help mothers to overcome pain and return to ADLs faster
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Cairo, Egypt
- Cairo University
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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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Their ages will be ranged from 20-40 years. 2. Their BMI will be less than 30 Kg\m 2 3. Patients with lower segment cesarean section (Poursalehan et al., 2018 & de Holanda et al., 2020).
Exclusion Criteria:
- 1. Patients with upper segment cesarean section. 2. Diabetic patient. 3. Patient with malignancy, benign tumors with the possibility to become malignant. 4. Infection of the skin (Poursalehan et al., 2018).
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High level laser
It will be consisted of twenty-five postoperative cesarean section women and will be treated by medical treatment (Non-steroidal anti- inflammatory drugs and antibiotics) in addition to High level laser for 5 minutes on days 1 st , 2 nd , and 3 rd , after cesarean section (3 sessions)
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It will be consisted of twenty-five postoperative cesarean section women and will be treated by medical treatment (Non-steroidal anti- inflammatory drugs and antibiotics) in addition to High level laser for 5 minutes on days 1 st , 2 nd , and 3 rd , after cesarean section (3 sessions)
Other Names:
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Active Comparator: (Non-steroidal anti- inflammatory drugs and antibiotics)
It will be consisted of twenty-five postoperative cesarean section women and will be treated by medical treatment (Non-steroidal anti- inflammatory drugs and antibiotics) only.
|
It will be consisted of twenty-five postoperative cesarean section women and will be treated by medical treatment (Non-steroidal anti- inflammatory drugs and antibiotics) only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale (VAS):
Time Frame: third day
|
It will be used to assess the severity of low back pain in women from both groups A and B before and after treatment.
The scoring ranges from 1, indicating the least pain and discomfort, to 10, representing the most severe pain and discomfort.
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third day
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Blood test
Time Frame: third day
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Serum cortisol test (percentage of cortisol level in blood): It will take in the morning for two times one before the intervention or treatment in both groups and another one after 3 days to asses the pain level for patient.
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third day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (Actual)
October 1, 2024
Primary Completion (Estimated)
April 30, 2025
Study Completion (Estimated)
May 15, 2025
Study Registration Dates
First Submitted
January 16, 2025
First Submitted That Met QC Criteria
January 23, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 23, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.Rec/012/005570
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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