Back to resultsEffect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
Primary Purpose
Constipation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Whole Body Vibration
pelvic floor exercises and static abdominal exercises in addition to diet instructions
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring Whole Body Vibration, Postnatal women
Eligibility Criteria
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.
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
group A
group B
Arm Description
received Whole-body Vibration, pelvic floor exercise and static abdominal exercises interventions In addition to diet instructions
received pelvic floor exercises and static abdominal exercises in addition to diet instructions only
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05286476
Brief Title
Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
Official Title
Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
March 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Whole Body Vibration, Postnatal women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
received Whole-body Vibration, pelvic floor exercise and static abdominal exercises interventions In addition to diet instructions
Arm Title
group B
Arm Type
Other
Arm Description
received pelvic floor exercises and static abdominal exercises in addition to diet instructions only
Intervention Type
Combination Product
Intervention Name(s)
Whole Body Vibration
Other Intervention Name(s)
pelvic floor exercises and static abdominal exercises in addition to diet instructions only
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
pelvic floor exercises and static abdominal exercises in addition to diet instructions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Assessment of Constipation-Symptom questionnaire
Description
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.
Title
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
Description
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.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
females complains from postnatal constipation
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa raafat, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
11432
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
1 year after publication
IPD Sharing Access Criteria
the criteria will be assessed by the publication of the trial in an international journals.
Learn more about this trial
Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
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