Cesarean Section PainNCT06793293
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
A study testing High level laser and Non-steroidal anti- inflammatory drugs and antibiotics in people with Cesarean Section Pain, run by Cairo University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Pain
- What is being tested?
- High level laser and Non-steroidal anti- inflammatory drugs and antibiotics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Cesarean Section Pain
- Being tested
- High level laser, Non-steroidal anti- inflammatory drugs and antibiotics
- Keywords
- cesarean section pain, High power laser, decreasing pain, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High level laserDevice
Also called High power 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)
Non-steroidal anti- inflammatory drugs and antibioticsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| High level laser | Experimental | 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) Receives: Device: High level laser |
| (Non-steroidal anti- inflammatory drugs and antibiotics) | Active comparator | 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. Receives: Drug: Non-steroidal anti- inflammatory drugs and antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS):
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.
Measured: third day
Blood test
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.
Measured: third day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Oct 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- High power level laser used after cesarian section to decrease pain for 3 sessions first, second and third day.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ibrahim Awad Shweal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793293
- Sponsor's protocol ID
- P.T.Rec/012/005570
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Level Laser Therapy on Postoperative Cesarean Section Incisional Pain
- ClinicalTrials.gov ID
- NCT06793293
- Acronym / sponsor ID
- P.T.Rec/012/005570
- Conditions
- Cesarean Section Pain
- Keywords
- cesarean section pain, High power laser, decreasing pain, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 27 Jan 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- High power level laser used after cesarian section to decrease pain for 3 sessions first, second and third day.
| Arm | Type | Receives |
|---|---|---|
| High level laser | Experimental | Device: High level laserIt 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) |
| (Non-steroidal anti- inflammatory drugs and antibiotics) | Active comparator | Drug: Non-steroidal anti- inflammatory drugs and antibioticsIt 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
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 |
|---|---|---|
| High level laserAlso: High power laserIt 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) | Device | High level laser |
| Non-steroidal anti- inflammatory drugs and antibioticsIt 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. | Drug | (Non-steroidal anti- inflammatory drugs and antibiotics) |
Primary outcome
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.
Blood test
Time frame: third day
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- High power laserLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section Pain
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High level laser and Non-steroidal anti- inflammatory drugs and antibiotics in people with Cesarean Section Pain, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 27 Jan 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual analog scale (VAS): (time frame: third day). The study lists 2 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 27 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.