| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
STAFF NURSES |
|
|
Intervention / Comparator Agent
|
|
|
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. |
|
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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. |