| CTRI Number |
CTRI/2016/09/007266 [Registered on: 09/09/2016] Trial Registered Retrospectively |
| Last Modified On: |
08/09/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
usefulness of blunt pressure for pain reduction and improving satisfaction |
|
Scientific Title of Study
|
Effectiveness of Blunt Pressure Technique on Pain Response and Satisfaction among 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 |
Dinesh Kumar S |
| Designation |
Post Graduate Student |
| Affiliation |
Christian Medical College Vellore |
| Address |
M.Sc Nursing II year
College of Nursing
Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9994067829 |
| Fax |
|
| Email |
sonofsun.dineshkumar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jasmin Anand |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
College of Nursing
Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9486186752 |
| Fax |
|
| Email |
jasminanand123@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dinesh Kumar S |
| Designation |
Post Graduate Student |
| Affiliation |
Christian Medical College Vellore |
| Address |
M.Sc Nursing II year
College of Nursing
Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9994067829 |
| Fax |
|
| Email |
sonofsun.dineshkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Review Board, Christian Medical College,
Ida scudder Road,
Vellore 632 004 |
|
|
Primary Sponsor
|
| Name |
Institutional Review Board |
| Address |
Christian Medical College
Ida Scudder Road
Vellore 632004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dinesh Kumar S |
Christian Medical College |
24 hours Injection Room, Accident & Emergency Department,
christian medical college,
Ida Scudder Road,
Vellore 632004 Vellore TAMIL NADU |
9994067829
sonofsun.dineshkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, CMC, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients receiving intramuscular injection in the injection room, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blunt Pressure Technique |
A plastic oval disc with multiple blunt pins will be used.It will look like a round comb and it will be pressed over the skin before, during and after the injection procedure. A gentle pressure will be applied over the disc and injection will be given through the middle hole created in the disc. Pain score and satisfaction will be assessed immediately after the injection. |
| Comparator Agent |
Standard Technique |
Intramuscular injection using the standard technique will be given as per the CMC clinical nursing procedure manual.Pain score and satisfaction will be assessed immediately after the injection. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give their consent to participate in the study.
Patients who can read and write English/Tamil/Telugu/Hindi/Malayalam/ Bengali
|
|
| ExclusionCriteria |
| Details |
Patients with infectious skin diseases and other dermatological problem.
Patients with pain, injury & trauma.
Patients with known bleeding disorder
Patient who is cognitively impaired
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in pain response and satisfaction of patients receiving intramuscular injection using standard technique and Blunt Pressure technique. |
soon after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/06/2015 |
| 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="1" Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title: Effectiveness of blunt pressure technique in pain response and satisfaction among patients receiving intramuscular injection Background: Pain is an ageless universal phenomenon. It is considered to be the’ fifth vital sign’. There are about 16 million injections are given per year worldwide. Pain originating from IM injection should not be underestimated, because a painful injection might incite severe fear of injection, which may lead a patient to delay seeking medical help. Objective: The study is intended to determine the effectiveness of blunt pressure technique in pain response and satisfaction among patients receiving intramuscular injection. It will also reveal the association of pain and satisfaction with selected demographic and clinical variable and also the relationship between pain and satisfaction Methodology: Using a Quantitative approach, An experimental study with post test only design will be undertaken to perform the study. Study will be done for 6 weeks of period. Patients receiving intramuscular injection in the 24 hour injection room of emergency department will be the samples. Consecutive sampling technique will be used and the subjects will be randomly allocated to control and experimental group. Patients with infectious skin diseases, bleeding disorder, trauma and injury, cognitively impairment will be excluded from the study. Control group will receive injection using standard technique and experimental group will receive injection using blunt pressure technique. Numeral Rating scale and satisfaction questionnaire will be used to collect the data. Descriptive and inferential statistics will be done using SPSS. Key words: Bluntpressure, Pain, Intramuscular injection |