Effectiveness of group counseling and information provision via video clips in improving tinnitus: a comparative study

ISRCTN ISRCTN15292645
DOI https://doi.org/10.1186/ISRCTN15292645
Secondary identifying numbers NRF 2022R1H1A2091291
Submission date
02/07/2023
Registration date
03/07/2023
Last edited
09/07/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Tinnitus is the name for hearing noises that do not come from an outside source. Counseling is considered a treatment option for people with subjective tinnitus. Several studies on counseling for tinnitus have reported that some participants, but not all, show significant relief from tinnitus. Furthermore, some participants show improvement in tinnitus distress even when tinnitus education counseling is conducted without the intervention of a hearing professional. Currently, YouTube is the most popular platform for obtaining information, with abundant tinnitus-related content. However, evidence is lacking on the effectiveness of providing tinnitus information to individuals with tinnitus via video.

Who can participate?
People with chronic subjective tinnitus

What does the study involve?
Participants will be randomly allocated into two groups according to treatment type (viewing tinnitus counseling content or counseling) for 2 weeks. The tinnitus counseling content contains 100 questions and answers, including suggestions from tinnitus experts, and identified difficulties, questions, and misunderstandings in daily life for 74 people diagnosed with tinnitus in a previous study. The group counseling group will receive a total of six sessions over 2 weeks, and the video content viewing group will watch seven or eight video clips on a new topic every day. Participants complete a number of tests and questionnaires 2 weeks before baseline, at baseline, and after treatment.

What are the possible benefits and risks of participating?
Participants may experience reduced tinnitus annoyance or adverse tinnitus. There are no risks expected.

Where is the study run from?
Hallym University (South Korea)

When is the study starting and how long is it expected to run for?
June 2023 to June 2024

Who is funding the study?
National Research Foundation of Korea (NRF) (South Korea)

Who is the main contract?
Prof. In-Ki Jin, inkijin@hallym.ac.kr

Study website

Contact information

Miss Sumin Lee
Scientific

1, Hallymdaehak-gil
Chuncheon-si
24252
Korea, South

ORCiD logoORCID ID 0009-0002-7142-3978
Phone +82 (0)1047486913
Email eaeno@naver.com

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual, Laboratory, Telephone
Study typeTreatment
Study type Participant information sheet
Scientific titleComparison of tinnitus improvement between video-viewing of tinnitus counseling contents and group counseling
Study objectivesThe counseling group may have greater tinnitus relief than the group viewing tinnitus counseling content, which is delivered in the form of video clips without interaction with an audiologist. However, the tinnitus counseling group may have shown some improvement in tinnitus.
Ethics approval(s)

Approved 19/06/2023, The Institutional Review Board of Hallym University (Hallym University 1, Hallymdaehak-gil, Chuncheon, 24252, Korea, South; No telephone number provided; irb@hallym.ac.kr), ref: HIRB-2023-043

Health condition(s) or problem(s) studiedChronic subjective tinnitus
InterventionParticipants with chronic subjective tinnitus will be randomized into two groups according to treatment type (viewing tinnitus counseling content group and counseling group) for 2 weeks. The tinnitus counseling content utilized at this time contained 100 questions and answers, including suggestions from tinnitus experts, and identified difficulties, questions, and misunderstandings in daily life for 74 people diagnosed with tinnitus in a previous study. The group counseling group will receive a total of six sessions over 2 weeks, and the video content viewing group will watch seven or eight video clips on a new topic every day. The effectiveness of each group will be checked based on changes in the Visual Analog Scale for annoyance and loudness score, the Korean version of the Tinnitus Primary Function Questionnaire score.

Participants were randomly allocated to groups using an Excel spreadsheet (Microsoft, Redmond, Washington, USA). This randomization program assigned 36 participants (numbers 1 to 36) and randomly changed their order. Those assigned numbers 1 to 18 were assigned to the Group Counseling Group, while those assigned numbers 19 to 36 were assigned to the video content viewing group.
Intervention typeBehavioural
Primary outcome measure1. Loudness and annoyance of tinnitus measured using the visual analog scale (100 points) at 2 weeks before baseline, baseline, and post-treatment
2. Quality of life impairment due to tinnitus measured using the Korean version of the Tinnitus Primary Function Questionnaire (K-TPFQ, 100 points) at 2 weeks before baseline, baseline, and post-treatment
Secondary outcome measures1. Hearing threshold is measured using pure-tone audiometry (decibels) at baseline
2. Tinnitus frequency and loudness measured using tinnitogram (Herz and decibels) at baseline
Overall study start date19/06/2023
Completion date18/06/2024

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit19 Years
Upper age limit75 Years
SexBoth
Target number of participants36
Total final enrolment36
Key inclusion criteria1. Presence of discomfort or difficulty due to tinnitus
2. Average score of the Korean version of Tinnitus Primary Function Questionnaire (K-TPFQ) >30 points
3. Not receiving other tinnitus treatments or counseling
4. Familiarity with smartphones or the Internet
Key exclusion criteria1. Psychiatric illness
2. Involvement in tinnitus-related litigation
Date of first enrolment01/08/2023
Date of final enrolment31/10/2023

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Hallym University
1 Hallimdaehak-gil
Chuncheon
24252
Korea, South

Sponsor information

National Research Foundation of Korea
Government

201, Gajeong-Ro, Yuseong-Gu
Daejeon
34113
Korea, South

Phone +82 (0)42 869 6114
Email basicresearch@nrf.re.kr
Website https://www.nrf.re.kr/eng/index
ROR logo "ROR" https://ror.org/013aysd81

Funders

Funder type

Government

National Research Foundation of Korea
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
한국연구재단이 창의적 연구와, National Research Foundation (South Korea), NRF
Location
Korea, South

Results and Publications

Intention to publish date18/07/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planResearch using this data will be published in a peer-reviewed hearing journal.
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from In-Ki Jin (inkijin@hallym.ac.kr).
The type of data that will be shared: Excel spreadsheet
Dates of availability: 01/01/2024
Whether consent from participants was required and obtained: Yes
Comments on data anonymization: The data will be anonymized

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 03/07/2023 No Yes
Results article 24/06/2024 09/07/2024 Yes No

Editorial Notes

09/07/2024: Publication reference added.
12/01/2024: The study contact was updated.
10/10/2023: The total final enrolment was changed from 47 to 36.
29/08/2023: The final enrolment number has been added.
03/07/2023: Study's existence confirmed by the Institutional Review Board of Hallym University.