Trials / Completed
CompletedNCT05441891
Effect of Modulated Auditory Stimulation on Interaural Auditory Perception
Effect of an Equalizer-modulated Auditory Intervention on the Asymmetry of Interaural Auditory Perception in Groups of Different Emotional States
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 233 (actual)
- Sponsor
- University of Alcala · Academic / Other
- Sex
- All
- Age
- 31 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This study analyzes the effect of an equalizer-modulated auditory intervention on the asymmetry of interaural auditory perception in groups with different emotional states such as well-being, anxiety, depression and mixed anxiety-depression.
Detailed description
The present study follows a randomized, double-blind (investigator and outcome assessor), parallel and controlled design. The auditory intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). Participants assigned to the control group are cited to the Health centre, but they do not received any intervention. These subjects follow the same evaluation and data collection process. Once randomized, all participants will make a first control visit in which a pure-tone audiometry was carry out and completed the various psychiatric evaluation tests to classify into different groups: Goldberg Anxiety and Depression Scale (GADS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), and Sociodemographic variables (age, gender, nationality, education, working status, noise exposure, use of ear protection, and present or past use of any analgesic, anxiolytic or antidepressant for longer than a week). The study variables collected at 3 months were pure-tone audiometry (air conduction).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Auditory intervention filter-modulated group | Intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). The musical intervention was always performed with the same songs and in the same order using original CDs, heard through headphones (Beyerdynamic, DT 250 / 80 ohm. GMBH \& Co. KG, Theresienstr. 8 D-74072 Heilbronn, Germany). The music was played with a sound system (Panasonic MASH, No. SA-PM24. Hamburg, Germany). and filtered through an equalizer called Earducator (Hollagen Designs, PÍO. Box 43 7864 Bergvliet W.Cape - South Africa) that modulates music by alternating low and high tones with an unpredictable cadence, preventing habituation. It also allows very narrow band complementary filters to attenuate (by about 40 dB) abnormally perceived frequencies (hyper-hearing peaks): filters in: 1 kHz - 1,5 kHz - 2kHz - 3 kHz - 4 kHz - 8kHz. |
Timeline
- Start date
- 2022-06-17
- Primary completion
- 2022-10-19
- Completion
- 2022-10-21
- First posted
- 2022-07-01
- Last updated
- 2022-11-02
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05441891. Inclusion in this directory is not an endorsement.