- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07501390
Effectiveness Of Early Bed Mobility Exercises And Ambulation In Post Operative Cesarean Section Pain Reduction
Effectiveness Of Early Bed Mobility Exercises And Ambulation In Post Operative Cesarean Section Pain Reduction: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a single-blind randomized controlled trial designed to investigate the effectiveness of early bed mobility exercises and ambulation in reducing post-operative pain among women undergoing elective cesarean section. The study will be conducted at the Department of Gynecology and Obstetrics, Lady Reading Hospital (MTI), Peshawar, over a period of six months.
A total of 56 participants aged 18-40 years who meet the inclusion criteria will be recruited and randomly assigned into two groups using consecutive blocked randomization. The intervention group will receive a structured physiotherapy program including pelvic rolling, leg sliding, deep breathing, chest expansion exercises, ankle pumping, and ambulation starting 5 hours post-surgery. The control group will receive routine nursing care.
Pain intensity will be assessed using the Visual Analog Scale (VAS) and Numerical Pain Rating Scale (NPRS) before and after the intervention. Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 25, applying paired and independent t-tests to compare within and between group differences.
The study aims to demonstrate that early mobilization significantly reduces post-operative pain, decreases the need for analgesics, shortens hospital stay, and improves functional recovery and overall well-being in post-cesarean women.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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KPK
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Peshawar, KPK, Pakistan, 25000
- Lady Reading Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women undergoing elective cesarean section
- Age between 18-40 years
- Medically stable patients
- Patients admitted and staying in hospital for at least 24 hours post-surgery
- Willing to participate and provide informed consent
Exclusion Criteria:
- History of previous abdominal surgeries (e.g., hernia, cholecystectomy)
- Presence of comorbidities such as diabetes, rheumatoid arthritis, or long-term steroid use
- Patients with severe postpartum complications (e.g., hemorrhage, deep vein thrombosis, pulmonary embolism)
- Patients experiencing severe nausea, dizziness, or vomiting
- Patients unable to follow instructions
- Patients unwilling to participate
Study Plan
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: Early Bed Mobility Exercises and Ambulation
Participants in this group will receive a structured physiotherapy program starting 5 hours after cesarean section.
The intervention includes pelvic rolling, leg sliding, deep breathing exercises, pursed-lip breathing, chest expansion exercises, huffing and coughing techniques, ankle pumping, abdominal wall setting, and early ambulation.
Exercises will be performed 3 times daily with 10-12 repetitions per session from the day of surgery until discharge.
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A structured physiotherapy program initiated 5 hours after cesarean section, including mobility and breathing exercises along with early ambulation, administered multiple times daily until discharge to improve recovery and reduce post-operative pain.
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Active Comparator: Routine Postoperative Nursing Care
Participants in this group will receive routine post-operative nursing care as per hospital protocol without any structured physiotherapy exercise program.
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Standard postoperative care provided according to hospital protocol without any additional structured physiotherapy or mobilization program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Postoperative Pain Intensity
Time Frame: Baseline (within 5 hours post-surgery) and at discharge (3-5 days post-surgery)
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Pain intensity will be measured using the Visual Analog Scale (VAS), a continuous scale ranging from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate worse pain intensity.
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Baseline (within 5 hours post-surgery) and at discharge (3-5 days post-surgery)
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Time to First Ambulation
Time Frame: Within 24-48 hours post-surgery
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Time to first ambulation will be defined as the time (in hours) from the end of surgery to the participant's ability to walk independently without assistance.
Shorter time indicates better recovery.
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Within 24-48 hours post-surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Functional Recovery Status
Time Frame: Baseline (post-surgery) and at discharge (3-5 days)
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Functional recovery will be assessed using the Barthel Index of Activities of Daily Living (ADL), which measures independence in activities such as sitting, standing, and walking.
The scale ranges from 0 (total dependence) to 100 (complete independence), with higher scores indicating better functional recovery.
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Baseline (post-surgery) and at discharge (3-5 days)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Syeda Wajeeha, MS, Lady Reading Hospital Peshawar
Publications and helpful links
General Publications
- Citak Karakaya I, Yuksel I, Akbayrak T, Demirturk F, Karakaya MG, Ozyuncu O, Beksac S. Effects of physiotherapy on pain and functional activities after cesarean delivery. Arch Gynecol Obstet. 2012 Mar;285(3):621-7. doi: 10.1007/s00404-011-2037-0. Epub 2011 Aug 10.
- Weerasinghe K, Rishard M, Brabaharan S, Mohamed A. Effectiveness of face-to-face physiotherapy training and education for women who are undergoing elective caesarean section: a randomized controlled trial. Arch Physiother. 2022 Feb 3;12(1):4. doi: 10.1186/s40945-021-00128-9.
- Weerasinghe K, Rishard M, Brabaharan S, Walpita Y. Physiotherapy training and education prior to elective Caesarean section and its impact on post-natal quality of life: a secondary analysis of a randomized controlled trial. BMC Res Notes. 2023 Oct 13;16(1):270. doi: 10.1186/s13104-023-06550-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
- Locomotion
- Walking
Other Study ID Numbers
- 82/LRH/MTI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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