ConstipationNCT05286476
Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
A study testing Whole Body Vibration and pelvic floor exercises and static abdominal exercises in addition to diet instructions in people with Constipation, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 22 to 35 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- Whole Body Vibration and pelvic floor exercises and static abdominal exercises in addition to diet instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2019to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Constipation
- Being tested
- Whole Body Vibration, pelvic floor exercises and static abdominal exercises in addition to diet instructions
- Keywords
- Whole Body Vibration, Postnatal women
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationCombination product
Also called pelvic floor exercises and static abdominal exercises in addition to diet instructions only
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
pelvic floor exercises and static abdominal exercises in addition to diet instructionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | received Whole-body Vibration, pelvic floor exercise and static abdominal exercises interventions In addition to diet instructions Receives: 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 Receives: Other: pelvic floor exercises and static abdominal exercises in addition to diet instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Change from Baseline then after 6 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start10 Oct 2019
- Primary completion30 Aug 2020
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed othman, Cairo University
- Investigators
- Doaa raafat, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286476
- Sponsor's protocol ID
- /012/002926
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Phuyal A; Burhan Ul Haq; Malik HN, John S, Ali K; Siraj Ul Haq. Endoscopic Endonasal Versus Endoscopic Supraorbital Keyhole Surgery for Craniopharyngioma Resection: A 15-Year Single-Center Retrospective Cohort Study. J Pak Med Assoc. 2026 Sep;76(Suppl 1)(9):S4. doi: 10.47391/JPMA-7ANOS-ABS-3.
PubMed 42817666Elfatah 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.
PubMed 37482821
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
- ClinicalTrials.gov ID
- NCT05286476
- Acronym / sponsor ID
- /012/002926
- Conditions
- Constipation
- Keywords
- Whole Body Vibration, Postnatal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Combination Product: Whole Body Vibration, Other: pelvic floor exercises and static abdominal exercises in addition to diet instructionsreceived Whole-body Vibration, pelvic floor exercise and static abdominal exercises interventions In addition to diet instructions |
| group B | Other | Other: pelvic floor exercises and static abdominal exercises in addition to diet instructionsreceived pelvic floor exercises and static abdominal exercises in addition to diet instructions only |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body VibrationAlso: pelvic floor exercises and static abdominal exercises in addition to diet instructions onlyvibration 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 | Combination product | group A |
| pelvic floor exercises and static abdominal exercises in addition to diet instructionsDuring 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. | Other | group A, group B |
Primary outcome
Patient Assessment of Constipation-Symptom questionnaire
Time frame: 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).
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 42817666Phuyal A; Burhan Ul Haq; Malik HN, John S, Ali K; Siraj Ul Haq. Endoscopic Endonasal Versus Endoscopic Supraorbital Keyhole Surgery for Craniopharyngioma Resection: A 15-Year Single-Center Retrospective Cohort Study. J Pak Med Assoc. 2026 Sep;76(Suppl 1)(9):S4. doi: 10.47391/JPMA-7ANOS-ABS-3.
- Derived from this study: PubMed 37482821Elfatah 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.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa raafat, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration and pelvic floor exercises and static abdominal exercises in addition to diet instructions in people with Constipation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment of Constipation-Symptom questionnaire (time frame: Change from Baseline then after 6 weeks of intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05286476, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.