| CTRI Number |
CTRI/2025/02/080125 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
AN EXPERIMENTAL STUDY TO ASSESS THE EFFECTIVENESS OF DISTRACTION TECHNIQUE VS LOCAL COLD APPLICATION ON LEVEL OF PAIN,FEAR & BEHAVIOURAL DISTRESS DURING INTRAVENOUS PROCEDURE AMONG CHILDREN AT SELECTED HOSPITALS IN CHENNAI |
|
Scientific Title of Study
|
AN EXPERIMENTAL STUDY TO ASSESS THE EFFECTIVENESS OF DISTRACTION TECHNIQUE VS LOCAL COLD APPLICATION ON LEVEL OF PAIN,FEAR & BEHAVIOURAL DISTRESS DURING INTRAVENOUS PROCEDURE AMONG CHILDREN AT SELECTED HOSPITALS IN CHENNAI |
| Trial Acronym |
Distraction technique and local cold application |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Sengupta |
| Designation |
Lecturer |
| Affiliation |
Bhaarath college of Nursing |
| Address |
Jagadambha fancy store opposite to Bharath institute of higher education and research selaiyur chennai-600073 Bhaarath college of Nursing Bharath Institute of Higher Education & Research Kancheepuram TAMIL NADU 600073 India |
| Phone |
6361924528 |
| Fax |
|
| Email |
piyagupta697@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Priya Sengupta |
| Designation |
Lecturer |
| Affiliation |
Bhaarath college of Nursing |
| Address |
Jagadambha fancy store opposite to Bharath institute of higher education and research selaiyur chennai-600073 Bhaarath college of Nursing Bharath Institute of Higher Education & Research Kancheepuram TAMIL NADU 600073 India |
| Phone |
6361924528 |
| Fax |
|
| Email |
priya@bnch.in |
|
Details of Contact Person Public Query
|
| Name |
Priya Sengupta |
| Designation |
Lecturer |
| Affiliation |
Bhaarath college of Nursing |
| Address |
Jagadambha fancy store opposite to Bharath institute of higher education and research selaiyur chennai-600073 Bhaarath college of Nursing Bharath Institute of Higher Education & Research Kancheepuram TAMIL NADU 600073 India |
| Phone |
6361924528 |
| Fax |
|
| Email |
piyagupta697@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaarath Medical College And Hospital |
|
|
Primary Sponsor
|
| Name |
Priya Sengupta |
| Address |
Bhaarath College Of Nursing, Bharath Institute of Higher Education and Research, Selaiyur, Chennai-600073 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| BMCH management |
bharath medical college and hospital |
Selaiyur, Chennai 600073 Kancheepuram TAMIL NADU |
91 44-61116222
office@bmch.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| bharath institutional ethical committee |
Approved |
| bharath institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: U07-U07||Provisional assignment of new diseases of uncertain aetiology or emergency use (U00-U49), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.MALE AND FEMALE CHILD IN BETWEEN 3TO 6 YEARS AGE GROUPS ONLY INCLUDED INCLUSION CRITERIA, WHO ARE RECEIVING INTRAVENOUS THERAPY
2.WHO ARE WILLING TO PARTICIPATE IN THAT STUDY
3. WHO ARE ADMITTED IN PEDIATRIC EMERGENCY,MEDICINE OUT PATIENT DEPARTMENT, PEDIATRIC GENERAL WARD AND PEDIATRIC INTENSIVE CARE UNIT |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for sampling refers to children:
1. Children those who are critically ill.
2. Children those who are mentally challenged children.
3. Children with skin abrasions or any type of skin lesions at procedure site.
4. Children who are admitted with surgical condition.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparison between distraction technique vs local cold application on level ofpain, fear and behavioural distress children receiving intravenous therapy |
6-9months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to reduce the level of pain, fear & behavioural distress among children receiving intravenous procedure |
6-9 months |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| Date of Study Completion (India) |
12/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/06/2025 |
|
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
ONE SCOPUS JOURNAL OBSTETRICS AND GYNAECOLOGY FORUM AND ONE WEB OF SCIENCE LIBERTY JOURNAL PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A distraction strategy is an activity that takes the children’s mind off the current emotions. Instead of putting the energy into worries and increasing distress, this technique can focus on other things instead to give our mind and body time to calm down. Cold application relieves pain and prevents complications, by slowing down the ability of pain fibres to transmit pain impulses, decreasing edema and inflammation. Cold application prior to the procedure helps in reducing physical distress and making the child comfortable. Local cold applications provide transient anaesthesia to the skin within moments of application. Distraction are chosen as the primary intervention because it provides a simple approach in reducing pain and fear that has been shown to be effective in a number of settings since it is easy, economical. Observational assessment is an important component of a comprehensive evaluation of children’s procedural pain. |