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

Not Applicable

Completed

• Conditions: Constipation
• Interventions: Combination Product: Whole Body Vibration; Other: pelvic floor exercises and static abdominal exercises in addition to diet instructions

• Registration Number: NCT05286476
• Lead Sponsor: Cairo University

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?

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.

Study Timeline

• Study Start: 2019-10-10
• Primary Completion: 2020-08-30
• Study Completion: 2021-03-25
• Study First Submitted: 2022-02-28
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-09
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Whole Body Vibration	received Whole-body Vibration, pelvic floor exercise and static abdominal exercises interventions In addition to diet instructions
group A	pelvic floor exercises and static abdominal exercises in addition to diet instructions	received Whole-body Vibration, pelvic floor exercise and static abdominal exercises interventions In addition to diet instructions
group B	pelvic floor exercises and static abdominal exercises in addition to diet instructions	received pelvic floor exercises and static abdominal exercises in addition to diet instructions only

Primary Outcome Measures

Name	Time	Method
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)	Change from Baseline then after 6 weeks of intervention.	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.
Patient Assessment of Constipation-Symptom questionnaire	Change from Baseline then after 6 weeks of intervention.	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).

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Egypt