Respiratory StatusNCT03225274
Effectiveness of Breathing Exercises as Therapeutic Play on Respiratory Status Among Children With Lower Respiratory Tract Disorders
A study testing Breathing Exercises as Therapeutic Play in people with Respiratory Status, run by Maharishi Markendeswar University (Deemed to be University).
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Respiratory Status
- What is being tested?
- Breathing Exercises as Therapeutic Play
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- having upper respiratory tract infection
- on ventilator support.
- coming to hospital for OPD visits.
About this study
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."
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.
Read the 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.
- Conditions
- Respiratory Status
- Being tested
- Breathing Exercises as Therapeutic Play
- Keywords
- Breathing exercises, Respiratory status, Nebulization therapy, lower respiratory tract disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing Exercises as Therapeutic PlayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Other: Breathing Exercises as Therapeutic Play |
| Comparison Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startNov 2016
- Primary completionJan 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shally chaudhary, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Mr. Yogesh Kumar, M.Sc Nursing, Study director, Maharishi Markandeshwar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225274
- Sponsor's protocol ID
- 778
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 20399493Acharya 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.
PubMed 14723289
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT03225274
- Acronym / sponsor ID
- 778
- Conditions
- Respiratory Status
- Keywords
- Breathing exercises, Respiratory status, Nebulization therapy, lower respiratory tract disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Breathing Exercises as Therapeutic PlayExperimental 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 | No intervention | –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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- having upper respiratory tract infection
- on ventilator support.
- coming to hospital for OPD visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing Exercises as Therapeutic PlayOn 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. | Other | Experimental Group |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 20399493Nair 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.
- Background: PubMed 14723289Acharya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mr. Yogesh Kumar, M.Sc Nursing study director
Maharishi Markandeshwar University
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercises as Therapeutic Play in people with Respiratory Status, run by Maharishi Markendeswar University (Deemed to be University).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Clinical Respiratory Score (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03225274, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.