NCT06793293

Brief 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 16, 2025

Last Update Submit

January 23, 2025

Conditions

Keywords

cesarean section painHigh power laserdecreasing painPostoperative pain

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    third day

Study Arms (2)

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)

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.

Drug: Non-steroidal anti- inflammatory drugs and antibiotics

Interventions

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)

Also known as: High power laser
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) only.

(Non-steroidal anti- inflammatory drugs and antibiotics)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • \. 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: High power level laser used after cesarian section to decrease pain for 3 sessions first, second and third day.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teacher assistance at faculty of physical therapy

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 27, 2025

Study Start

October 1, 2024

Primary Completion

April 30, 2025

Study Completion

May 15, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations