Clinical trial NCT06360731: The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: 4-7-8 breathing exercise
Tinnitus
Psychological factors
Insomnia
Informative session
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a parallel group randomised controlled trial design.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Baseline
measure: Visual Analog Scale (VAS)
timeFrame: Six weeks after baseline evaluation
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Baseline
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Six weeks after baseline evaluation
measure: Insomnia severity index (ISI)
timeFrame: Baseline
measure: Insomnia severity index (ISI)
timeFrame: Six weeks after baseline evaluation
measure: Perceived stress scale -10 (PSS-10)
timeFrame: Baseline
measure: Perceived stress scale -10 (PSS-10)
timeFrame: Six weeks after baseline evaluation
measure: Trait Anxiety Scale (TAS)
timeFrame: Baseline
measure: Trait Anxiety Scale (TAS)
timeFrame: Six weeks after baseline evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gokce Saygi Uysal
city: Izmir
country: Turkey
facility: Audiology Unit of the Department of Otorhinolaryngology, Ege University Faculty of Medicine Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Video: breathing exercises: 4-7-8 breath [Internet]. 2014 Available from: https://www.drweil.com/videos-features/videos/breathing-exercises-4-7-8-breath/
citation: Aksoy S, Firat Y, Alpar R. The Tinnitus Handicap Inventory: a study of validity and reliability. Int Tinnitus J. 2007;13(2):94-8.
citation: 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.
citation: 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.
citation: Öner N, Lecompte A. Manual of state trait anxiety inventory. Istanbul: Boğaziçi University Print House; 1998.