| CTRI Number |
CTRI/2022/05/042548 [Registered on: 13/05/2022] Trial Registered Prospectively |
| Last Modified On: |
29/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Helfer Skin Tap technique on procedural pain among adult patients receiving IM Injection] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Assessment of effectiveness of Helfer Skin Tap technique on pain among adult patients receiving Intramuscular Injection. |
|
Scientific Title of Study
|
A Crossover Study to assess the effectiveness of Helfer Skin Tap technique on procedural pain among adult patients receiving Intramuscular Injection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwani Kumar Guray |
| Designation |
Student |
| Affiliation |
College of Nursing ,GMCH |
| Address |
Sarai building, sector 32.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9416021541 |
| Fax |
|
| Email |
ashwaniguray@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Devanshi |
| Designation |
Student |
| Affiliation |
College of Nursing ,GMCH |
| Address |
Sarai Building, Sector 32.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9464120464 |
| Fax |
|
| Email |
devanshichauhan14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dheeraj |
| Designation |
Student |
| Affiliation |
College of Nursing ,GMCH |
| Address |
Sarai Building, Sector 32.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
6283941937 |
| Fax |
|
| Email |
dheerajbisht643@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital , Sector 32 , Chandigarh |
|
|
Primary Sponsor
|
| Name |
Ashwani Kumar Guray |
| Address |
Sarai Building ,College of Nursing ,GMCH , Sector 32 , Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Rinku Mehmi |
Government Medical College and Hospital |
Orthopedics, Surgery and Medicine wards, GMCH Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9988899299
merimpy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics committee GMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Helfer Skin Tap technique |
1. The skin at the injection site is tapped several times with the palmer aspect of the fingers of the dominant hand for approximately five seconds to relax the muscle.
2. Then, a large V is made with the thumb and index finger of the non-dominant hand and skin is tapped with entire hand.
3. On the count of three, the needle is simultaneously inserted at a ninety-degree angle into the muscle.
4. After aspirating, medication is injected slowly, while continuing to gently tap the muscle with the palmer aspect of the fingers.
5. For removing the needle, simultaneous tapping of the skin is done with the non- dominant hand while the needle is withdrawn.
|
| Comparator Agent |
Intramuscular injection by Conventional technique |
involves inserting the needle after cleaning with alcohol swab intramuscularly without tapping.
The sequential method of intramuscular injection can be summarized as follows:
1. Explain the procedure to the patient to gain cooperation.
2. Check the 10 rights of medicine administration.
3. Calculate the prescribed dose to the administered.
4. Maintain privacy of the patient.
5. Wash hands properly.
6. Select the injection site.
7. Select appropriate needle and syringe size.
8. Assist patient into comfortable position.
9. Fill the injection and expel any air bubble from the syringe.
10. Hold syringe between thumb and forefinger of dominant hand with bevel of needle pointing up.
11. Change the needle.
12. Clean the site with antiseptic swab from center to outward in circular motion.
13. Hold the dry swab between the third and fourth fingers of the non-dominant hand.
14. Remove needle cover.
15. Hold the syringe correctly between the thumb and forefingers of dominant hand.
16. Pinch the skin.
17. Inject needle quickly at 90° angle.
18. Release the skin.
19. Grasp the lower end of syringe, do not move the syringe.
20. Pull back the plunger and aspirate. If no blood appears, slowly inject the medication.
21. Remove the non-dominant hand and quickly withdraw the leader apply pressure with antiseptics swab or do gentle massage.
22. Discard the uncapped needle and syringe.
23. Wash the articles and replace.
24. Monitor for localized redness, swelling, bleeding or inflammation at injection site.
25. Observe the patient at least 15 minutes following the injection for sign of reaction of the drug.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Adults (men and women above 18 years of age)
• Prescribed for at least two doses of Diclofenac 75mg/3ml intramuscular injection.
• Being cognitively able to rate pain scale and voluntarily signing the written informed consent.
• Being able to understand Hindi, Punjabi and English.
|
|
| ExclusionCriteria |
| Details |
Critically ill patients
Immediate post-operative patients
Unconscious patients
Sedated adult patient with sensory perceptual alteration
Thrombocytopenia
Coagulation defects
Known allergy or hypersensitivity of the drug
Myopathies
Associated muscular atrophy
Cancer patients
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of Helfer Skin Tap technique in reducing the pain level of the patient during intramuscular injection.
|
During procedure pain will be assessed by WONG BAKER FACES pain rating scale and after procedure pain will be assessed by numerical pain rating scale within 1 minute and 3 minutes of intervention.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between the level of pain experienced during intramuscular injection using conventional technique and Helfer Skin Tap technique among adult patients receiving intramuscular injection. |
During procedure pain will be assessed by WONG BAKER FACES pain rating scale and after procedure pain will be assessed by numerical pain rating scale within 1 minute and 3 minutes of intervention.
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2022 |
| 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="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intramuscular drug administration is a technique in which the drug is directly injected into deep muscle is considered one of safest and reliable method of drug administration. However the process of an intramuscular injection is painful and uncomfortable for the patients. To reduce the pain during the intramuscular injection, various techniques have been developed and widely used. One of such technique is Helfer Skin Tap technique which seeks to minimize the pain associated with intramuscular injection in patients. In Helfer Skin Tap technique the muscle is tapped in a rhythmic manner before and during the injection to relax the muscle and provide a painless injection experience as tapping in a rhythmic manner provides mechanical stimulation and distraction. A Crossover Design is planned to assess the effectiveness of Helfer Skin Tap technique on procedural pain among adult patients receiving intramuscular injection. The study subjects will be chosen as per eligibility criteria. Inferential and descriptive statistics will be used to analyze the data. |