- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03225274
Effectiveness of Breathing Exercises as Therapeutic Play on Respiratory Status Among Children With Lower Respiratory Tract Disorders
"A Study to Evaluate the Effectiveness of Breathing Exercises as Therapeutic Play on Respiratory Status Among Children Undergoing Nebulization Therapy With Lower Respiratory Tract Disorders in Selected Hospitals of Haryana."
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The subjects were selected by Purposive sampling technique and allocated into 2 groups i.e experimental and comparison group. the total sample size for the study was 60 children i.e 30 in Experiment Group and 30 in Comparison group.
Experimental Group- Pre-assessment of respiratory status among children was assessed. Then after 5 minutes of administration of Nebulization, breathing exercises as therapeutic play (balloon inflation, candle blowing, blow air into water with a straw was administered for 15 minutes once in a day for 3 days consecutively and then post-assessment was taken daily 5 minutes after the administration of breathing exercises as therapeutic play.
Comparison Group- Pre-assessment of respiratory status among children was assessed. Then only nebulization therapy was administered and then post-assessment was taken daily after 25 minutes of administered.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 5-18 years of age
- prescribed with Nebulization therapy
- able to understand hindi.
- available during the period of data collection and willing to participate in study.
Exclusion Criteria:
- having upper respiratory tract infection
- on ventilator support.
- coming to hospital for OPD visits.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Group
Experimental Group consist of 30 subjects.
Pre-assessment of respiratory status among children was assessed.
Then after 5 minutes of administration of Nebulization, breathing exercises as therapeutic play (balloon inflation, candle blowing, blow air into water with a straw was administered for 15 minutes once in a day for 3 days consecutively and then post-assessment was taken daily 5 minutes after the administration of breathing exercises as therapeutic play.
|
On day 1, pre- intervention assessment of respiratory status was done before administration of breathing exercises as therapeutic play and after 5 minutes of administration of Nebulization therapy, breathing exercises was administered among children for 15 minutes once in a day and then after 5 minutes 1st post-intervention assessment was done on same day. On 2nd day again after 5 minutes of administration of Nebulization therapy, breathing exercises was administered among children for 15 minutes once in a day and after 5 minutes again post-intervention assessment was done on same day. On 3rd day again after 5 minutes of administration of Nebulization therapy, breathing exercises was administered among children for 15 minutes once in a day and after 5 minutes again post-intervention assessment was done on same day. |
NO_INTERVENTION: Comparison Group
Comparison Group consist of 30 subjects.
Pre-assessment of respiratory status among children was assessed.
Then only nebulization therapy was administered and then post-assessment was taken daily after 25 minutes of administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Clinical Respiratory Score
Time Frame: 10 minutes
|
To assess the Respiratory Status of children.
The scoring of Modified Clinical Respiratory Score from 0 (Mild Respiratory status) to 12(Severe respiratory status)
|
10 minutes
|
Collaborators and Investigators
Investigators
- Study Director: Mr. Yogesh Kumar, M.Sc Nursing, Maharishi Markandeshwar University
Publications and helpful links
General Publications
- Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
- Acharya D, Prasanna KS, Nair S, Rao RS. Acute respiratory infections in children: a community based longitudinal study in south India. Indian J Public Health. 2003 Jan-Mar;47(1):7-13.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 778
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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