Exposure to Noise or Music in Clinical Trials: A Scoping Review on Ethical and Methodological Considerations
Background: Use of noise or music in experimental human studies requires balancing the need to avoid subjecting participants to potentially harmful noise levels while still reaching levels that will produce a measurable change in the primary outcome. Several methodological and ethical aspects must b...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2024-09-01
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| Series: | Noise and Health |
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| Online Access: | https://journals.lww.com/10.4103/nah.nah_41_23 |
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| author | Eleftheria Iliadou Vasileios Bitzios Konstantinos Pastiadis Christopher J. Plack Athanasios Bibas |
| author_facet | Eleftheria Iliadou Vasileios Bitzios Konstantinos Pastiadis Christopher J. Plack Athanasios Bibas |
| author_sort | Eleftheria Iliadou |
| collection | DOAJ |
| description | Background: Use of noise or music in experimental human studies requires balancing the need to avoid subjecting participants to potentially harmful noise levels while still reaching levels that will produce a measurable change in the primary outcome. Several methodological and ethical aspects must be considered. This study aims to summarize ethical and methodological aspects, and reported outcomes, of previously published experimental paradigms using loud noise/music. Methods and materials: Four databases (Medline, Central, Web of Science, and Scopus) and two trials registries (Clinicaltrials.gov and EU Clinical Trials) were searched. Extracted items had the details of author and year of publication, study design and purpose, population, setting timeline and material, selected battery test, and effect of noise/music on participants’ hearing. Results: Thirty-four studies were included. Exposure safety considerations were reported in five studies. Eleven studies assessing hearing loss used white or narrow-band noise [(NBN (0.5–4 kHz), up to 115 dBA, duration range: 3′–24 hours)], and 10 used pop music (up to 106 dBA, duration range: 10′–4 hours). Experimental setting varied significantly. Temporary thresholds shift (TTS) and reduction in distortion product otoacoustic emissions were found at 1–8 kHz, with maximum average TTS∼21.5 dB at 4 kHz after NBN and ∼11.5 dB at 6 kHz after music exposure. All participants recovered their hearing, except for one participant in one study. In the 13 non-hearing loss studies, no hearing testing was performed after exposure, but loud noise was associated with temporary stress, bradygastria, and cardiovascular changes. Noise-induced subjective stress may be higher for participants with tinnitus. Loud noise (100 dBA, 10′) increased diastolic and mean blood pressure only in participants with hypertension. Conclusion: Experimental exposure paradigms can produce temporary changes to hearing without measurable long-term health consequences. Methodological and ethical aspects identified in this review should be considered for the development of future paradigms. |
| format | Article |
| id | doaj-art-a3a19d98efea45a085043d8f96f706a8 |
| institution | Kabale University |
| issn | 1463-1741 |
| language | English |
| publishDate | 2024-09-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Noise and Health |
| spelling | doaj-art-a3a19d98efea45a085043d8f96f706a82024-11-11T13:59:22ZengWolters Kluwer Medknow PublicationsNoise and Health1463-17412024-09-012612224325110.4103/nah.nah_41_23Exposure to Noise or Music in Clinical Trials: A Scoping Review on Ethical and Methodological ConsiderationsEleftheria IliadouVasileios BitziosKonstantinos PastiadisChristopher J. PlackAthanasios BibasBackground: Use of noise or music in experimental human studies requires balancing the need to avoid subjecting participants to potentially harmful noise levels while still reaching levels that will produce a measurable change in the primary outcome. Several methodological and ethical aspects must be considered. This study aims to summarize ethical and methodological aspects, and reported outcomes, of previously published experimental paradigms using loud noise/music. Methods and materials: Four databases (Medline, Central, Web of Science, and Scopus) and two trials registries (Clinicaltrials.gov and EU Clinical Trials) were searched. Extracted items had the details of author and year of publication, study design and purpose, population, setting timeline and material, selected battery test, and effect of noise/music on participants’ hearing. Results: Thirty-four studies were included. Exposure safety considerations were reported in five studies. Eleven studies assessing hearing loss used white or narrow-band noise [(NBN (0.5–4 kHz), up to 115 dBA, duration range: 3′–24 hours)], and 10 used pop music (up to 106 dBA, duration range: 10′–4 hours). Experimental setting varied significantly. Temporary thresholds shift (TTS) and reduction in distortion product otoacoustic emissions were found at 1–8 kHz, with maximum average TTS∼21.5 dB at 4 kHz after NBN and ∼11.5 dB at 6 kHz after music exposure. All participants recovered their hearing, except for one participant in one study. In the 13 non-hearing loss studies, no hearing testing was performed after exposure, but loud noise was associated with temporary stress, bradygastria, and cardiovascular changes. Noise-induced subjective stress may be higher for participants with tinnitus. Loud noise (100 dBA, 10′) increased diastolic and mean blood pressure only in participants with hypertension. Conclusion: Experimental exposure paradigms can produce temporary changes to hearing without measurable long-term health consequences. Methodological and ethical aspects identified in this review should be considered for the development of future paradigms.https://journals.lww.com/10.4103/nah.nah_41_23musictemporary threshold shifthearing lossnoisereview |
| spellingShingle | Eleftheria Iliadou Vasileios Bitzios Konstantinos Pastiadis Christopher J. Plack Athanasios Bibas Exposure to Noise or Music in Clinical Trials: A Scoping Review on Ethical and Methodological Considerations Noise and Health music temporary threshold shift hearing loss noise review |
| title | Exposure to Noise or Music in Clinical Trials: A Scoping Review on Ethical and Methodological Considerations |
| title_full | Exposure to Noise or Music in Clinical Trials: A Scoping Review on Ethical and Methodological Considerations |
| title_fullStr | Exposure to Noise or Music in Clinical Trials: A Scoping Review on Ethical and Methodological Considerations |
| title_full_unstemmed | Exposure to Noise or Music in Clinical Trials: A Scoping Review on Ethical and Methodological Considerations |
| title_short | Exposure to Noise or Music in Clinical Trials: A Scoping Review on Ethical and Methodological Considerations |
| title_sort | exposure to noise or music in clinical trials a scoping review on ethical and methodological considerations |
| topic | music temporary threshold shift hearing loss noise review |
| url | https://journals.lww.com/10.4103/nah.nah_41_23 |
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