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Effectiveness of Breathing Exercises as Therapeutic Play on Respiratory Status Among Children With Lower Respiratory Tract Disorders

Primary Purpose

Respiratory Status

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Breathing Exercises as Therapeutic Play
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Status focused on measuring Breathing exercises, Respiratory status, Nebulization therapy, lower respiratory tract disorders

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental Group

    Comparison Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Modified Clinical Respiratory Score
    To assess the Respiratory Status of children. The scoring of Modified Clinical Respiratory Score from 0 (Mild Respiratory status) to 12(Severe respiratory status)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 17, 2017
    Last Updated
    July 20, 2017
    Sponsor
    Maharishi Markendeswar University (Deemed to be University)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03225274
    Brief Title
    Effectiveness of Breathing Exercises as Therapeutic Play on Respiratory Status Among Children With Lower Respiratory Tract Disorders
    Official Title
    "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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maharishi Markendeswar University (Deemed to be 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
    The study evaluates the effectiveness of Breathing Exercises as Therapeutic Play on respiratory Status among children with Lower respiratory Tract Disorders. patient were allocated into two groups- Experimental group and Comparison group. Experimental Group received Breathing Exercises as Therapeutic Play after administration of Nebulization therapy and comparison Group received no Breathing Exercises.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Status
    Keywords
    Breathing exercises, Respiratory status, Nebulization therapy, lower respiratory tract disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Comparison Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Breathing Exercises as Therapeutic Play
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Modified Clinical Respiratory Score
    Description
    To assess the Respiratory Status of children. The scoring of Modified Clinical Respiratory Score from 0 (Mild Respiratory status) to 12(Severe respiratory status)
    Time Frame
    10 minutes

    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: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mr. Yogesh Kumar, M.Sc Nursing
    Organizational Affiliation
    Maharishi Markandeshwar University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20399493
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    14723289
    Citation
    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.
    Results Reference
    background

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    Effectiveness of Breathing Exercises as Therapeutic Play on Respiratory Status Among Children With Lower Respiratory Tract Disorders

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