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Clinical Trials/NCT04686032
NCT04686032
Completed
Not Applicable

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

Riphah International University1 site in 1 country42 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Op Complication
Sponsor
Riphah International University
Enrollment
42
Locations
1
Primary Endpoint
Numeric pain rating scale (NPRS)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
July 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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