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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
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