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

March 10, 2025 updated by: Riphah International University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Constipation is a complex condition arising due to many interrelated causes. Dietary inadequacies, most notably for fiber or fluid, often constitute a centerpiece of constipation. But other lifestyle factors including lack of movement and irregular bowel movements are also to blame. Known conditions affecting the gut motility, from medical perspective, include irritable bowel syndrome (IBS), diabetes, hypothyroidism, and neurological disorders including Parkinson's disease. Often listed as a side effect in medications such as opiates, antacids and antidepressants for example. Additionally, gut brain axis demonstrates that psychological aspects play a substantial part in the well being of the gut, since stress and anxiety frequently make matters worse. It is important to understand the causes of constipation to develop treatments.It is usually described as occurring less than three times per week, difficult to pass stools or passage of stools that does not feel satisfactory. Whereas, acute constipation can be often attributed to alteration in diet and water intake or stress, the chronic constipation is a long-standing pathological entity which can negatively affect the quality of life. Whole body vibration therapy (WBV) is a therapeutic modality that utilizes mechanical vibrations to excite muscle, nerve and tissue structures in the body. WBV is typically administered on a vibrating platform where the device is either controlled to deliver vibrations at specified frequencies and amplitudes as the individual performs a standing, sitting, or lying position. The vibrations produce rapid, involuntary muscle contractions- and result in a similar exercising effect without the impact to your body. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Riphah International University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group: Whole body vibration
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
(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.
Other Names:
  • Abdominal binders
  • Whole body vibrations
Experimental: Experimental group: Abdominal binders
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
(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.
Other Names:
  • Abdominal binders
  • Whole body vibrations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient assessment of constipation symptoms (PAC-SYM) Questionnaire It
Time Frame: A total of 18 sessions were conducted over a period of 6 weeks,
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
Time Frame: A total of 18 sessions were conducted over a period of 6 weeks,
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)
Time Frame: A total of 18 sessions were conducted over a period of 6 weeks,
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,

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adeela Arif, MS, Riphah International University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Iqra Ishtiaq

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

product manufactured in and exported from the U.S.

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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