Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Post-Op Complication

Intervention / Treatment
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* Other: Advanced early Rehabilitation Program
* Other: Early ambulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Both experimental and control groups will be treated at the same time following their respective protocols
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced Rehab Group<br>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<br>* 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)<br>|
| Active Comparator: Early ambulation Group<br>Participants of this group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy | Other: Early ambulation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative recovery profile questionnaire | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal hysterectomy, postoperative pain, Early rehabilitation, Postoperative recovery profile