Combined Effects of Whole Body Vibration and Abdominal Binders on Outcome Measures of Constipation in Postnatal Women

NCT06877871 | Completed

• 1 other identifier: Iqra Ishtiaq
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Constipation is a prevalent issue among postnatal women, often resulting in significant discomfort and reduced quality of life. Traditional treatments like dietary adjustments and laxatives frequently provide only temporary relief and may lead to dependency. Whole-body vibration therapy and abdominal binders have emerged as promising non-invasive interventions for improving bowel function and relieving constipation.

Conditions

Constipation in Postnatal Women; Constipation

Keywords

Constipation, C-section, pelvic floor, hemorrhoids, postpartum

Outcome Measures

Primary Outcomes (3)

• Patient assessment of constipation symptoms (PAC-SYM) Questionnaire It

  It is frequently used in clinical trials of constipation. It is an important tool for assessing the severity of patient reported symptoms of constipation. The 12-item questionnaire is divided into three symptom sub scales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe').

  A total of 18 sessions were conducted over a period of 6 weeks,

• Patient assessment of constipation quality of life (PAC-QOL) Questionnaire

  The PAC-QOL questionnaire is sub categorized to 4 items on physical discomfort, 8 items on psycho social discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. Response choice is a Likert scale from 0 to 4.

  A total of 18 sessions were conducted over a period of 6 weeks,

• Modified constipation assessment scale (MCAS)

  It is used to assess bowel function. It consists of a 3-point summated rating scale (0 = no problem ; 1 = some problem ; 2 = severe problem ) resulting in a total score that ranges from 0 ( no constipation ) to 16 ( severe constipation ).

  A total of 18 sessions were conducted over a period of 6 weeks,

Study Arms (2)

Experimental group: Whole body vibration

EXPERIMENTAL

WBV was developed initially for fitness and physical rehabilitation and has been moving into other areas of healthcare such as pain management and neurological recovery and improving circulation. whole body vibration (WBV) therapy for the body eases the physical functions of muscular and circulatory. Additionally, mechanical aids (e.g. abdominal binders) have been explored as support for abdominal region and proper posture, which in turn secondarily aid gastrointestinal function

Other: WBV utilizes mechanical vibrations to excite muscle, nerves. Abdominal binders are to help patients who have suffered abdominal trauma to stabilize core muscles, reduce pain, and improve mobility

Experimental group: Abdominal binders

EXPERIMENTAL

Abdominal binders are designed primarily to help patients who have suffered abdominal trauma to stabilize core muscles, reduce pain, and improve mobility. Improved posture, better breathing and a reduction of strain on the lower back are also aided by creating gentle pressure on the abdomen. Abdominal binders are conventionally used for physical support but recent evidence supports their use in improving bowel function as increased abdominal muscle recruitment and intra-abdominal pressure, both integral to a healthy peristaltic push.

Other: WBV utilizes mechanical vibrations to excite muscle, nerves. Abdominal binders are to help patients who have suffered abdominal trauma to stabilize core muscles, reduce pain, and improve mobility

Interventions

WBV utilizes mechanical vibrations to excite muscle, nerves. Abdominal binders are to help patients who have suffered abdominal trauma to stabilize core muscles, reduce pain, and improve mobility OTHER

(WBV) is a therapeutic modality that utilizes mechanical vibrations to excite muscle, nerve and tissue structures in the body. WBV was developed initially for fitness and physical rehabilitation and has been moving into other areas of healthcare such as pain management and neurological recovery and improving circulation.However, this activation can help to elevate intestinal motility, reduce bloating and help overall digestion.

Also known as: Abdominal binders, Whole body vibrations

Experimental group: Abdominal binders; Experimental group: Whole body vibration

Eligibility Criteria

• Age: 22 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females age 22-35 years
• Females underwent C-section were included in the study
• Participants who had severe constipation
• Primary gravida
• Women who had 6 months of Postpartum period
• Single fetus pregnancy

You may not qualify if:

• Females who had normal delivery were excluded
• History of episiotomy
• Participants taking laxative were excluded
• History of post cesarean abdominal suture infections

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Constipation; Hemorrhoids

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adeela Arif, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: December 19, 2023
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)