Back to resultsDiaphragmatic Breathing as an Adjunctive Therapy in the Management of Children With Bladder and Bowel Disorders
Primary Purpose
Bladder and Bowel Disorder, Pediatric
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Diaphragmatic Breathing
Standard Urotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Bladder and Bowel Disorder, Pediatric focused on measuring Diaphragmatic breathing (DB), Bladder and bowel disorders (BBD), Autonomic nervous system (ANS), Heart rate variability (HRV), Deep breathing, Randomized controlled trial (RCT)
Eligibility Criteria
Inclusion Criteria:
1. Children with bladder and bowel disorders (BBD) will be diagnosed by the attending pediatric urologists via a combination of thorough clinical history, physical examination, BBD Questionnaire, uroflowmetric evaluation, and voiding and stool diary.
Exclusion Criteria:
- Known anatomic or neurological lower urinary tract abnormalities such as posterior urethral valve, urethral obstruction or stricture, ectopic ureters, congenital abnormalities of the spinal cord, or any previous surgery of the lower urinary tract.
- Current use of medication or treatments which affects bladder or ANS function. These include anti-cholinergics, anti-psychotics, anti-depressants, and neuromodulators.
- Any conditions or disorders that would affect the cardiovascular system or the activity of the ANS.
- Serious pulmonary issues or diaphragmatic problems that would interfere with the practice of diaphragmatic breathing technique.
- Psychological/behavioral abnormalities severe enough to prevent the cooperation of the child with the study coordinator or the urologist.
- Inability to provide consent.
- Inability to speak and/or understand in English.
Sites / Locations
- BC Children's and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Urotherapy (SU)
Standard Urotherapy (SU) + Diaphragmatic Beathing (DB)
Arm Description
Standard Urotherapy (SU): A non-invasive therapy combining cognitive, behavioral and physical therapy. The study team will explain the problem to the children and their parents and educate them on the following: proper voiding mechanics, sitting, standing positions, how and when to void, techniques on relaxing pelvic floor muscles, and avoiding straining. An assessment of bowel habits will be done and their diet and drinking/voiding habits will be modified to maintain proper hydration with timed voiding. Voiding diaries will be provided for the assessment of the bladder and bowel habits.
Standard Urotherapy (SU) with the addition of Diaphragmatic Breathing (DB): A non-invasive breathing technique that is performed by a marked expansion of the abdomen (contracting diaphragm) rather than chest cavity during inspiration and tightening of the stomach muscles during expiration. Participants will lie on their back on a flat surface. Head is supported with a pillow and knees are bent forward supported by another pillow. Participants will place one hand on chest and the other on the abdomen, then start inhalation by moving their abdomen out against their hand, breathing in through their nose while keeping their chest and the other hand as still as possible. During expiration, the participants will tighten their abdominal muscles by forcing them inward and breathe out through pursed lips while keeping the hand on the chest as still as possible. Participants will be asked to perform this exercise for 10 minutes 3 times daily for 3 months.
Outcomes
Primary Outcome Measures
Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only).
Secondary Outcome Measures
Number of withdrawals during the treatment period.
Number of children adhering to the diaphragmatic breathing schedule that is given to them.
This will be measured by the information obtained from the mobile application used during the study period.
Treatment acceptability of the proposed intervention (diaphragmatic breathing).
This outcome will be reported based on the participants and their parents' response to the Treatment Acceptability Questionnaires.
Change in High Frequency (HF) variation of HRV from baseline to end of treatment period for both study groups.
This outcome will be measured using state-of-the-art machine for recording heart rate variability.
Change in Total Power from baseline to end of treatment period for both study groups.
This outcome will be calculated from the measurements obtained from state-of-the-art machine for recording heart rate variability.
Change in heart rate from baseline to end of treatment period for both study groups.
Change in Pre-ejection Period (PEP) from baseline to end of treatment period for both study groups.
This outcome will be measured using state-of-the-art machine for recording heart rate variability.
Change in BBD score from baseline to end of treatment period for both study groups.
This outcome will be reported based on participants' response to a validated 5-point Likert scale questionnaire for diagnosing BBD.
Change in Pediatric Incontinence Questionnaire (PinQ) scores from baseline to end of treatment period for both study groups.
Change in average urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.
Average urinary flow rate will be measured using top-notch equipment for measuring uroflowmetry parameters. Average urinary flow rate will be reported in mL/sec.
Change in peak urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.
Peak urinary flow rate will be measured using top-notch equipment for measuring uroflowmetry parameters. Peak urinary flow rate will be reported in mL/sec.
Change in post-void residual volume from baseline to end of treatment period for both study groups.
A hand-held ultrasound device will be used for the measurement of the post-void residual volume.
Full Information
NCT ID
NCT02597764
First Posted
August 27, 2015
Last Updated
February 19, 2017
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02597764
Brief Title
Diaphragmatic Breathing as an Adjunctive Therapy in the Management of Children With Bladder and Bowel Disorders
Official Title
Use of Diaphragmatic Breathing (DB) in the Management of Bladder and Bowel Disorders in Children: A Pilot Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Urination is a result of a complex neuro-muscular coordination which involves the action and arrangement of different parts of nervous systems as well as the muscular structure of the lower part of the urinary system. When there is an abnormal pattern in bladder and bowel habits without any known neuronal lesions, the condition is called bladder and bowel disorder (BBD). The symptoms can range from the feeling of rushing to the toilet, urinary accidents to urinating much less than expected during the day.
The standard treatment for most cases of BBD starts with Standard Urotherapy (SU) which is a beneficial basic and harmless form of treatment widely used for all children with BBD. SU involves explaining of the problem to the children and their parents by the doctors and educating them on proper voiding mechanisms, sitting, and standing positions as well as how and when to void.
The purpose of this study is to explore the possibility of testing the additive effectiveness of Diaphragmatic Breathing exercise (DB) as an alternative and harmless additional treatment to SU in children with BBD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder and Bowel Disorder, Pediatric
Keywords
Diaphragmatic breathing (DB), Bladder and bowel disorders (BBD), Autonomic nervous system (ANS), Heart rate variability (HRV), Deep breathing, Randomized controlled trial (RCT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Urotherapy (SU)
Arm Type
Active Comparator
Arm Description
Standard Urotherapy (SU): A non-invasive therapy combining cognitive, behavioral and physical therapy. The study team will explain the problem to the children and their parents and educate them on the following: proper voiding mechanics, sitting, standing positions, how and when to void, techniques on relaxing pelvic floor muscles, and avoiding straining. An assessment of bowel habits will be done and their diet and drinking/voiding habits will be modified to maintain proper hydration with timed voiding. Voiding diaries will be provided for the assessment of the bladder and bowel habits.
Arm Title
Standard Urotherapy (SU) + Diaphragmatic Beathing (DB)
Arm Type
Experimental
Arm Description
Standard Urotherapy (SU) with the addition of Diaphragmatic Breathing (DB):
A non-invasive breathing technique that is performed by a marked expansion of the abdomen (contracting diaphragm) rather than chest cavity during inspiration and tightening of the stomach muscles during expiration. Participants will lie on their back on a flat surface. Head is supported with a pillow and knees are bent forward supported by another pillow. Participants will place one hand on chest and the other on the abdomen, then start inhalation by moving their abdomen out against their hand, breathing in through their nose while keeping their chest and the other hand as still as possible. During expiration, the participants will tighten their abdominal muscles by forcing them inward and breathe out through pursed lips while keeping the hand on the chest as still as possible. Participants will be asked to perform this exercise for 10 minutes 3 times daily for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Diaphragmatic Breathing
Intervention Type
Behavioral
Intervention Name(s)
Standard Urotherapy
Primary Outcome Measure Information:
Title
Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of withdrawals during the treatment period.
Time Frame
3 months
Title
Number of children adhering to the diaphragmatic breathing schedule that is given to them.
Description
This will be measured by the information obtained from the mobile application used during the study period.
Time Frame
3 months
Title
Treatment acceptability of the proposed intervention (diaphragmatic breathing).
Description
This outcome will be reported based on the participants and their parents' response to the Treatment Acceptability Questionnaires.
Time Frame
3 months
Title
Change in High Frequency (HF) variation of HRV from baseline to end of treatment period for both study groups.
Description
This outcome will be measured using state-of-the-art machine for recording heart rate variability.
Time Frame
Baseline and 3 months
Title
Change in Total Power from baseline to end of treatment period for both study groups.
Description
This outcome will be calculated from the measurements obtained from state-of-the-art machine for recording heart rate variability.
Time Frame
Baseline and 3 months
Title
Change in heart rate from baseline to end of treatment period for both study groups.
Time Frame
Baseline and 3 months
Title
Change in Pre-ejection Period (PEP) from baseline to end of treatment period for both study groups.
Description
This outcome will be measured using state-of-the-art machine for recording heart rate variability.
Time Frame
Baseline and 3 months
Title
Change in BBD score from baseline to end of treatment period for both study groups.
Description
This outcome will be reported based on participants' response to a validated 5-point Likert scale questionnaire for diagnosing BBD.
Time Frame
Baseline and 3 months
Title
Change in Pediatric Incontinence Questionnaire (PinQ) scores from baseline to end of treatment period for both study groups.
Time Frame
Baseline and 3 months
Title
Change in average urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.
Description
Average urinary flow rate will be measured using top-notch equipment for measuring uroflowmetry parameters. Average urinary flow rate will be reported in mL/sec.
Time Frame
Baseline and 3 months
Title
Change in peak urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.
Description
Peak urinary flow rate will be measured using top-notch equipment for measuring uroflowmetry parameters. Peak urinary flow rate will be reported in mL/sec.
Time Frame
Baseline and 3 months
Title
Change in post-void residual volume from baseline to end of treatment period for both study groups.
Description
A hand-held ultrasound device will be used for the measurement of the post-void residual volume.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Children with bladder and bowel disorders (BBD) will be diagnosed by the attending pediatric urologists via a combination of thorough clinical history, physical examination, BBD Questionnaire, uroflowmetric evaluation, and voiding and stool diary.
Exclusion Criteria:
Known anatomic or neurological lower urinary tract abnormalities such as posterior urethral valve, urethral obstruction or stricture, ectopic ureters, congenital abnormalities of the spinal cord, or any previous surgery of the lower urinary tract.
Current use of medication or treatments which affects bladder or ANS function. These include anti-cholinergics, anti-psychotics, anti-depressants, and neuromodulators.
Any conditions or disorders that would affect the cardiovascular system or the activity of the ANS.
Serious pulmonary issues or diaphragmatic problems that would interfere with the practice of diaphragmatic breathing technique.
Psychological/behavioral abnormalities severe enough to prevent the cooperation of the child with the study coordinator or the urologist.
Inability to provide consent.
Inability to speak and/or understand in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kourosh Afshar, MD, MHSc, FAAP
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mir Sohail Fazeli, MD, PhD(c)
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Paul Collet, MD, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's and Women's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
12. IPD Sharing Statement
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Diaphragmatic Breathing as an Adjunctive Therapy in the Management of Children With Bladder and Bowel Disorders
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