| CTRI Number |
CTRI/2017/08/009501 [Registered on: 28/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
09/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study to Assess the Pain Perception during Administration of Intramuscular Injection of Benzathine Penicillin with cold needle in Rheumatic Heart Disease Patients. |
|
Scientific Title of Study
|
A Study to Assess the Effect of Temperature of Needle on Perception of Pain during Administration of Intramuscular Injection of Benzathine Penicillin to Patients Having Rheumatic Heart Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Thomas |
| Designation |
Nursing Officer |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
Cabin no.22, Computer Facility
All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
9911281526 |
| Fax |
|
| Email |
niths20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajnish Juneja |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Professor
Department of Cardiology
All India Institute of Medical Sciences
New Delhi
South West
DELHI
110049
India |
| Phone |
9899614420 |
| Fax |
|
| Email |
rjuneja2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Thomas |
| Designation |
Nursing Officer |
| Affiliation |
AIIMS New Delhi |
| Address |
Cabin no.22, Computer Facility
All India Institute of Medical Sciences, New Delhi
South West
DELHI
110049
India |
| Phone |
9911281526 |
| Fax |
|
| Email |
niths20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nisha Thomas |
| Address |
Cabin no 22,Computer Facility,
All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Other [Investigator Initiated] |
|
|
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 |
| Nisha Thomas |
All India Institute of Medical Sciences, New Delhi |
ROOM NO 21,Injection Room, Cardio-Neuro Out Patient Department, All India Institute Of Medical Sciences
New Delhi
DELHI |
9911281526
niths20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe for Post Graduate Research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Rheumatic Heart Disease Patients receiving Benzathine Penicillin Injection every 3 weekly, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Room temperature needle |
Room temperature needle was used in comparison to cold needle while administering intramuscular injection |
| Intervention |
Using cold needle(0-2 degree Celsius) |
Using cold needle(0-2 degree Celsius) to administer intramuscular benzathine penicillin injection |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients and parents giving informed consent.
2.Patients receiving benzathine penicillin intramuscular injection every 21 days and capable of giving adequate response.
3.Absence of any problem/ conditions resulting in pain. |
|
| ExclusionCriteria |
| Details |
1.Muscular dystrophies
2.Disoriented patients
3.Diabetic neuropathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| subjective pain perception when administering intramuscular penicillin injection using cold needle as compared to room temperature needle as assessed by numerical rating scale |
Immediately after administering injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in objective pain assessment(Blood Pressure and Pulse) when cold needle was used compared to room temperature |
Five minutes before and after administering intramuscular injection |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "95"
Final Enrollment numbers achieved (India)="95" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/05/2009 |
| Date of Study Completion (India) |
01/01/2010 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
British Cardiac Nursing Journal[EMID:fdb9c399e7b73e12] article submitted |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study: Rheumatic heart disease (RHD) patients are committed to lifelong secondary prophylaxis with Intramuscular Benzathine Penicillin. The study was conducted as a part of Master’s dissertation to evaluate the effect of cold needle to decrease the pain associated with this injection. Material and Methods: A randomized crossover single blinded study was conducted at a tertiary care facility of India among 100 patients who received two injections 21 days apart, with room temperature needle and cold needle (0-2 degree Celsius) in random order. Pain was evaluated using numerical rating scale and biophysiological measures. Analysis was done using STATA 9.1; Paired t test and Wilcoxon signed rank test were applied with level of significance set at p< 0.05. Results: There was a significant decrease in subjective pain score when cold needle was used as compared to room temperature needle. (3.37 ±1.75 vs 5.58 ±1.68, p ≤ 0.0001). Conclusion: Cold needle decreased pain perception of patients receiving intramuscular injection of Benzathine Penicillin. Pain reducing technique may be useful in improving compliance of patients receiving benzathine penicillin. Keywords: Rheumatic heart disease, Benzathine penicillin, Cold needle |