| CTRI Number |
CTRI/2026/01/101067 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of the TRACHEA communication technique on communication among tracheostomy patients. |
|
Scientific Title of Study
|
A study to assess the effectiveness of the TRACHEA technique on communication among tracheostomy patients in selected hospital in Udupi district, Karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hrithik Chand |
| Designation |
M.Sc. Nursing |
| Affiliation |
Manipal College of Nursing |
| Address |
4th floor, Room no: 400A, Manipal college of Nursing, Madhav Nagar, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8217391758 |
| Fax |
|
| Email |
hrithikchand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
5th floor, Room no:507, Manipal college of Nursing, Madhav Nagar, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
|
| Email |
elsa.sana@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
5th floor, Room no:507, Manipal college of Nursing, Madhav Nagar, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
|
| Email |
elsa.sana@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Madhava Nagar, Manipal-576104 Udupi District, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Hrithik Chand |
| Address |
4th floor, Room no: 400A, Manipal college of Nursing, Madhav Nagar, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104,India |
| Type of Sponsor |
Other [Self funded ( no external sponsor )] |
|
|
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 Suresh Pillai |
Kasturba Hospital, Manipal |
3rd floor ENT wards (R9 R7),Room no-301 and 304, Shiridi Saibaba Block, Kasturba Hospital, Manipal, Udupi, Karnataka, 576104, India
Udupi
KARNATAKA |
9901728977
suresh.pillai@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College Institutional Ethics Committe 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable, no control group |
| Intervention |
TRACHEA technique |
‘TRACHEA’ technique is communication technique which includes two elements, i.e., the indicator finger
which is made up of silicon and an indicator module which beeps and lights up when the patient activates it or presses it on a hard surface.
The second element is the ‘TRACHEA’ cards, consisting of 25 cards which express emotions, actions and needs of the patient and are self-developed cards.
Using these two elements, i.e., the indicator and the cards, patients communicate with the nurses and healthcare providers.
making the nonverbal commuincation much effective. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients planned for a tracheostomy.
2) Patients aged 18 years and above.
3) Patients planned for discharge with tracheostomy.
4) Patients who are conscious and orientated.
|
|
| ExclusionCriteria |
| Details |
1) Patients who are heavily sedated |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge level regarding TRACHEA technique, communication and usability of the TRACHEA technique |
knowledge level regarding TRACHEA technique – preoperative baseline
postoperative - day 4
communication – preoperative baseline
postoperative- day 4
usability of TRACHEA technique preoperative baseline
postoperative - day 4
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
26/01/2026 |
| 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 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
|
Tracheostomy patients often experience significant communication difficulties due to the loss of vocal function, which can lead to frustration, anxiety, and impaired interaction with caregivers. Effective communication is vital for ensuring patient safety, comfort, and quality of care. This study aims to assess the effectiveness of the ‘TRACHEA’ technique, an innovative communication strategy designed to enhance interaction between tracheostomy patients and healthcare providers. This one-group pretest–posttest study will be conducted in the R7 and R9 wards of a tertiary hospital in Udupi district, Karnataka, from October 2025 to October 2026. A total of 57 patients meeting the inclusion criteria will be recruited through purposive sampling. Data will be collected using five tools:
1) Demographic proforma – patient background details. 2) Clinical proforma – patient disease condition details. 3) ’TRACHEA’ knowledge questionnaire. (self-developed) 4) ‘TRACHEA’ checklist. (self-developed) 5) ’TRACHEA’ rubrics. (self-developed)
Data will be analysed using descriptive and inferential statistics (t-test, ANOVA, chi-square) with Jamovi software at 5% level of significance. The study poses minimal risk but has the potential to benefit from improved communication, reduced anxiety, greater patient satisfaction, and safer, more patient-centred care for tracheostomy patients. |