Skip to main content
Clinical Trials/NCT06303245
NCT06303245
Recruiting
Not Applicable

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

Riphah International University1 site in 1 country28 target enrollmentFebruary 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section; Complications, Wound, Dehiscence
Sponsor
Riphah International University
Enrollment
28
Locations
1
Primary Endpoint
o PAC-SYM Questionnaire
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 23, 2023
End Date
September 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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.

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.

Study Sites (1)

Loading locations...

Similar Trials