NCT07501390

Brief Summary

This study aims to evaluate the effectiveness of early bed mobility exercises and ambulation in reducing post-operative pain among women who undergo elective cesarean section. A randomized controlled trial will be conducted with 56 participants divided into intervention and control groups. The intervention group will receive physiotherapy exercises such as pelvic rolling, breathing exercises, and ambulation, while 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). The study is expected to show that early mobilization reduces pain, improves recovery, and enhances overall well-being.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 17, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Pain ReductionPostnatal ExercisesPostoperative PainEarly MobilizationPhysiotherapy

Outcome Measures

Primary Outcomes (2)

  • Change in Postoperative Pain Intensity

    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.

    Baseline (within 5 hours post-surgery) and at discharge (3-5 days post-surgery)

  • Time to First Ambulation

    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.

    Within 24-48 hours post-surgery

Secondary Outcomes (1)

  • Change in Functional Recovery Status

    Baseline (post-surgery) and at discharge (3-5 days)

Study Arms (2)

Early Bed Mobility Exercises and Ambulation

EXPERIMENTAL

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.

Procedure: Early Bed Mobility Exercises and Ambulation

Routine Postoperative Nursing Care

ACTIVE COMPARATOR

Participants in this group will receive routine post-operative nursing care as per hospital protocol without any structured physiotherapy exercise program.

Other: Routine Nursing Care

Interventions

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.

Early Bed Mobility Exercises and Ambulation

Standard postoperative care provided according to hospital protocol without any additional structured physiotherapy or mobilization program.

Routine Postoperative Nursing Care

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Reading Hospital

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 21830007BACKGROUND
  • 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.

    PMID: 35109917BACKGROUND
  • 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.

    PMID: 37833802BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Walking

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Dr Syeda Wajeeha, MS

    Lady Reading Hospital Peshawar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study will follow a single-blind design in which the outcome assessor will be blinded to group allocation. Participants and care providers will be aware of the assigned interventions, but the assessor responsible for measuring outcomes (VAS and NPRS) will remain unaware to reduce bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into two groups, an intervention group receiving physiotherapy exercises (early bed mobility and ambulation) and a control group receiving routine nursing care. Both groups will be followed simultaneously and outcomes will be compared between them.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 30, 2026

Study Start

March 25, 2025

Primary Completion

December 11, 2025

Study Completion

March 22, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) collected during the study, including pain scores (VAS, NPRS), demographic data, and outcome measures, will be shared with other researchers upon reasonable request for academic and research purposes. All personal identifiers will be removed to ensure participant confidentiality.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be made available within 6 months after publication of the study results and will remain available for up to 5 years.
Access Criteria
Access to the data will be granted to qualified researchers upon reasonable request. Requests must include a research proposal and will be reviewed by the principal investigator. Data will be shared after approval and signing of a data-sharing agreement to ensure ethical use and confidentiality.

Locations