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

NCT05286476 | Completed

• 1 other identifier: /012/002926
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Constipation

Keywords

Whole Body Vibration; Postnatal women

Outcome Measures

Primary Outcomes (2)

• 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).

  Change from Baseline then after 6 weeks of intervention.

• 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.

  Change from Baseline then after 6 weeks of intervention.

Study Arms (2)

group A

EXPERIMENTAL

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

group B

OTHER

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

Whole Body Vibration COMBINATION_PRODUCT

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

group A

pelvic floor exercises and static abdominal exercises in addition to diet instructions OTHER

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.

group A; group B

Eligibility Criteria

• Age: 22 Years - 35 Years
• Gender Eligibility Details: females complains from postnatal constipation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 11432, Egypt

Location

Related Publications (1)

• Elfatah Elhosary EA, ElAzab DR, Hanoura EM, Othman EM. Effect Of Six Weeks Of Whole-Body Vibration In Treatment Of Postnatal Constipation. J Pak Med Assoc. 2023 Apr;73(Suppl 4)(4):S13-S16. doi: 10.47391/JPMA.EGY-S4-3.

  PMID: 37482821 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Doaa raafat, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 18, 2022
• Study Start: October 10, 2019
• Primary Completion: August 30, 2020
• Study Completion: March 25, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 1 year after publication
• Access Criteria: the criteria will be assessed by the publication of the trial in an international journals.

Locations

EG (1)