Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy
Primary Purpose
Post-Op Complication
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Advanced early Rehabilitation Program
Early ambulation
Sponsored by
About this trial
This is an interventional treatment trial for Post-Op Complication focused on measuring Abdominal hysterectomy, postoperative pain, Early rehabilitation, Postoperative recovery profile
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
Sites / Locations
- Pakistan Railway hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Advanced Rehab Group
Early ambulation Group
Arm Description
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
Participants of this group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04686032
First Posted
December 22, 2020
Last Updated
September 13, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04686032
Brief Title
Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy
Official Title
Effect of Early Physical Therapy Interventions on Post-operative Recovery and Complications Following Abdominal Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication
Keywords
Abdominal hysterectomy, postoperative pain, Early rehabilitation, Postoperative recovery profile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both experimental and control groups will be treated at the same time following their respective protocols
Masking
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.
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advanced Rehab Group
Arm Type
Experimental
Arm Description
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
Arm Title
Early ambulation Group
Arm Type
Active Comparator
Arm Description
Participants of this group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy
Intervention Type
Other
Intervention Name(s)
Advanced early Rehabilitation Program
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Early ambulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative recovery profile questionnaire
Description
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.
Time Frame
Post 3rd day
Title
Numeric pain rating scale (NPRS)
Description
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.
Time Frame
Baseline
Title
Numeric pain rating scale (NPRS)
Description
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.
Time Frame
Post 3rd day
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients after abdominal hysterectomies will be recruited.
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21830007
Citation
Citak Karakaya I, Yuksel I, Akbayrak T, Demirturk F, Karakaya MG, Ozyuncu O, Beksac S. Effects of physiotherapy on pain and functional activities after cesarean delivery. Arch Gynecol Obstet. 2012 Mar;285(3):621-7. doi: 10.1007/s00404-011-2037-0. Epub 2011 Aug 10.
Results Reference
background
PubMed Identifier
20846316
Citation
Allvin R, Svensson E, Rawal N, Ehnfors M, Kling AM, Idvall E. The Postoperative Recovery Profile (PRP) - a multidimensional questionnaire for evaluation of recovery profiles. J Eval Clin Pract. 2011 Apr;17(2):236-43. doi: 10.1111/j.1365-2753.2010.01428.x. Epub 2010 Sep 16.
Results Reference
background
PubMed Identifier
16137240
Citation
Mackay MR, Ellis E, Johnston C. Randomised clinical trial of physiotherapy after open abdominal surgery in high risk patients. Aust J Physiother. 2005;51(3):151-9. doi: 10.1016/s0004-9514(05)70021-0.
Results Reference
background
PubMed Identifier
22309427
Citation
Hanekom SD, Brooks D, Denehy L, Fagevik-Olsen M, Hardcastle TC, Manie S, Louw Q. Reaching consensus on the physiotherapeutic management of patients following upper abdominal surgery: a pragmatic approach to interpret equivocal evidence. BMC Med Inform Decis Mak. 2012 Feb 6;12:5. doi: 10.1186/1472-6947-12-5.
Results Reference
background
Citation
Reeve JC, Boden I. The physiotherapy management of patients undergoing abdominal surgery. New Zealand Journal of Physiotherapy. 2016;44(1).
Results Reference
background
PubMed Identifier
26804821
Citation
Castelino T, Fiore JF Jr, Niculiseanu P, Landry T, Augustin B, Feldman LS. The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review. Surgery. 2016 Apr;159(4):991-1003. doi: 10.1016/j.surg.2015.11.029. Epub 2016 Jan 21.
Results Reference
background
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Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy
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