| CTRI Number |
CTRI/2021/09/036849 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ANALYSIS OF PAIN AND QUALITY OF LIFE IN PATIENTS WITH FRACTURE |
|
Scientific Title of Study
|
ASSESSMENT OF PAIN AND QUALITY OF LIFE IN PATIENTS WITH FRACTURE IN ORTHOPAEDIC DEPARTMENT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms FATHIMATHU ZZAKIYYA |
| Designation |
M Pharm |
| Affiliation |
NGSM Institute of Pharmaceutical sciences Nitte (deemed to be university) |
| Address |
Department Of Pharmacy Practice
Paneer, Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9846860818 |
| Fax |
|
| Email |
zehrinzaak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr BHARATH RAJ K C |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical sciences Nitte(deemed to be university) |
| Address |
Department Of Pharmacy Practice
Paneer, Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9035948490 |
| Fax |
|
| Email |
bharathraj@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr P NIRMAL BABU |
| Designation |
Assistant Professor |
| Affiliation |
JUSTICE K.S HEGDE CHARITABLE HOSPITAL, DERLAKATTE, MANGALURU |
| Address |
Department Of Orthopaedic
Justice KS Hegde Charitable Hospital, Derlakatte Mangalore.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09901725830 |
| Fax |
|
| Email |
drnirmalbabu@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| K S Hegde Charitable Hospital,Derlakatte,Mangalore |
|
|
Primary Sponsor
|
| Name |
Fathimathu Zzakiyya |
| Address |
Department of Pharmacy Practice, NGSM Institute Of Pharmaceutical Sciences, Paneer,Derlakatte, Manglore. |
| 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 |
| FATHIMATHU ZZAKIYYA |
Justice K. S. Hegde Charitable Hospital |
Department Of Orthopaedics
Dakshina Kannada
KARNATAKA |
9846860818
zehrinzaak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M908||Osteopathy in diseases classifiedelsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients aged 18 years and above, diagnosed with fracture, admitted to the Orthopaedics department
|
|
| ExclusionCriteria |
| Details |
1.Critically ill patients
2.Patients who are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study is expected to highlight the importance of proper assessment of pain as well as the quality of life of patients with fractures. |
Single point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PAIN IS CALCULATED USING PAIN NUMERIC SCALE |
Single point |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
27/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/09/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a prospective
study of assessment of pain and quality of life in patients with fracture in
orthopaedic department. The pain will be assessed by using pain numeric scale.
In this study I will be enrolling 55 patients who has admitted to the orthopaedic
dept, diagnosed with fracture. The patients aged 18 years and above, diagnosed
with fracture. |