Effects of Abdominal Binders and TENS on Puerperium Period After Cesarean Section

September 3, 2024 updated by: Riphah International University

Combined Effects of Abdominal Binders and TENS on Post-operative Pain, Distress and Constipation in Puerperium Period After Cesarean Section

To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 05499
        • PAF hospital and sheikh zayed hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants on early puerperium period having constipation and willing to participate.
  • Primigravida
  • Body mass index (BMI) less than 30 kg/m2

Exclusion Criteria:

  • Laxatives-induced patients
  • History of chronic constipation
  • Post cesarean abdominal suture infection.
  • People with chronic diseases, and who underwent non-routine or additional surgical procedures, such as hysterectomy, tubal ligation, and classical uterine incision.
  • Participants with inability to tolerate the binder.
  • Participants who show unwillingness to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TENS
Other: TENS
will receive TENS with high frequency (F=100Hz and T=100μs), intensity according to patient's pain threshold, duration of 30 continuous minutes, 2 cm above and below incision, with electrodes transversally positioned and crossing the incision. Two treatment sessions will be done per week for the period of 6 weeks. This group will be given tens along with abdominal binders with basic physiotherapy care. (23) In this treatment female's abdomen will be measured by a standard inch tape, then, according to the abdominal circumference, the binder will be fastened for 6 weeks. The binder will be placed tightly at the lower abdominal level with the incision positioned at the middle part of the binder. Participants will be asked to note the time to record the duration of binder wearing before taking the break. The binder will be opened between 10 pm and 8 am. This group will be given abdominal binders along with basic physiotherapy care
Experimental: ABDOMINAL BINDERS
Other: ABDOMINAL BINDERS
will be given abdominal binders along with basic physiotherapy care. Physiotherapy care will include sitting exercises such as deep breathing exercises, protected huffing technique will be performed to improve gases exchange and remove secretion. In supine exercises such as basic ROM, ankle pumps, pelvic rolling, leg sliding will be performed. Each exercise will be of 10 repetition. This exercise will be given for 2 days per week for 6 weeks. Along with these exercises education related postural management and breastfeeding positions will also be guided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
o Numeric Pain rating Scale
Time Frame: 6th week
Numeric pain rating scale is a subjective measure 11 point numerical scale which is used to measure pain. Is scoring range In this scale 0 shows no pain and 10 shows worst pain imaginable. It has good reliability of 0.79 and validity of 0.96.
6th week
o Symptom Distress scale
Time Frame: 6th week
Symptom distress scale is a 13 item self-assessment scale with 13 symptoms like pain, fatigue, insomnia, lack of appetite, nausea, breathlessness, lack of concentration, lack of appetite and altered mood. It's scoring is done by using 5 point Likert scale where 1 shows least distress and 5 shows extreme distress. With a total score ranging from 13 to 65. It has a reliability of 0.821 and validity of 0.825.
6th week
o PAC-SYM Questionnaire
Time Frame: 6th week
The PAC-SYM is a tool which is used to assess the severity of constipation. It range is from 0 and 48. Less value shows less severity of constipation. The patients were then asked to rate the severity of each symptom in a 5-point Likert scale (0-4; absent to very severe) during the past 2 weeks. The items were further categorized into 3 domains: abdominal symptoms (question 1-4), rectal symptoms (question 5-7), and stool symptoms (question 8-12). It is a reliable tool with value of 0.66 and validity with value of 0.75
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: hina gul gul, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2023

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 19, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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