Effects of Breathing Exercises in the Mothers of Children With Special Health Care Needs
1 other identifier
interventional
46
1 country
1
Brief Summary
The aim of the study is to determine the effectiveness of breathing exercises combined with core stabilization exercises in mothers with chronic non-specific low back pain of children with special health care needs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2019
CompletedFirst Submitted
Initial submission to the registry
August 29, 2020
CompletedFirst Posted
Study publicly available on registry
September 14, 2020
CompletedSeptember 14, 2020
September 1, 2020
7 months
August 29, 2020
September 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change from Baseline in Low Back Pain at 8 weeks
Visual Analog Scale were used where patients were asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain at the baseline and the end of 8 weeks intervention.
Baseline, 8 weeks
Change from Baseline in Fatigue at 8 weeks
Fatigue Severity Scale was used where patients were asked to indicate their levels of agreement with a 0-7 scale indicating "0" strong disagreement and "7" strong agreement at a total of 9 questions. A sum of all responses was calculated for analysis. Sixty-three was the maximum score. The higher value represented a higher level of fatigue.
Baseline, 8 weeks
Change from Baseline in Anxiety at 8 weeks
Spielberger's State-Trait Anxiety Inventory was used to measure state and trait anxiety with 20 item self-report rating scale. The range of total scores was 20-80, and higher scores indicated higher levels of anxiety.
Baseline, 8 weeks
Change from Baseline in Sleep quality at 8 weeks
Pittsburg Sleep Quality Index was used to assess sleep quality consisting of a total of 24 questions, 19 of which were self-rated by the patient, and 5 of which were answered by the partner of the patient. The total scores ranged between 0 and 21 points with higher values representing worse sleep quality.
Baseline, 8 weeks
Study Arms (2)
Group 1:Breathing and Stabilization Exercise Group
EXPERIMENTALBreathing exercises combined with stabilization exercises
Group 2: Stabilization Exercise Group
ACTIVE COMPARATOROnly Stabilization exercises therapy
Interventions
Breathing exercises consist of the techniques of diaphragmatic and pursed-lip breathing. During the diaphragmatic breathing, attention is focused on the correct abdominal breathing. The pursed-lip breathing is one step further to the diaphragmatic breathing and a technique designed to have control time and volume over breathing.
Training about the concepts of stabilization and abdominal bracing is given before starting to the study. The motor control tests for local muscles transversus abdominus and multifidi are performed after the training. The abdominal bracing test is performed in the quadruped position, in prone, and in hook lying position with the patient's spine supine with hips and knees flexed and knees in contact with the surface. The second stage consists of closed-chain segmental control exercises. It is a series of weight-bearing exercises are performed on stable and unstable surfaces. The last stage of the stabilization program is an open kinetic chain exercise to promote distal stability.
Eligibility Criteria
You may qualify if:
- Primary caregiver of the child
- Suffering from LBP for at least three months
- Lumbar instability
- Absence of radiculopathy or other damages to the spine
- Not receiving any types of physical therapy during the trial or at least six months prior to the study
- Enough physical autonomy to participate in the physical activities
- Be volunteer
- Be compliant for the study
You may not qualify if:
- Taking any anti-depressant medications and/or having psychotherapy
- Any surgery within the last 3 months
- Be pregnant
- Presence of dysfunction of the musculoskeletal system during the study
- Participation rate lower than 80% of the program schedule
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hasan Kalyoncu University
Gaziantep, 27410, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 29, 2020
First Posted
September 14, 2020
Study Start
June 15, 2018
Primary Completion
December 31, 2018
Study Completion
February 20, 2019
Last Updated
September 14, 2020
Record last verified: 2020-09