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CTRI Number  CTRI/2016/08/007147 [Registered on: 04/08/2016] Trial Registered Retrospectively
Last Modified On: 02/08/2016
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study    
Study Design  Other 
Public Title of Study   Pain management pratices performed by hospital nurses 
Scientific Title of Study   A study on pain assessment skills and management practices among staff nurses in our hospital  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gincy Peter 
Designation  Student 
Affiliation  FATHER MULLER COLLEGE OF NURSING 
Address  POOCHAKKATTIL HOUSE BRAHMAMANGALAM POST THALAYOLAPARAMBU VIA KOTTAYAM DISTRICT KERALA STATE
FATHER MULLER COLLEGE OF NURSING, KANKANADY, MANGALORE DAKSHINA KANNADA, KARNATAKA 575002
Kottayam
KERALA
686614
India 
Phone  09745546679  
Fax  08242438906  
Email  gincypeter1990@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs SHWETHA RASHMI MS 
Designation  ASSISTANT PROFESSOR 
Affiliation  FATHER MULLER COLLEGE OF NURSING 
Address  SUNDARKAMAL NIVAS 4th CROSS ROAD,ATTAVAR, MANGALORE DAKSHINA KANNADA KARNATAKA
FATHER MULLER COLLEGE OF NURSING KANKANADY, MANGALORE DAKSHINA KANNADA KARNATAKA 575002
Dakshina Kannada
KARNATAKA
575001
India 
Phone  09740510036  
Fax  08242438906  
Email  shwetharashmi@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Mrs SHWETHA RASHMI MS 
Designation  ASSISTANT PROFESSOR 
Affiliation  FATHER MULLER COLLEGE OF NURSING 
Address  SUNDARKAMAL NIVAS 4th CROSS ROAD,ATTAVAR, MANGALORE DAKSHINA KANNADA KARNATAKA
FATHER MULLER COLLEGE OF NURSING KANKANADY, MANGALORE DAKSHINA KANNADA KARNATAKA 575002
Dakshina Kannada
KARNATAKA
575001
India 
Phone  09740510036  
Fax  08242438906  
Email  shwetharashmi@yahoo.com  
 
Source of Monetary or Material Support  
Father Muller Medical College Hospital, Kankanady, Mangalore 
 
Primary Sponsor  
Name  Ms Gincy Peter 
Address  POOCHAKKATTIL HOUSE BRAHMAMANGALAM POST THALAYOLAPARAMBU VIA KOTTAYAM DISTRICT KERALA STATE 
Type of Sponsor  Other [Self Funded] 
 
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 
Gincy Peter  Father Muller Medical College Hospital  Father Muller Medical college hospital, Kankanady, Mangalore Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 
09745546679
08242438906
gincypeter1990@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  STAFF NURSES 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Staff nurses working in surgical and orthopedic wards, Father Muller Medical College Hospital, Mangalore.
2.Patient’s records from surgical and orthopedic wards whose pain management is documented.
 
 
ExclusionCriteria 
Details  1.Staff nurses who are in-charge of the ward and the postgraduates. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
FINDINGS OF THE STUDY SHOWN THAT MAJORITY OF SUBJECTS WERE POOR IN PAIN MANAGEMENT PRACTICES AS ASSESSED BY THE SELF REPORTED RATING SCALE.
THE PAIN MANAGEMENT DOCUMENTATION WAS ALSO POOR WHICH WAS ASSESSED USING PAIN MANAGEMENT PRACTICE DOCUMENTATION CHECKLIST.  
1 point time 
 
Secondary Outcome  
Outcome  TimePoints 
THERE WAS A WEAK POSITIVE CORRELATION BETWEEN THE SELF REPORTED PAIN MANAGEMENT PRACTICES WITH THE DOCUMENTATION  1 point time 
THERE WAS NO SIGNIFICANT ASSOCIATION BETWEEN THE DOCUMENTATION OF PAIN MANAGEMENT PRACTICES WITH THE SELECTED DEMOGRAPHIC VARIABLES  1 point time 
 
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)   01/06/2013 
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="1"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

     Objectives of the Study

1.         To determine patient’s pain management practices by staff nurses using a self-reported rating scale on pain management practices.

2.         To determine the level of practice in terms of documentation of pain management practices by the staff nurses using documentation checklist on pain management practices.

3.         To correlate the self reported pain management practices with the documentation.

4.         To find the association of the documentation of pain management practices with the selected demographic variables.

Hypotheses

H1: There will be a significant relationship between the pain management practices  and documentation by the staff nurses.

H2: There will be a significant association between the pain management practices with the selected demographic variables.

Method of Data Collection

1.         The information on pain management practices were collected using a self reported rating scale by the staff nurses .

2.         The documentation on pain management practices were evaluated by the investigator using a documentation checklist.

Results

The data showed that:

·         Majority (97.5%) of the subject’s reported poor pain management practices were as 2.5% reported good pain management practices.

·         100% of subjects practice in terms of documentation were poor.

·         There was a weak positive correlation (r= +0.124) between the level of self reported pain management practices with the documentation.

·         There was no significant association between the documentation of pain management practices with the selected demographic variables. 

 
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