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NCT Number: NCT06360731

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

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.

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Key information

Conditions

Tinnitus, Subjective Dyssomnias Ear Diseases Hearing Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Tinnitus

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gokce Saygi Uysal, Ankara, Turkey (Türkiye)

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About this study

The aim of this study is to evaluate the effect of 4-7-8 breathing exercise technique on tinnitus handicap, psychological factors and sleep quality. It is also aimed to compare the results of the experimental group and those who received only 1 hour of informative session on tinnitus (Control group).

The study will employ a parallel-group randomized controlled trial design. 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 to all patients before and after the application.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4-7-8 breathing exercise technique and informative session on tinnitus

Other

Participants in experimental group will be individually provided with informative session on tinnitus for one hour by researchers. During the informative session, the participants will be given general information about tinnitus and will be informed about the possible causes, symptoms, diagnosis, therapy, or treatment processes, and coping methods. The participants will be also given a printed informative brochure on tinnitus. In the same session, after one hour of informative session, the 4-7-8 breathing exercise method will be demonstrated by the same researchers. In addition, a video showing how to perform the 4-7-8 breathing exercise technique will be sent as a text message to their cell phones.

Informative session on tinnitus

Other

Participants in control group will be individually provided with informative session on tinnitus only for one hour by researchers G.K. and G.S.U. from both clinics. During the informative session, the participants will be given general information about tinnitus and inform about the possible causes, symptoms, diagnosis, therapy, or treatment processes, and coping methods. The participants will be also given a printed informative brochure on tinnitus.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Baseline

    Patients will be asked to assess the degree of distress and annoyance associated with their tinnitus, as well as its severity, using a Visual Analog Scale (VAS) from 0 to 10 both before and after the application. An increase in these areas is shown by an increase in the score. Minimum score value is 0 and maximum value is 10. All patients will be assessed before application.

  2. Visual Analog Scale (VAS)

    Time frame: Six weeks after baseline evaluation

    Patients will be asked to assess the degree of distress and annoyance associated with their tinnitus, as well as its severity, using a Visual Analog Scale (VAS) from 0 to 10 both before and after the application. An increase in these areas is shown by an increase in the score. Minimum score value is 0 and maximum value is 10. All patients will be assessed six weeks after baseline evaluation.

  3. Tinnitus Handicap Inventory (THI)

    Time frame: Baseline

    The Tinnitus Handicap Inventory (THI) assesses the catastrophic, emotional, and functional impacts of tinnitus and measures its effects on patients' daily functioning. The THI consists of 25 items. In the inventory, there are 25 items consisting of three options as 'yes', 'no', and 'sometimes'. A 'yes' answer is worth 4 points and a 'no' answer is worth 0 points. A maximum score of 100 points can be obtained from the THI. The higher the score, the greater the perception of the tinnitus as a handicap. Minimum score value is 0 and maximum value is 100. All patients will be assessed before application.

  4. Tinnitus Handicap Inventory (THI)

    Time frame: Six weeks after baseline evaluation

    The Tinnitus Handicap Inventory (THI) assesses the catastrophic, emotional, and functional impacts of tinnitus and measures its effects on patients' daily functioning. The THI consists of 25 items. In the inventory, there are 25 items consisting of three options as 'yes', 'no', and 'sometimes'. A 'yes' answer is worth 4 points and a 'no' answer is worth 0 points. A maximum score of 100 points can be obtained from the THI. The higher the score, the greater the perception of the tinnitus as a handicap. Minimum score value is 0 and maximum value is 100. All patients will be assessed six weeks after baseline evaluation.

  5. Insomnia severity index (ISI)

    Time frame: Baseline

    Sleep quality of the patients was assessed with the insomnia severity index (ISI). It is a questionnaire that evaluates the difficulties experienced in transitioning to and maintaining sleep, the level of stress caused by sleep problems, and impairments in daily functions, and thus determines the level of insomnia. It consists of 7 questions in total. Higher score indicates more insomnia symptoms. Minimum score value is 0 and maximum value is 28. All patients will be assessed before application.

  6. Insomnia severity index (ISI)

    Time frame: Six weeks after baseline evaluation

    Sleep quality of the patients was assessed with the insomnia severity index (ISI). It is a questionnaire that evaluates the difficulties experienced in transitioning to and maintaining sleep, the level of stress caused by sleep problems, and impairments in daily functions, and thus determines the level of insomnia. It consists of 7 questions in total. Higher score indicates more insomnia symptoms. Minimum score value is 0 and maximum value is 28. All patients will be assessed six weeks after baseline evaluation.

  7. Perceived stress scale -10 (PSS-10)

    Time frame: Baseline

    The Perceived Stress Scale-10 (PSS-10) will be administered to assess the stress perceived by tinnitus patients. It was developed to measure the extent to which situations in one's life are considered stressful. It consists of 10 questions. The scores of PSS-10 vary between 0 and 40. Greater perceived stress is indicated by higher scores. The scores of PSS-10 vary between 0 and 40. All patients will be assessed before application.

  8. Perceived stress scale -10 (PSS-10)

    Time frame: Six weeks after baseline evaluation

    The Perceived Stress Scale-10 (PSS-10) will be administered to assess the stress perceived by tinnitus patients. It was developed to measure the extent to which situations in one's life are considered stressful. It consists of 10 questions. The scores of PSS-10 vary between 0 and 40. Greater perceived stress is indicated by higher scores. The scores of PSS-10 vary between 0 and 40. All patients will be assessed six weeks after baseline evaluation.

  9. Trait Anxiety Scale (TAS)

    Time frame: Baseline

    The trait anxiety subscale of the State-Trait Anxiety Inventory was used to assess the level of anxiety in those with tinnitus. The TAS is a 4-point Likert-type scale consisting of twenty items that aims to determine how the individual feels regardless of the situation and conditions in which they find themselves. A score between 20 and 80 is obtained from this scale. Higher scores indicate higher level of anxiety. A score between 20 and 80 is obtained from this scale. All patients will be assessed before application.

  10. Trait Anxiety Scale (TAS)

    Time frame: Six weeks after baseline evaluation

    The trait anxiety subscale of the State-Trait Anxiety Inventory was used to assess the level of anxiety in those with tinnitus. The TAS is a 4-point Likert-type scale consisting of twenty items that aims to determine how the individual feels regardless of the situation and conditions in which they find themselves. A score between 20 and 80 is obtained from this scale. Higher scores indicate higher level of anxiety. A score between 20 and 80 is obtained from this scale. All patients will be assessed six weeks after baseline evaluation.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus Handicap, Psychological Factors, and Sleep Quality in Tinnitus Patients: A Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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