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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03225274
Other study ID # 778
Secondary ID
Status Completed
Phase N/A
First received July 17, 2017
Last updated July 20, 2017
Start date November 2016
Est. completion date June 2017

Study information

Verified date July 2017
Source Maharishi Markendeswar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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 Design


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Maharishi Markendeswar University

References & Publications (2)

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. — View 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, Simões 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 10 minutes