Determining the effect of face-to-face and remote rehabilitation in the treatment of tinnitus
Design
This is a randomized clinical trial, in which 15 eligible patients will be randomly assigned to the intervention 1 and intervention 2 groups
Settings and conduct
The eligible patients with chronic tinnitus referring to the Audiology Clinic in Hamedan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention 1 and intervention 2 groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 70 years, Non-pulsatile chronic tinnitus for more than 6 months, Being right-handed, Exclusion criteria: Hyperacusis, Use of hearing aids, Psychological disorders, Active diseases of the ear and nervous system
Intervention groups
Intervention group 1: visiting the audiology clinic for 24 sessions of 60 minutes during 12 weeks (twice a week). Listening bilaterally to wide band noise about 30 minutes with headphones and then a 30-minute counseling session in each session. Intervention group 2: 24 sessions of 60 minutes of counseling and sound therapy without attending the clinic. Listening bilaterally to wide band noise (white noise) for about 30 minutes with hands-free and then receiving counseling by making a video connection with Google Mate for 30 minutes.
Investigating the effect of face-to-face and remote rehabilitation on the treatment of tinnitus
Public title
face-to-face and remote rehabilitation on the treatment of tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years, Non-pulsatile tinnitus for more than 6 months, Being right-handed,
Exclusion criteria:
Hyperoccosis, Use of hearing aids, Psychological disorders, Active diseases of the ear and nervous system
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention 1" on one sheet and "intervention 2" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention 1 or intervention 2 groups; Concealment: with opaque sealed envelopes in a random sequence
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Research square, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2024-10-05, 1403/07/14
Ethics committee reference number
IR.UMSHA.REC.1403.447IR.UMSHA.REC.1403.447
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Tinnitus handicap
Timepoint
Before intervention and after 12 , 16 weeks after the start of the intervention
Method of measurement
Using the Tinnitus Handicap Inventory (THI) questionnaire
2
Description
Tinnitus annoyance
Timepoint
Before intervention and after 12 , 16 weeks after the start of the intervention
Method of measurement
Using visual analog scale (VAS)
3
Description
Tinnitus loudness
Timepoint
Before intervention and after 12 , 16 weeks after the start of the intervention
Method of measurement
Based on psycho-acoustic assessment
4
Description
tinnitus pitch
Timepoint
Before intervention and after 12 , 16 weeks after the start of the intervention
Method of measurement
Based on psycho-acoustic assessment
Secondary outcomes
empty
Intervention groups
1
Description
Control group: visiting the audiology clinic for 24 sessions of 60 minutes during 12 weeks (twice a week). Listening bilaterally to wide band noise about 30 minutes with headphones and then a 30-minute counseling session in each session.
Category
Rehabilitation
2
Description
Intervention group: 24 sessions of 60 minutes of counseling and sound therapy without attending the clinic. Listening bilaterally to wide band noise (white noise) for about 30 minutes with hands-free and then receiving counseling by making a video connection with Google Mate for 30 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
2
Recruitment center
Name of recruitment center
Audiology Clinic in Hamadan city
Full name of responsible person
Maryam Emadi
Street address
Shahid Fahmideh St., Hamedan University of Medical Sciences, Faculty of Rehabilitation Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 1571
Email
maryamemadi1396@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan, Shahid Fahmideh Blvd., University Headquarters, 4th Floor, Vice-Chancellor for Research and Technology
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Emadi
Position
Assistant Professor of Audiology
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
maryamemadi1396@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Emadi
Position
Assistant Professor of Audiology
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
maryamemadi1396@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Bahareh Khavarghazalani
Position
Assistant Professor of Audiology
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1571
Fax
Email
b.khavarghazalani@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Reporting as a papers
When the data will become available and for how long
2026 and after
To whom data/document is available
All people
Under which criteria data/document could be used
Research plan: In accordance with Hamadan University of Medical Sciences copyright Paper: In accordance with the journal's policies to access the published paper
From where data/document is obtainable
Research plan: The library of the School of Rehabilitation, UMSHA Papers: Databases
What processes are involved for a request to access data/document
For the research plan, studying in the library For papers depends on the journal's policy.