Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy

September 13, 2021 updated by: Riphah International University

Effect of Early Physical Therapy Interventions on Post-operative Recovery and Complications Following Abdominal Hysterectomy

Variety of physical therapy treatments have been used after open abdominal surgery to improve cardiopulmonary and physical function as well as to reduce the incidence of postoperative pulmonary complications. This study intends to determine the effect of early physical therapy interventions on post-operative recovery profile, post-operative ileus and incisional pain following abdominal hysterectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is randomized controlled trial which will be conducted at in-patient gynecology department of Pakistan Railway hospital. This study would include total of 42 participants divided into two groups with 21 participants in each group calculated through OpenEpi (CI=95%Power=80%). Individuals will be screened according to inclusion and exclusion criteria and allocated randomly into two groups through sealed envelope method. Experimental group will receive early physical therapy interventions including patient education, ambulation, in-bed exercises, deep breathing exercises, connective tissue manipulation and TENS during the first 3 post-operative days following abdominal hysterectomy. While the control group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy.

Post-operative recovery will be assessed on 3rd post-operative day. Intensity of pain will be measured on baseline and 3rd post-operative day. The effect of intervention on post-operative ileus will be measured by monitoring each participant's time to tolerance of oral diet, first passage of stool and flatus

Study Type

Interventional

Enrollment (Actual)

42

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

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 44000
        • Pakistan Railway Hospital

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

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • open abdominal hysterectomy
  • Patient awake and responsive, stable blood pressure, stable heart rate, no dyspnea at rest and pain score < 8 on visual analogue scale on first post-operative day.
  • No limitation on physical activities due to any medical problem or restriction by the physician.

Exclusion Criteria:

  • Other hysterectomy procedures i.e. laparoscopic or vaginal hysterectomy.
  • Females with diabetes or cancer of metastatic nature.
  • Neurological or cognitive deficit.
  • Ongoing respiratory problem prior to initiation of physical therapy session.
  • Medical recommendation not to participate in early active rehabilitation

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: Advanced Rehab Group
The experimental group will receive early physical therapy interventions including patient education, ambulation, in-bed exercises, deep breathing exercises, connective tissue manipulation and TENS during the first 3 post-operative days following abdominal hysterectomy
Other: Advanced early Rehabilitation Program
Patient education, Ambulation, In bed exercises, Deep breathing exercises: (5 rep x 3set), Connective tissue manipulation for intestinal motility (5 min) and TENS* for incisional pain (30min)
Active Comparator: Early ambulation Group
Participants of this group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy
Other: Early ambulation
Patient education & Assisted ambulation out of bed including walking away from bedside for at least 15 min gradually moving to Unsupervised ambulation for 30 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative recovery profile questionnaire
Time Frame: Post 3rd day
For hospitalized patients a 17-item version of the PRP will be used (excluding the items "Re-establishing everyday life" and "Sexual activity"). The global score ranges from 0 to 17.
Post 3rd day
Numeric pain rating scale (NPRS)
Time Frame: Baseline
Numeric pain rating scale (NPRS) will be used for evaluating intensity of the incisional pain. Its scores range from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Baseline
Numeric pain rating scale (NPRS)
Time Frame: Post 3rd day
Numeric pain rating scale (NPRS) will be used for evaluating intensity of the incisional pain. Its scores range from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Post 3rd day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

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.

General Publications

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)

January 1, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00834 Zarfasheen Zia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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