| CTRI Number |
CTRI/2024/09/074218 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of hearing status and cognitive parameters of children undergoing ear surgeries which aims at eradicating the disease process and improve hearing ability |
|
Scientific Title of Study
|
Prospective assessment of auditory and cognitive performance in children undergoing ear surgeries: A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Adwitiya Kashyap Jha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Otorhinolaryngology and Head & Neck surgery, Ansari Nagar East, All India Institute of Medical Sciences, New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9910094077 |
| Fax |
|
| Email |
dwtkshp5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shuchita Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Otorhinolaryngology and Head & Neck Surgery, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
DELHI
110029
India |
| Phone |
9910094077 |
| Fax |
|
| Email |
drshuch@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Adwitiya Kashyap Jha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Otorhinolaryngology and Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi
DELHI
110029
India |
| Phone |
9910094077 |
| Fax |
|
| Email |
dwtkshp5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Adwitiya Kashyap Jha,
Junior Resident,
Department of Otorhinolaryngology and Head & Neck surgery, New Delhi. Pin Code - 110029 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Otorhinolaryngology and Head & Neck surgery, New Delhi. Pin Code - 110029 |
| Type of Sponsor |
Government 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 |
| Dr Adwitiya Kashyap Jha |
All India Institute of Medical Sciences |
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi. Pin code - 110029
New Delhi
DELHI |
9910094077
dwtkshp5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H650||Acute serous otitis media, (2) ICD-10 Condition: H662||Chronic atticoantral suppurative otitis media, (3) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Tympanoplasty
2. Mastoidectomy
3. Tympanotomy with Grommet Insertion |
Patients after their pre-operative assessment of the below mentioned parameters :-
1. P.T.A of patient
2. Speech Audiometry of patient
3. Impedance of patient
4. Multi-dimensional voice program analysis (MDVP) of patient and caregiver
5. Hindi mental state examination questionnaire (HMSE)11 of patient
6. Glasgow benefit inventory scale of patient
7. Trail making of patient 8. Color Wood Stroop task of patient
9. Caregiver’s burden questionnaire
10. Caregivers Samples taken for Serum cortisol level
Patients will then under Surgeries based on their Diagnosis.
- Cases of Mucosal Type Chronic Otitis Media will under Tympanoplasty
- Cases of Squamous type Chronic Otitis Media will under Mastoidectomy +/- Tympanoplasty
- Cases with Otitis media with effusion will undergo Tympanotomy with Grommet insertion
-- These intervention will be done for the assessment of outcomes of parameters, 3 months after the surgeries are done. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Age less than 14 years
2. Patients undergoing select ear surgeries like Tympanoplasty, Mastoidectomy and Myringotomy with or without Grommet insertion between July 2024 to December 2026
3. Child is able to perform cognitive function tests
|
|
| ExclusionCriteria |
| Details |
1. Patients with mixed hearing loss/sensory neural hearing loss (SNHL).
2. Complicated CSOM
3. Presence of neuro-psychological disorders
4. Revision surgery
5. Syndromic condition
6. Caretakers not giving consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. P.T.A
2. Speech Audiometry
3. Impedance |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Multi-dimensional voice program analysis (MDVP)
2. Hindi mental state examination questionnaire (HMSE)11
3. Glasgow benefit inventory scale
4. Trail making
5. Color Wood Stroop task
|
3 months |
1. Caregiver’s burden questionnaire
2. Serum cortisol level |
3 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
15/10/2024 |
| 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="2"
Months="6"
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 - YES
- What data in particular will be shared?
Response (Others) - Statistical data
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dwtkshp5@gmail.com].
- For how long will this data be available start date provided 07-01-2027 and end date provided 07-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Day of Evaluation and Admission:-
Patient taken up for:-
History
Examination - Ear examination and Tuning fork test
Patient sent to Audiologist for:
1. P.T.A
2. Speech Audiometry
3. Impedance
Patient and caregiver both sent to Voice clinic for:
1. Multi-dimensional voice program analysis (MDVP)
Patient will be administered
1. Hindi mental state examination questionnaire (HMSE)11
2. Glasgow benefit inventory scale
Objective cognitive function tests - 1) Trail making
2) Color Wood Stroop task
Will be given the form, be asked to fill it and bring on the
day of operation
Caregivers Administered – 1. Caregiver’s burden
questionnaire
2. Samples taken for Serum cortisol level
Day of Surgery
Collection of –
Audiological reports
– Questionnaire and task sheets
Postoperatively, all patients will be given intravenous/oral
antibiotics, analgesics and antihistaminic for 14 days
Follow up advice will be given after 3 months to the patient
as well as to the caregivers
3rd Month Post Surgery
Patient sent to Audiologist for:
1. P.T.A
2. Speech Audiometry
3. Impedance
Patient and caregiver both sent to Voice clinic for:
1. Multi-dimensional voice program analysis (MDVP)
Patient will be administered
1. Hindi mental state examination questionnaire (HMSE)11
2. Glasgow benefit inventory scale
Objective cognitive function tests - 1) Trail making
2) Color Wood Stroop task
Will be given the form, be asked to fill it and bring on the
day of operation
Caregivers Administered –
1. Caregiver’s burden questionnaire
2. Samples taken for Serum cortisol level
Total duration of intervention - 3 months
|