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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NRF 2022R1H1A2091291 |
| Sponsor | National Research Foundation of Korea |
| Funder | National Research Foundation of Korea |
- 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
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
Contact information
Scientific
1, Hallymdaehak-gil
Chuncheon-si
24252
Korea, South
 ORCID ID |
0009-0002-7142-3978 |
|---|---|
| Phone | +82 (0)1047486913 |
| eaeno@naver.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of tinnitus improvement between video-viewing of tinnitus counseling contents and group counseling |
| Study objectives | The 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) studied | Chronic subjective tinnitus |
| Intervention | Participants 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 type | Behavioural |
| Primary outcome measure(s) | 1. 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 |
| Key secondary outcome measure(s) | 1. Hearing threshold is measured using pure-tone audiometry (decibels) at baseline 2. Tinnitus frequency and loudness measured using tinnitogram (Herz and decibels) at baseline |
| Completion date | 18/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 36 |
| Total final enrolment | 36 |
| Key inclusion criteria | 1. 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 criteria | 1. Psychiatric illness 2. Involvement in tinnitus-related litigation |
| Date of first enrolment | 01/08/2023 |
| Date of final enrolment | 31/10/2023 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Chuncheon
24252
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The 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? |
|---|---|---|---|---|---|
| Results article | 24/06/2024 | 09/07/2024 | Yes | No | |
| Participant information sheet | 03/07/2023 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
