- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06785649
The Efficacy of Lavender Herbal Tea in Misophonia
The Effect of Lavender Herbal Tea on the Mental Health of Individuals With Misophonia: A Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Misophonia is a disorder of vocal sensitivity characterized by unusual discomfort with certain sounds. Typical triggers are sounds produced by humans, particularly oral and nasal sounds. These sounds include chewing, slurping, breathing, keyboard sounds, or pen clicks. When individuals with misophonia are exposed to triggers, stimulation of the sympathetic nervous system and emotional distress are observed. Exposure to triggers creates irritation, desire to avoid stimuli, anger, aggression, helplessness, and overwhelm. Stimulation of the sympathetic nervous system leads to physical symptoms such as hypertonia, sweating, and tachycardia. The discomfort and stress caused by misophonia can lead to increased anxiety levels in individuals. At the same time, the emotional distress and discomfort associated with misophonia can trigger depressive symptoms and increase the risk of depression. Concomitant anxiety and depression can worsen the existing symptoms of misophonia and lead to a reduced quality of life.
There is limited empirical evidence evaluating the efficacy of therapeutic approaches to misophonia. Current treatment approaches include cognitive behavioral therapy, acceptance and commitment therapy, and psychotherapies derived from dialectical behavior therapy. Due to the small number of randomized controlled trials, the efficacy of the protocols used in the treatment of misophonia remains unclear. Due to limited resources, problems such as limited access to psychotherapies and early withdrawal from treatment are also observed. Other treatment approaches include pharmacological agents such as selective serotonin reuptake inhibitors (SSRIs), stimulants, antipsychotics, and β-Blockers. Complementary therapies are used due to their potential efficacy, tolerability, possible non-interference, and low cost. Lavender, a complementary treatment intervention, is considered to have anxiolytic, antidepressant, neuroprotective, and anti-inflammatory properties. Lavender is known to positively affect memory, provide alertness, and improve feelings of well-being. Thus, it is seen as an effective herbal medicine intervention in reducing anxiety and depression. Reducing concomitant anxiety and depression may contribute to the improvement of the symptoms of misophonia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sevgi Koroglu, MSc
- Phone Number: 05367982320
- Email: sevgikoroglu@sakarya.edu.tr
Study Contact Backup
- Name: Gülgün Durat, PhD
- Phone Number: 0264 295 66 12
- Email: gdurat@sakarya.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Reporting at least three trigger sounds
- Assessed by a specialist psychiatric nurse and a psychiatrist as humophonia based on the diagnostic criteria for humophonia established by Schröder et al. (2013)
- Individuals aged 18 and over
Exclusion Criteria:
- Allergy to any herbal tea, food or medicine
- Psychiatric illness or chronic illness
- Taking psychiatric medication (such as anxiolytics, and antidepressants)
- Regular use of medication (such as antihypertensive, antidiabetic)
- Regular use of herbal teas or complementary medicines
- Tinnitus and/or hyperacusis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group (lavender herbal tea)
Each participant will be allocated 14 pieces of lavender tea bags of 2 grams, originating from Turkey.
The intervention group will be advised to use 2 g of lavender herb infused in 300 mL hot water for 10-15 minutes in the morning and evening for 14 days.
Participants will be advised to take some time and inhale the scent before drinking the herbal tea.
|
The participant will be allocated 14 pieces of lavender tea bags consisting of 2 grams and originating from Turkey.
During 14 days, the participant will be advised to use 2 g of lavender herb brewed in 300 mL hot water for 10-15 minutes in the morning and evening.
Participants will be able to use 1 lavender tea bag twice a day.
|
|
No Intervention: Control group (wait-list)
No intervention will be applied to the control group for 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Misophonia Scale
Time Frame: Within the first 24 hours after 14 days of lavender tea
|
It is a 30-item self-report scale aiming to assess the severity of misophonia.
The scale is a 5-point Likert-type scale and is graded between 1: Strongly agree and 5: Strongly disagree to 5: Strongly disagree.
The total score range is 30 - 150.
As the score obtained from the scale decreases, the level of misophonia severity decreases.
|
Within the first 24 hours after 14 days of lavender tea
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
Time Frame: Within the first 24 hours after 14 days of lavender tea
|
It is a 21-item self-report inventory aimed at assessing the severity of depression.
The items are rated from 0 to 3 depending on the severity of symptoms.
The total score range is 0 to 63 and is divided into four grades in terms of severity: minimal depression (total score 0-13), mild depression (14-19), moderate depression (20-28) and severe depression (≥ 29).
|
Within the first 24 hours after 14 days of lavender tea
|
|
Anxiety Assessment Scale
Time Frame: Within the first 24 hours after 14 days of lavender tea
|
This scale, which evaluates anxiety, consists of 10 items.
The scale is in 5-point Likert type and is expressed as 1: Never, 2: Very Rarely, 3: Sometimes, 4: Often, 5: Almost Always.
There are no reverse scored items in the scale, the total scale score of anxiety is obtained by summing all items.
The lowest score that can be obtained from the scale is 10 and the highest score is 50.
The higher the total score, the higher the level of anxiety.
|
Within the first 24 hours after 14 days of lavender tea
|
|
Trait Anger Scale (SL-Anger)
Time Frame: Within the first 24 hours after 14 days of lavender tea
|
This scale is an assessment tool that measures how often and at what level individuals feel anger in their lives.
Consisting of 10 items, this test is graded with a four-point Likert type (1=Never, 2=Sometimes, 3=Most of the time, 4=Always).
The increase in the total score obtained from the scale indicates that the individual tends to feel anger more frequently and more intensely in his/her life.
|
Within the first 24 hours after 14 days of lavender tea
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Swedo SE, Baguley DM, Denys D, Dixon LJ, Erfanian M, Fioretti A, Jastreboff PJ, Kumar S, Rosenthal MZ, Rouw R, Schiller D, Simner J, Storch EA, Taylor S, Werff KRV, Altimus CM, Raver SM. Consensus Definition of Misophonia: A Delphi Study. Front Neurosci. 2022 Mar 17;16:841816. doi: 10.3389/fnins.2022.841816. eCollection 2022.
- Brout JJ, Edelstein M, Erfanian M, Mannino M, Miller LJ, Rouw R, Kumar S, Rosenthal MZ. Investigating Misophonia: A Review of the Empirical Literature, Clinical Implications, and a Research Agenda. Front Neurosci. 2018 Feb 7;12:36. doi: 10.3389/fnins.2018.00036. eCollection 2018.
- Erfanian M, Kartsonaki C, Keshavarz A. Misophonia and comorbid psychiatric symptoms: a preliminary study of clinical findings. Nord J Psychiatry. 2019 May-Jul;73(4-5):219-228. doi: 10.1080/08039488.2019.1609086. Epub 2019 May 8.
- Kianpour M, Moshirenia F, Kheirabadi G, Asghari G, Dehghani A, Dehghani-Tafti A. The Effects of Inhalation Aromatherapy with Rose and Lavender at Week 38 and Postpartum Period on Postpartum Depression in High-risk Women Referred to Selected Health Centers of Yazd, Iran in 2015. Iran J Nurs Midwifery Res. 2018 Sep-Oct;23(5):395-401. doi: 10.4103/ijnmr.IJNMR_116_16.
- Firoozeei TS, Feizi A, Rezaeizadeh H, Zargaran A, Roohafza HR, Karimi M. The antidepressant effects of lavender (Lavandula angustifolia Mill.): A systematic review and meta-analysis of randomized controlled clinical trials. Complement Ther Med. 2021 Jun;59:102679. doi: 10.1016/j.ctim.2021.102679. Epub 2021 Feb 4.
- Su S, Wang Y, Jiang W, Zhao W, Gao R, Wu Y, Tao J, Su Y, Zhang J, Li K, Zhang Z, Zhao M, Wang Z, Luo Y, Huang X, Wang L, Wang X, Li Y, Jia Q, Wang L, Li H, Huang J, Qiu J, Xu Y. Efficacy of Artificial Intelligence-Assisted Psychotherapy in Patients With Anxiety Disorders: A Prospective, National Multicenter Randomized Controlled Trial Protocol. Front Psychiatry. 2022 Jan 20;12:799917. doi: 10.3389/fpsyt.2021.799917. eCollection 2021.
- Rappoldt LR, van der Pol MM, de Wit C, Slaghekke S, Houben C, Sondaar T, Kan KJ, van Steensel FJAB, Denys D, Vulink NCC, Utens EMWJ. Effectiveness of an innovative treatment protocol for misophonia in children and adolescents: Design of a randomized controlled trial. Contemp Clin Trials Commun. 2023 Mar 11;33:101105. doi: 10.1016/j.conctc.2023.101105. eCollection 2023 Jun.
- Jager IJ, Vulink NCC, Bergfeld IO, van Loon AJJM, Denys DAJP. Cognitive behavioral therapy for misophonia: A randomized clinical trial. Depress Anxiety. 2020 Dec 18;38(7):708-18. doi: 10.1002/da.23127. Online ahead of print.
- Cowan, E. N., Marks, D. R., & Pinto, A. Misophonia: A psychological model and proposed treatment. Journal of Obsessive-Compulsive and Related Disorders, 32, 100691. https://doi.org/10.1016/j.jocrd.2021.100691
- Jager I, de Koning P, Bost T, Denys D, Vulink N. Misophonia: Phenomenology, comorbidity and demographics in a large sample. PLoS One. 2020 Apr 15;15(4):e0231390. doi: 10.1371/journal.pone.0231390. eCollection 2020.
- Cassiello-Robbins C, Anand D, McMahon K, Brout J, Kelley L, Rosenthal MZ. A Preliminary Investigation of the Association Between Misophonia and Symptoms of Psychopathology and Personality Disorders. Front Psychol. 2021 Jan 14;11:519681. doi: 10.3389/fpsyg.2020.519681. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3-1-2024-SK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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