FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/01/048992 [Registered on: 13/01/2023] Trial Registered Prospectively
Last Modified On: 22/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Parents Led Respiratory Adjunctive Intervention]  
Study Design  Other 
Public Title of Study   parent learn the breathing exercises techniques and apply to their children with bronchial asthma for early overcome from the severity of the illness 
Scientific Title of Study   Effectiveness of Parent Led Respiratory Adjunctive Intervention on knowledge and skill of parents and respiratory parameters of children with bronchial asthma at selected settings 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAMAMURTHY MALA 
Designation  LECTURER IN PEDIATRIC NURSING 
Affiliation  College of Nursing Chengalpattu Government Medical College Chengalpattu  
Address  COLLEGE OF NURSING CHENGALPATTU GOVERNMENT MEDICAL COLLEGE CHENGALPATTU
The Tamilnadu Dr. M.G.R.Medical University No 69 Anna Salai, GUINDY, Chennai - 600032
Kancheepuram
TAMIL NADU
603001
India 
Phone  9940326434  
Fax  04426591617  
Email  malaramamoorthy8774@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  RAMAMURTHY MALA 
Designation  LECTURER IN PEDIATRIC NURSING 
Affiliation  College of Nursing Chengalpattu Government Medical College Chengalpattu  
Address  COLLEGE OF NURSING CHENGALPATTU GOVERNMENT MEDICAL COLLEGE CHENGALPATTU
The Tamilnadu Dr. M.G.R.Medical University No 69 Anna Salai, GUINDY, Chennai - 600032
Kancheepuram
TAMIL NADU
603001
India 
Phone  9940326434  
Fax  04426591617  
Email  malaramamoorthy8774@gmail.com  
 
Details of Contact Person
Public Query  
Name  KANCHANA S 
Designation  PRINCIPAL AND RESEARCH DIRECTOR  
Affiliation  OMAYAL ACHI COLLEGE OF NURSING, INTERNATIONAL CENTRE FOR COLLABORATIVE RESEARCH 
Address  OMAYAL ACHI COLLEGE OF NURSING, 45, AMBATHUR ROAD, PUZHAL, CHENNAI-600066 TAMILNADU INDIA
Affiliated to The,Tamilnadu Dr. M.G.R.Medical University No 69 Anna Salai, GUINDY, Chennai - 600032
Kancheepuram
TAMIL NADU
600066
India 
Phone  9884046488  
Fax  04426591617  
Email  kanchana_khan@yahoo.co.in  
 
Source of Monetary or Material Support  
Pediatric outpatient Department Chengalpattu Government Hospital, Government Primary Health Centre & Home set up in Chengalpattu District 
 
Primary Sponsor  
Name  RMALA Investigator OWN FUNDING  
Address  Faculty of Pediatric Department, College of Nursing Chengalpattu Medical College Chengalpattu-1 
Type of Sponsor  Other [NO EXTERNAL FUNDING SOURCE - Only Investigator her own fund is utilizing for this research study] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
R MALA   Chengalpattu Medical College, Chengalpattu-1  Pediatric Department, Division 1, Room Number 1, Government Primary Health Center and Home setup in Chengalpattu District, Tamilnadu state, India
Kancheepuram
TAMIL NADU 		 9940326434
04426591617
malaramamoorthy8774@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INTERNATIONAL CENTRE FOR COLLABORATIVE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Parent led respiratory adjunctive interventions  Parent led respiratory adjunctive interventions It is a set of intervention devised by the investigator and given administer to the parents (mother or father) who will in turn help the children practice the breathing techniques, so as to impact their respiratory outcome. These includes Information Education and Communication-Lecture and discussion regarding the general components of asthma will be explained by the investigator using video presentation and it will be given to the parent and their child which will take 20 to 30 minutes Buteyko Technique The Investigator will demonstrate the technique of Nasal breathing, relaxation relieve shortness of breath for 2 to 3 minutes which has to be done for 15 to 20 minutes of duration three times a day Pap worth technique The Investigator will demonstrate the technique of which includes control over breathing for 2 to 3 minutes and the same has to be repeated by the child under the guidance of the parent 3 times a day The sessions are led by parents Return Demonstration Parents will return demonstrate the Buteyko Technique and Papworth technique which will be on the child and this return demonstration will be assess by the investigator  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children aged 6 – 12 years, who have depressed with Bronchial Asthma within duration of 1 year

Parents of children who can able to understand and speak Tamil or English
Parents of children can able to understand and follow the instruction of breathing technique.
 
 
ExclusionCriteria 
Details  Children with other co-morbidities
Parents of children who have sensory impairments or mentally challenged 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Parent Led Respiratory Adjunctive (PRA)intervention on knowledge and skill of parents of Children with bronchial asthma

To assess the effectiveness of Parent Led Respiratory Adjunctive (PRA) on respiratory parameters of Children with bronchial asthma
 		 6 MONTHS
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/03/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Mala R., Asian Pacific Journal of Nursing. 2022, 9(2), 72-81. A Study to assess the effectiveness of video assisted teaching of prolonged use of diaper and its illness among mothers of infant in surgical department at Institute of child health and hospital for children, Egmore, Chennai-08. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study findings revealed that there is significant improvement in the knowledge of the mothers of infant followed by video assisted teaching. based on the statistical findings. its evident that the provision of video assisted teaching will motivate the mothers of infant to acquire knowledge and practice regarding management of diaper rashes and it’s illness that will ensure to maintain the normal life 
Close