| CTRI Number |
CTRI/2018/12/016745 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
04/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [nursing intervention ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assess effectiveness of Helfer Skin Tap on pain associated with intramuscular injection Benzathine pencillin in Rheumatic Heart disease patient |
|
Scientific Title of Study
|
A study to assess the effectiveness of Helfer skin tap technique on pain associated with intramuscular (IM)Benzathine Pencillin injection among Rheumatic Heart Disease patients attending CardiologyOPD in selected Hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shanti jakhwal |
| Designation |
MSc NSg student |
| Affiliation |
AFMC |
| Address |
college of nursing , AFMC ,Pune
medical surgical Nursing ,
College of Nursing ,AFMC ,wanowrie ,pune
Pune
MAHARASHTRA
410040
India |
| Phone |
9910209379 |
| Fax |
|
| Email |
shantijakhwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col Priya Nair |
| Designation |
MSc NSg student |
| Affiliation |
AFMC |
| Address |
college of nursing , AFMC ,Pune
Pune
MAHARASHTRA
410040
India |
| Phone |
9465961032 |
| Fax |
|
| Email |
nairpriya79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shanti jakhwal |
| Designation |
MSc NSg student |
| Affiliation |
AFMC |
| Address |
college of nursing , AFMC ,Pune
medical Surgical nursing
F 502 , Ganga Savera society
Pune
MAHARASHTRA
410040
India |
| Phone |
9910209379 |
| Fax |
|
| Email |
shantijakhwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shanti Jakhwal ,college of Nursing AFMC
medical Surgical Nursing Pune |
|
|
Primary Sponsor
|
| Name |
Maj Shanti Jakhwal |
| Address |
college of Nursing AFMC ,wanowrie , Pune 410041 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| govt aid |
IHQ MOD |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SHANTI JAKHWAL |
Command Hospital pune |
cardiology OPD , Injection room , Command Hospital WANOWIRE PUNE
Pune
MAHARASHTRA |
9910209379
-
shantijakhwal@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Afmc |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I050||Rheumatic mitral stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
helfer skin tap |
in this technique the ventrogluteal site of experiment group will be tapped 16 times within 5 sec before intramuscular inj benzathine pencillin before injection |
| Comparator Agent |
manual pressure |
in this the control group will be given normal manual pressure after intramuscular injection bemzathine pencillin |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Rheumatic heart disease patient on injection Benzathine Penicillin |
|
| ExclusionCriteria |
| Details |
patients other than RHD who receive inj Benzathine
localised skin infection on ventrogluteal site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is difference in pain score of patient with Helfer skin Tap than without Tap |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is association between pain intensity and selected demographic variables like Age , sex , duration of treatment |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
28/12/2018 |
| 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="0"
Months="2"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study to assess the effectiveness of Helfer Skin tap technique on pain associated with inj Benzathine penicillin among rheumatic Heart disease patient The investigator used experimental - post test only control design to randomly selecting 50 patients and adopting Helfer skin for experiment group and conventional technique for control group . |