Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT04686032

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Op Complication	Other: Advanced early Rehabilitation Program Other: Early ambulation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Both experimental and control groups will be treated at the same time following their respective protocolsBoth experimental and control groups will be treated at the same time following their respective protocols

Masking:

Single (Participant)

Masking Description:

This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
Numeric pain rating scale (NPRS) [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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pakistan Railway hospital	Rawalpindi	Punjab	Pakistan	44000

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Huma Riaz, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT04686032

Other Study ID Numbers:

REC/00834 Zarfasheen Zia

First Posted:

Dec 28, 2020

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Abdominal hysterectomy

postoperative pain

Early rehabilitation

Postoperative recovery profile

Additional relevant MeSH terms:

Postoperative Complications

Study Results

No Results Posted as of Sep 14, 2021