CompletedNot Applicable

The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus

Turkey (Türkiye)48 participantsStarted 2024-03-18

Plain-language summary

The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality. There will be a parallel-group randomized controlled trial study and consists of two groups. Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks. Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory, and perceived stress scale will be applied before and after the application.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged between 18-65 years with subjective idiopathic tinnitus complaints for at least six months * Must be able to speak and read Turkish * Must be able to answer the questionnaire questions and perform the 4-7-8 breathing exercises regularly Exclusion Criteria: * Any neuro-otologic, psychiatric, neurologic, or cognitive problems, objective tinnitus, chronic medication use, asthma diagnosis or respiratory distress * Receivement of any tinnitus treatment or tinnitus informative session actively

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analog Scale (VAS)

Timeframe: Baseline

Visual Analog Scale (VAS)

Timeframe: Six weeks after baseline evaluation

Tinnitus Handicap Inventory (THI)

Timeframe: Baseline

Tinnitus Handicap Inventory (THI)

Timeframe: Six weeks after baseline evaluation

Insomnia severity index (ISI)

Timeframe: Baseline

Insomnia severity index (ISI)

Timeframe: Six weeks after baseline evaluation

Perceived stress scale -10 (PSS-10)

Timeframe: Baseline

Perceived stress scale -10 (PSS-10)

Timeframe: Six weeks after baseline evaluation

Trial details

NCT IDNCT06360731

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-07

View on ClinicalTrials.gov More Tinnitus, Subjective trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Visual Analog Scale (VAS)

Timeframe: Baseline

Visual Analog Scale (VAS)

Timeframe: Six weeks after baseline evaluation

Tinnitus Handicap Inventory (THI)

Timeframe: Baseline

Tinnitus Handicap Inventory (THI)

Timeframe: Six weeks after baseline evaluation

Insomnia severity index (ISI)

Timeframe: Baseline

Insomnia severity index (ISI)

Timeframe: Six weeks after baseline evaluation

Perceived stress scale -10 (PSS-10)

Timeframe: Baseline

Perceived stress scale -10 (PSS-10)

Timeframe: Six weeks after baseline evaluation