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

NCT06360731 | Completed

• 1 other identifier: 1018
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tinnitus, Subjective

Keywords

4-7-8 breathing exercise; Tinnitus; Psychological factors; Insomnia; Informative session

Outcome Measures

Primary Outcomes (10)

• Visual Analog Scale (VAS)

  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.

  Baseline

• Visual Analog Scale (VAS)

  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.

  Six weeks after baseline evaluation

• Tinnitus Handicap Inventory (THI)

  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.

  Baseline

• Tinnitus Handicap Inventory (THI)

  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.

  Six weeks after baseline evaluation

• Insomnia severity index (ISI)

  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.

  Baseline

• Insomnia severity index (ISI)

  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.

  Six weeks after baseline evaluation

• Perceived stress scale -10 (PSS-10)

  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.

  Baseline

• Perceived stress scale -10 (PSS-10)

  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.

  Six weeks after baseline evaluation

• Trait Anxiety Scale (TAS)

  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.

  Baseline

• Trait Anxiety Scale (TAS)

  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.

  Six weeks after baseline evaluation

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental group who consists of subjective tinnitus patients will receive 1 hour of informative session on tinnitus and also perform 4-7-8 breathing exercises for 6 weeks

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

Control Group

ACTIVE COMPARATOR

Control group who consists of subjective tinnitus patients will receive 1 hour of informative session on tinnitus only

Other: Informative session on tinnitus

Interventions

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.

Experimental Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

Gokce Saygi Uysal

Ankara, Turkey (Türkiye)

Location

Audiology Unit of the Department of Otorhinolaryngology, Ege University Faculty of Medicine Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (11)

• Koksoy S, Eti CM, Karatas M, Vayisoglu Y. The Effects of Yoga in Patients Suffering from Subjective Tinnitus. Int Arch Otorhinolaryngol. 2018 Jan;22(1):9-13. doi: 10.1055/s-0037-1601415. Epub 2017 Apr 3.

  PMID: 29379573 BACKGROUND

• Vierra J, Boonla O, Prasertsri P. Effects of sleep deprivation and 4-7-8 breathing control on heart rate variability, blood pressure, blood glucose, and endothelial function in healthy young adults. Physiol Rep. 2022 Jul;10(13):e15389. doi: 10.14814/phy2.15389.

  PMID: 35822447 BACKGROUND

• Gilles A, Jacquemin L, Cardon E, Vanderveken OM, Joossen I, Vermeersch H, Vanhecke S, Van den Brande K, Michiels S, Van de Heyning P, Van Rompaey V. Long-term effects of a single psycho-educational session in chronic tinnitus patients. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3301-3307. doi: 10.1007/s00405-021-07026-7. Epub 2021 Oct 1.

  PMID: 34596715 RESULT

• Apoorva HM, Jayaram M, Patil NJ. Usefulness of Yoga in the management of tinnitus during COVID-19: A narrative review. J Ayurveda Integr Med. 2024 Jan-Feb;15(1):100822. doi: 10.1016/j.jaim.2023.100822. Epub 2023 Dec 28.

  PMID: 38157657 RESULT

• Ismail AMA, Ali SM, Ghuiba K, Elfahl AMA, Tolba AMN, Ghaleb HAM. Autonomic functions, tinnitus annoyance and loudness, and quality of life: Randomized-controlled responses to bee-humming (vibrational) respiratory training in tinnitus elderly. Complement Ther Clin Pract. 2022 Aug;48:101611. doi: 10.1016/j.ctcp.2022.101611. Epub 2022 Jun 3.

  PMID: 35675742 RESULT

• Gunjawate DR, Ravi R. Effect of yoga and meditation on tinnitus: a systematic review. J Laryngol Otol. 2021 Apr;135(4):284-287. doi: 10.1017/S0022215121000566. Epub 2021 Mar 11.

  PMID: 33691808 RESULT

• Video: breathing exercises: 4-7-8 breath [Internet]. 2014 Available from: https://www.drweil.com/videos-features/videos/breathing-exercises-4-7-8-breath/

  RESULT

• Aksoy S, Firat Y, Alpar R. The Tinnitus Handicap Inventory: a study of validity and reliability. Int Tinnitus J. 2007;13(2):94-8.

  PMID: 18229787 RESULT

• Boysan M, Güleç M, Beşiroğlu L, et al. Psychometric properties of the Insomnia Severity Index in Turkish sample. Anadolu Psikiyatri Derg 2010;11:248-252.

  RESULT

• Eskin M, Harlak H, Demirkıran F. The adaptation of the perceived stress scale into turkish: a reliability and validity analysis. Neuropsych Investig 2013;51:132-140.

  RESULT

• Öner N, Lecompte A. Manual of state trait anxiety inventory. Istanbul: Boğaziçi University Print House; 1998.

  RESULT

MeSH Terms

Conditions

Tinnitus; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In the study, patients do not know which group they were in. Therefore, blinding is performed among the participants. To prevent bias in the study, blinding is also performed between the researchers. Researchers (S.B. and A.O. from both clinics) make the pre- and post-test evaluations without knowing which group the patients are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.

Model Details: This study employs a parallel group randomised controlled trial design.

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 11, 2024
• Study Start: March 18, 2024
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)