Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy

Not Applicable

Completed

• Conditions: Post-Op Complication
• Interventions: Other: Advanced early Rehabilitation Program; Other: Early ambulation

• Registration Number: NCT04686032
• Lead Sponsor: Riphah International University

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

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2021-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advanced Rehab Group	Advanced early Rehabilitation Program	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
Early ambulation Group	Early ambulation	Participants of this group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy

Primary Outcome Measures

Name	Time	Method
Numeric pain rating scale (NPRS)	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	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.

Trial Locations

Locations (1)

Pakistan Railway hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan