| CTRI Number |
CTRI/2024/05/066855 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of assessment of quality of life and emotional wellbeing in paralysis patients |
|
Scientific Title of Study
|
Assessing the influence of emotional well-being on the overall quality of life on patients affected with paralysis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kuntal godde |
| Designation |
Post Graduate in clinical research |
| Affiliation |
|
| Address |
Dept. of Neurology, Acharya Vinoba Bhave Rural Hospital, DMIHER, Sawangi, Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7720062285 |
| Fax |
|
| Email |
kuntalgodde15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Gaurav Mude |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave Rural Hospital,DMIHER, Sawangi, Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8007095656 |
| Fax |
|
| Email |
gaurav.pharmacy@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kuntal godde |
| Designation |
Post Graduate in clinical research |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave Rural Hospital,DMIHER, Sawangi, Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7720062285 |
| Fax |
|
| Email |
kuntalgodde15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha 442001, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research Sawangi Wardha |
| Address |
Dept of Clinical Research Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha 442001, Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Kuntal Godde |
Acharya Vinoba Bhave Rural Hospital Sawangi(Meghe) Wardha |
Department of Neurology
Wardha
MAHARASHTRA |
7720062285
kuntalgodde15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Age 18-60 years
Duration of paralysis 1 year.
Willingness to Share Experiences
Access to Healthcare
Stable Medical Condition
|
|
| ExclusionCriteria |
| Details |
Children’s.
Other Severe Health Conditions (e.g., terminal illness).
Recent Trauma or Loss.
Cognitive Impairment.
Person who are not ready to give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Emotional well-being
Quality of life |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not any |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/06/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: The aim of this study is to investigate and understand the impact of emotional well-being on the overall quality of life for individuals affected by paralysis. Objective: · To capture a compressive range of emotional factors, including stress and anxiety. · To investigate the correlations between emotional well-being and different facets of quality of life. · To identify emotional factors that paly a significant role in shaping overall life satisfaction. · To encourage the development of integrated care approaches that comprehensively address the physical and emotional aspects of paralysis.
|