| CTRI Number |
CTRI/2024/07/069971 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study- cross sectional study |
| Study Design |
Other |
|
Public Title of Study
|
This study will evaluate the Indian physiotherapists knowledge, opinion and practice towards early mobility in patients who have a chest tube |
|
Scientific Title of Study
|
Knowledge, Attitude and Practice of Indian Physiotherapists towards Early Mobilization of Patients with Intercostal Drain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Deshmukh |
| Designation |
MPT student |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Room no. 215 Department of Physiotherapy, Second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8097702471 |
| Fax |
|
| Email |
neha5.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Deshmukh |
| Designation |
MPT student |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Room no. 215 Department of Physiotherapy, Second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8097702471 |
| Fax |
|
| Email |
neha5.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Arun Maiya |
| Designation |
Dean and Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Room no. 215 Department of Physiotherapy, Second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845350823 |
| Fax |
|
| Email |
arun.maiya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room 215, Department of physiotherapy, 2nd floor, Manipal College of Health Professions
Manipal Academy of Higher Education Manipal 576104 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Room no. 215 Department of Physiotherapy, Second floor, Manipal
College of Health Professions, Manipal Academy of Higher
Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr G Arun Maiya |
Kasturba Hospital |
Room number 1 , N1 OPD
Department of Physiotherapy
First floor, Baliga Block,
Kasturba Hospital, Manipal,
Udupi.
Udupi
KARNATAKA |
9845350823
arun.maiya@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Physiotherapists practicing in India |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Physiotherapists- practicing in ICU setup with at least 1 year of experience |
|
| ExclusionCriteria |
| Details |
Physiotherapists not residing in India |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge, Attitude and Practice questionnaire |
One time- Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
18/07/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Developing a Knowledge, Attitude and Practice questionnaire by doing a thorough literature search will help define the constructs of knowledge, attitude and practice that the questionnaire will aim to measure. A set of items will be developed for each construct, and it will be ensured that the questions are clear, concise and unambiguous to avoid misinterpretation, of experts’ suggestions. Content validation of the questionnaire by 7-8 experts, with MPT in Cardiopulmonary Sciences, pursuing/completed PhD, will be done to identify any issues with clarity or comprehension. Suggestions will be incorporated and needed revisions will be made. After obtaining contact information, the questionnaire would be sent to the participants online via mail. Informed consent will be taken on the opening page of the survey and participant will be made aware that the confidentiality of their identity will be maintained and that they can withdraw from the study at any given point in time. Within a 2-week time interval, the link will be sent 3 times, after which the participants will be excluded if no response is recorded. The survey will be live until January 2025. Data obtained will be analyzed using the Jamovi 2.3.28 and the interpreted results will be presented comprehensively, focusing on the constructs of knowledge, attitude and practice individually. |