Exploring the effect of music listening duration on anxiety reduction
| ISRCTN | ISRCTN47181782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47181782 |
| Secondary identifying numbers | PS130723DMS |
- Submission date
- 30/04/2024
- Registration date
- 09/05/2024
- Last edited
- 30/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Studies have shown that music can be used in various contexts to reduce anxiety. While the relationship between music and anxiety reduction has been well researched and documented, there is still a need for a controlled study on the relationship between the length of musical treatment and the reduction in anxiety to improve the self-administration of musical interventions. A recent study found that music combined with auditory beat stimulation, relative to music alone, auditory beat stimulation alone or pink noise, was effective at reducing anxiety for individuals with moderate trait anxiety (anxiety as an everyday personality trait). This study seeks to replicate and extend these findings by examining whether the strength of the findings differs depending on the length of the combined music with auditory beat stimulation.
Who can participate?
Patients aged 18 years and over with moderate trait anxiety who were actively taking anxiolytics (medications that can treat anxiety symptoms)
What does the study involve?
Participants were randomly allocated to 12, 24, or 36 minutes of either music with auditory beat stimulation (treatment) or pink noise (control). Participants completed questionnaires before and after the treatment assessing state anxiety and affect.
What are the possible benefits and risks of participating?
This study is a minimal-risk study. However, participants may have felt some discomfort in responding to the questions. To mitigate this, participants were informed that their participation was voluntary and they were able to withdraw at any time. While there were no guaranteed benefits of participating in this study, participants may have experienced a reduction in their anxiety and contributed to the understanding of the relationship between music listening and anxiety relief.
Where is the study run from?
Goldsmith's, University of London (UK)
When is the study starting and how long is it expected to run for?
December 2022 to August 2023
Who is funding the study?
1. LUCID Therapeutics, the developers of the combined music and auditory beat stimulation treatment
2. Goldsmith's, University of London (UK)
Who is the main contact?
Prof. Lauren Stewart, lauren.stewart@roehampton.ac.uk
Contact information
Public, Scientific, Principal Investigator
School of Psychology, University of Roehampton
London
SW15 4JD
United Kingdom
 ORCID ID |
0000-0002-6221-6064 |
|---|---|
| lauren.stewart@roehampton.ac.uk |
Study information
| Study design | Single-blind randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Efficacy |
| Participant information sheet | 45392_PIS.pdf |
| Scientific title | Dose-response relationship between music and anxiety reduction |
| Study acronym | DRMA |
| Study hypothesis | 1. Those assigned to the music with auditory beat stimulation (ABS) treatment condition will experience a greater reduction in anxiety relative to those in the pink noise control condition. 2. The duration of music with ABS listened to will have differential effects on anxiety symptoms. 3. Those assigned to the 36-minute music with ABS treatment condition will experience a greater reduction in anxiety than those in the 12- or 24-minute music with ABS treatment conditions. 4. The findings of the present study will replicate those of Malik and Russo (2022). |
| Ethics approval(s) |
Approved 13/07/2023, Goldsmiths, University of London Psychology Department Ethics Committee (8 Lewisham Way, London, SE14 6NW, United Kingdom; +44 (0)20 7919 7171; d.mullensiefen@gold.ac.uk), ref: PS130723DMS |
| Condition | Anxiety |
| Intervention | Participants are recruited and screened through prolific.com. In order to be eligible, participants must self-identify as taking anxiolytic medication and having moderate trait anxiety. Those eligible sign a consent form and are randomized to a condition and a dosage. The conditions are music with auditory beat stimulation (treatment condition) or pink noise (control condition). The dose variations will be listening to the audio for 12, 24, or 36 minutes. Participants will be randomized at a rate of 3:3 using the randomizer function on qualtrics.com. |
| Intervention type | Behavioural |
| Primary outcome measure | State Anxiety is measured using the State Trait Inventory for Cognitive and Somatic Anxiety at baseline and post-intervention (after 12, 24, or 36 minutes) |
| Secondary outcome measures | Affect measured using the Positive and Negative Affect Scale at baseline and post-intervention (after 12, 24, or 36 minutes) |
| Overall study start date | 14/12/2022 |
| Overall study end date | 12/08/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 120-160 |
| Total final enrolment | 144 |
| Participant inclusion criteria | 1. Currently taking anxiolytics 2. Have moderate trait anxiety as defined by previously described State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) trait anxiety threshold scores |
| Participant exclusion criteria | 1. Do not meet the criteria for moderate trait anxiety 2. Not actively taking anxiolytic medication |
| Recruitment start date | 17/07/2023 |
| Recruitment end date | 12/08/2023 |
Locations
Countries of recruitment
- Australia
- Brazil
- Canada
- Chile
- Djibouti
- England
- Ireland
- Israel
- Italy
- Malaysia
- Mexico
- Netherlands
- Northern Ireland
- Poland
- Portugal
- Romania
- Scotland
- South Africa
- Spain
- United Kingdom
- United States of America
- Wales
Study participating centre
Lewisham Way
London
SE14 6NW
United Kingdom
Sponsor information
University/education
8, Lewisham Way
London
SE14 6NW
England
United Kingdom
| Phone | +44 (0)72079197171 |
|---|---|
| HoD.Psych@gold.ac.uk | |
| Website | http://www.gold.ac.uk/ |
"ROR" |
https://ror.org/01khx4a30 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 01/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The de-identified data that supports the findings of this study will be made available on the Open Science Framework. The type of data stored: Participant responses to self-reports, including demographic information (nationality, type of medications currently taking) and raw scores on anxiety and affect questionnaires. Dates of availability: From publication date Informed consent was required and obtained for all participants. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 09/05/2024 | No | Yes |
Additional files
Editorial Notes
30/08/2024: The study contact was updated.
14/08/2024: The intention to publish date was changed from 01/08/2024 to 01/11/2024.
30/04/2024: Study's existence confirmed by the Goldsmiths, University of London Psychology Department Ethics Committee.
