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

Not Applicable

Recruiting

• Conditions: Cesarean Section; Complications, Wound, Dehiscence
• Interventions: Other: TENS; Other: ABDOMINAL BINDERS

• Registration Number: NCT06303245
• Lead Sponsor: Riphah International University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-23
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS	TENS	-
ABDOMINAL BINDERS	ABDOMINAL BINDERS	-

Primary Outcome Measures

Name	Time	Method
o PAC-SYM Questionnaire	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	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	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.

Trial Locations

Locations (1)

PAF hospital and sheikh zayed hospital; 🇵🇰 Lahore, Punjab, Pakistan