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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05286476
• Other study ID #: /012/002926
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: March 25, 2021

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 25, 2021
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation

Intervention

Combination Product:
• Whole 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

Other:
• pelvic 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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.