| CTRI Number |
CTRI/2024/09/073374 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Tracheostomy home care ] |
| Study Design |
Other |
|
Public Title of Study
|
Study to assess the effectiveness of standardized hands-on-training regarding Tracheostomy Care on Knowledge and Skills of Caregivers of Tracheostomized Patients |
|
Scientific Title of Study
|
A Quasi-experimental study to assess the effectiveness of standardized hands-on-training regarding Tracheostomy Care on Knowledge and Skills of Caregivers of Tracheostomized Patients at a tertiary care hospital, Uttarakhand |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Choudhary |
| Designation |
Student |
| Affiliation |
AIIMS Rishikesh |
| Address |
college of nursing, AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8440088697 |
| Fax |
|
| Email |
deepika10012001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ruchika Rani |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
level-3, college of nursing, AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9814143556 |
| Fax |
|
| Email |
ruchika.nur@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Choudhary |
| Designation |
Student |
| Affiliation |
AIIMS Rishikesh |
| Address |
college of nursing, AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8440088697 |
| Fax |
|
| Email |
deepika10012001@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of medical sciences Rishikesh
Virbhadra Road, Rishikesh
Uttarakhand-249203, India |
|
|
Primary Sponsor
|
| Name |
Deepika Choudhary |
| Address |
college of nursing, AIIMS Rishikesh
Virbhadra Road, Rishikesh 249203, India
|
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ruchika Rani |
Level-, college of nursing, AIIMS Rishikesh. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchika Rani |
AIIMS Rishikesh Hospital |
Pulmonary Medicine ward, Neurology ward,
Neurosurgery Ward,
ENT ward
Dehradun
UTTARANCHAL |
9814143556
ruchika.nur@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All india institute of medical sciences, Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of Tracheostomized patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard care |
Routine care and health education given in the wards by the health care professionals |
| Intervention |
Standardized Hands-on-training regarding tracheostomy care |
This intervention is for the caregivers of tracheostomized patients who will take care of them at home. in this teaching is provided regarding tracheostomy care and demonstration of tracheostomy care is will be given to the caregivers. for 15-20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Care givers who will be:
1. Age of 18-70 yrs.
2. Cooperative
3. Able to understand Hindi or English language.
4. Having formal education up to 5th standard and above |
|
| ExclusionCriteria |
| Details |
Care givers who will:
1. Having sensory deficit, neurological deficit.
2. Caregivers from medical field, nursing profession and having previous
knowledge about tracheostomy care. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in the knowledge scores and skills scores |
At day 1 and day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
association of knowledge and skills acquired with their selected socio
demographic variables |
At day 1 and day 3 |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
16/09/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A Quasi-experimental study to assess the effectiveness of standardized hands on training regarding tracheostomy care among the caregivers of tracheostomized patients. In this study the caregivers of patients who are going home with tracheostomy tube in-situ will be selected and pre test will be taken after that intervention will be provided and post test at day 1 and 3 will be taken via knowledge questionnaire and observational checklist. |