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CompletedNCT05286476Updated Mar 18, 2022

Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation

An interventional study of Whole Body Vibration and pelvic floor exercises and static abdominal exercises in addition to diet instructions in Constipation, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 22 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Oct 2019, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
22 Years to 35 Years
Sex
Female
01

Study summary

Background: Postpartum constipation is a common problem affecting postpartum mothers. Aim: To determine whether Whole Body Vibration is effective in treatment of postnatal women constipation. Design: The study was designed as a prospective, randomized, single-blind, pre-post-test, controlled trial.

HYPOTHESES:

It will be hypothesized that:

It was hypothesized that whole-body vibration has no or limited effect in treatment of postnatal constipation RESEARCH QUESTION: Does whole-body vibration has an effect in treatment of postnatal constipation?

Read the detailed description

Methods: Group A received whole-body vibration, pelvic floor exercise and static abdominal exercises interventions for six weeks and group B received pelvic floor exercises and static abdominal exercises in addition to diet instructions in both groups. Constipation symptom questionnaire and patient assessment of constipation quality of life questionnaire is applied before and after treatment.

02

Conditions studied

  • Constipation

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Keywords

  • Whole Body Vibration
  • Postnatal women
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • The participants age ranged from 22 to 35 years old
  • with vaginal delivery
  • complain from postnatal constipation from (2 - 6 weeks) post-delivery
  • had body mass index (BMI) ranged from 30 to 32 kg/m2.

Exclusion criteria

Exclusion Criteria:

Participants were excluded if they:

  • had diabetes, hypertension, cardiac diseases.
  • Women who had history of inflammatory bowel disease and abnormalities of anal region or anal fissure
  • women who had history of bowel surgery (other than appendectomy),
  • patients who had endocrine disease or digestive tract disease
  • history of neurological or musculoskeletal disorder.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    group A

    received Whole-body Vibration, pelvic floor exercise and static abdominal exercises interventions In addition to diet instructions

    Combination Product: Whole Body Vibration · Other: pelvic floor exercises and static abdominal exercises in addition to diet instructions

  • Other
    group B

    received pelvic floor exercises and static abdominal exercises in addition to diet instructions only

    Other: pelvic floor exercises and static abdominal exercises in addition to diet instructions

Interventions

  • Combination productWhole Body Vibration

    vibration was administered for 1min, with a rest interval of 1min between each vibration set repeating 10 vibrations, with a frequency of 30 Hz and an amplitude of 0-2 mm and a speed of 50 m /s,18 and these sessions lasted for 6 weeks 3 days a week. whole-body vibration was induced by a noninvasive oscillation platform

    Also known as: pelvic floor exercises and static abdominal exercises in addition to diet instructions only

  • Otherpelvic floor exercises and static abdominal exercises in addition to diet instructions

    During the low abdominal hollowing with instructed pelvic floor co-contraction test subjects were instructed with the standard command: 'Breathing normally, and keeping your back still, gently lift and tighten your pelvic floor. Now gently draw in your low tummy as well and hold it'. Pelvic floor facilitates transversus abdominis thickness. subject in supine lying with her arms crossed over the diastasis for support. And subject has to draw or pull the abdomen inwards so that there elicits an isometric contraction of abdominal muscles and repeated this for 5-7 times.

06

What researchers measure

Primary outcomes

  1. Patient Assessment of Constipation-Symptom questionnaire

    PAC-SYM is composed of three domains: abdominal symptoms, 4 items; rectal symptoms, 3 items; and stool symptoms, 5 items. Wording was as follows: ''How severe have each of these symptoms been in the last two weeks?'' Items are rated on a 5-point (0-4) Likert scale. Responses are scored as 0 = absence of symptom, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe. The ABD, REC and STO domain scores are the mean scores of each domain. Constipation was defined by the responses to the following questions: ''Have laxatives been taken during this period?'' (if ''yes'' then CC = 0: end of scoring); ''Have stools been passed on 3 or more days/week on average?'' (if ''yes'' then F = 0; if ''no'' then F = 1: in either case, and for subsequent questions, scoring is continued); ''Was stool passage difficult or painful?'' and ''Was stool consistency predominantly hard?'' The CC score indicates either constipation (CC = 2 or 3) or non-constipation (CC = 0 or 1).

    Time frame: Change from Baseline then after 6 weeks of intervention.

  2. Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)

    PAC-QOL questionnaire comprises 28 questions and depending on the factor analysis structure, the tool comprises four subscales, including "Physical discomfort (question 1-4)," "Psychosocial discomfort (question 5-12)," "Worries and concerns (question 13-23)," and "Satisfaction (question 24-28)." Similar to the Likert scale, each option is scored on a scale of 0-4 (least to the greatest effect), and higher scores indicate a worst quality of life. However, reverse coding was required in questions 18, 25, 26, 27, and 28 because they were positive questions, whereas the other 23 questions were negative ones.

    Time frame: Change from Baseline then after 6 weeks of intervention.

07

Study locations

1 site
  • Faculty of Physical Therapy
    Giza, 11432, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication

Supporting information: Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05286476
Lead sponsor
Cairo University
Responsible party
Eman Mohamed othman (professor, Cairo University) — Principal investigator
First posted
Mar 18, 2022
Start date
Oct 10, 2019
Primary completion
Aug 30, 2020
Completion
Mar 25, 2021
Last update
Mar 18, 2022

Study contacts

Doaa raafat, PhD
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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