A comparative study of sound therapy using a mobile application and therapeutic counseling with cognitive-behavioral methodology and combined therapy on reducing tinnitus annoyance in people with chronic tinnitus
A comparative study of sound therapy using a mobile application and therapeutic counseling with cognitive-behavioral methodology and combined therapy on reducing tinnitus annoyance in people with chronic tinnitus
Design
This study is designed as a randomized clinical trial with three parallel groups. Participants will be randomly assigned to three groups: the first group will receive sound therapy using a mobile application, the second group will receive CBT counseling, and the third group will receive a combination treatment, i.e., the two methods of using sound therapy using a mobile application and CBT counseling. The research design will be a pre-test-post-test with a 3-month follow-up. The target population of this study is adults aged 18 to 65 years with chronic tinnitus (more than 6 months) who refer to the ENT clinics of Loghman Hakim Hospital and then will be referred to the hospital's audiology department for research.
Settings and conduct
Loghman Hakim Hospital, Audiology Department
Participants/Inclusion and exclusion criteria
1- People with moderate to severe chronic tinnitus 36 ≤ THI
2- Tinnitus duration more than 6 months
3- People aged between 18 and 65
4- Access to a smartphone with software registration capability
5- Having a high school diploma or higher
Intervention groups
1- People receiving sound therapy
2- People receiving counseling therapy
3- People receiving combination therapy
Main outcome variables
Reducing the intensity and severity of tinnitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260519069452N1
Registration date:2026-06-03, 1405/03/13
Registration timing:prospective
Last update:2026-06-03, 1405/03/13
Update count:0
Registration date
2026-06-03, 1405/03/13
Registrant information
Name
AYUB VALADBEIGI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1721
Email address
a_valadbeigi@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-06-05, 1405/03/15
Expected recruitment end date
2027-01-05, 1405/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of sound therapy using a mobile application and therapeutic counseling with cognitive-behavioral methodology and combined therapy on reducing tinnitus annoyance in people with chronic tinnitus
Public title
Tinnitus treatments
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People with tinnitus
Chronic, annoying tinnitus
Exclusion criteria:
Conductive hearing loss
Using hearing aids
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the nature of the experiment, a simple randomization method is used using sealed envelopes containing random numbers equal to the number of subjects studied.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran, Imam Hossein (AS) Square, Damavand Street (New Tehran), opposite Bu Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, First Floor, Audiology Department
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2026-05-17, 1405/02/27
Ethics committee reference number
IR.SBMU.RETECH.REC.1405.074
Health conditions studied
1
Description of health condition studied
tinnitus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tinnitus severity
Timepoint
Initial evaluation, final evaluation after 3 months