ISRCTN ISRCTN10133544
DOI https://doi.org/10.1186/ISRCTN10133544
Sponsor OzMian Ltd
Funders OzMian Ltd, Investigator initiated and funded
Submission date
26/07/2026
Registration date
27/07/2026
Last edited
27/07/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Participant Information Sheet
The Effects of Sound on Immune Cell Responsiveness
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Why is this study being conducted?
Sound and music are widely used in everyday life and are known to influence how people feel, yet their immediate effects on immune cell function are not well understood. This research study is being conducted to explore whether brief exposure to sound produces measurable, short-term changes in immune cell responsiveness.
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Purpose of the Study
This is a research study. It is not a diagnostic study, and nothing in this study is intended to diagnose disease, assess health status, or replace medical tests or clinical advice. The study examines whether brief exposure to sound produces immediate, short-term changes in immune cell responsiveness, as measured from a finger-prick blood sample using Leukocyte Coping Capacity (LCC).


The procedure involves taking finger-prick blood samples before and after listening to two distinct sound samples. A total of four fingertip blood samples will be taken during the session. Any chemicals used are added only to the isolated blood sample during analysis. No chemicals come into contact with your body. Samples are analysed immediately and are not stored.


This technique has been used extensively in peer-reviewed scientific publications and is regarded as a low-risk research procedure. Some sounds may be unfamiliar, unconventional, or structurally altered, and may not resemble music in the usual sense. Your experience of the sound, whatever it may be, is an important part of the research.
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What Will Happen?
You will be asked to sit quietly and complete some questionnaires. Please do not use your mobile phone during the session. You will listen to two five-minute sound or music samples, or silence. The order of the sounds is randomised.


A fingertip blood sample will be taken at several points during the session, resulting in a total of four fingertip samples. All samples are analysed immediately and are not stored.
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What Will I Gain From Taking Part?
Participants often find it interesting and engaging to reflect on how they respond to different sounds. If you choose to receive feedback, you may learn how your immune cells responded during the session.


Your participation contributes to research exploring the relationship between sound, human experience, and immune function.
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Risks
You may experience brief discomfort during the finger-prick, similar to that used for checking blood glucose. The procedure is regarded as low risk. There is a very small possibility of infection. This risk is minimised through established procedures, including the use of alcohol wipes and single-use, sterile, disposable lancets. You may stop the study at any time if you feel uncomfortable.
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Use of Results
The results from this study may be used in a scientific publication or presentation. You will not be identified individually in any publication or report. All results will be anonymised before analysis and collated at group level only. The results will be used to describe the findings of the study.


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Voluntary Participation and Confidentiality
Participation is entirely voluntary. You may withdraw at any time without giving a reason. All information will be kept confidential. You will not be identifiable from any published material.


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Chief Investigator
Dr Rubina Mian
Contact email: rubina@ozmian.com
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Participant Details
Full Name: _______________________________________________
Date of Birth (DD/MM/YYYY): _______________________________
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Employment or Study Status
(please complete one section)
If employed or self-employed
Job title / role: _________________________________
Organisation (if applicable): _____________________
Main role / type of work: _________________________
If a student
Course / subject: _________________________________
Year of study: ____________________________________
Institution: _____________________________________
If not currently employed or studying
(you may leave this section blank or add any detail you wish):
___________________________________________________
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General Health Questionnaire


1. Have you had any coughs, colds, or flu-like symptoms in the last two weeks?
☐ Yes ☐ No
If yes, please specify: _________________________________


2. Do you suffer from any allergies?
☐ Yes ☐ No
If yes, please specify: _________________________________


3. Do you have any long-term conditions that affect immune function


(for example autoimmune conditions, diabetes, or chronic inflammatory conditions)?
☐ Yes ☐ No
If yes, please specify: _________________________________


4. Are you currently taking any medication that may affect immune function
(for example steroids, immunosuppressants, or biologic therapies)?
☐ Yes ☐ No
If yes, please specify: _________________________________


5. Are you taking any blood-thinning or antiplatelet medication


(for example warfarin, apixaban, rivaroxaban, clopidogrel, or regular aspirin)?
☐ Yes ☐ No
If yes, please specify: _________________________________


6. Have you ever fainted or felt dizzy during blood tests or finger-prick sampling?
☐ Yes ☐ No
If yes, please specify: _________________________________


7. Do you currently have broken skin, infection, or wounds on your fingertips?
☐ Yes ☐ No
8. Have you noticed any changes in your hearing or sensitivity to sound?
☐ Yes ☐ No
If yes, please specify: _________________________________


9. Do you have any diagnosed hearing conditions
(for example tinnitus, hearing loss, or hyperacusis)?
☐ Yes ☐ No
If yes, please specify: _________________________________


10. Have you experienced discomfort, distress, or strong unease in response to certain sounds or music in the past?
☐ Yes ☐ No
If yes, please specify: _________________________________


11. Have you consumed alcohol in the last 24 hours?
☐ Yes ☐ No


12. Have you undertaken strenuous exercise in the last 24 hours
(for example running, gym training, or competitive sport)?
☐ Yes ☐ No
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Consent
I confirm that I have read and understood the information above and agree to take part in this research study.


Participant Signature: ___________________________ Date: __________
I confirm that the participant has had the opportunity to ask questions, that eligibility has been assessed, and that informed consent has been obtained prior to the start of the study.


Chief Investigator Signature: _____________________ Date: __________
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Feedback Preference
☐ I do not wish to receive feedback
☐ I would like to receive feedback on how my immune cells responded
☐ I would like to receive a summary of the pooled, anonymised study results
Email (if feedback requested): ______

Contact information

Dr Rubina Mian
Public, Scientific, Principal investigator

OzMian Ltd
C/O Langard Lifford Hall
Lifford Lane
Kings Norton
Birmingham
B30 3JN
United Kingdom

Phone +44 7710619790
Email rubina@ozmian.com

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlPlacebo
AssignmentCrossover
PurposeBasic science
Scientific titleEffect of listening to music compared with no audio on leukocyte coping capacity in adults: an exploratory randomised two-period crossover study
Study objectives To determine whether brief exposure to a defined music recording is associated with a greater within-participant change in leukocyte coping capacity (LCC) than a time-matched no-audio condition.
Ethics approval(s)

Approved 05/05/2025, The Independent Ethics Committee (OzMian Ltd, C/O Langard Lifford, OzMian Limited, Lifford Hall, Lifford Lane, Kings Norton, Birmingham, B30 3JN, United Kingdom; +44 7710619790; info@ozmian.com), ref: Music OzMian Ref April 2025-1M

Health condition(s) or problem(s) studiedLeukocyte function in healthy adults
InterventionParticipants completed both conditions during a single study session in a randomised two-period crossover design.

During the music condition, participants listened to music or no audio. They were unaware of the music or length of the 5-minute 28-second studio recording of Peter Gabriel’s “In Your Eyes” from the 2012 remastered edition of So. The uncompressed WAV recording was played from an iPad Pro through a PreSonus HP4 headphone amplifier and Beyerdynamic DT 700 PRO X headphones at approximately 73 dB.

During the time-matched no-audio control condition, participants wore the same headphones for the same duration with no audio playing. A 15-minute washout and settling interval separated the two conditions.

Capillary fingertip blood samples were collected immediately before and after each condition to measure leukocyte coping capacity (LCC).

Immediately before the participants entered the room, a session-level binary random number was generated in Microsoft Excel using RANDBETWEEN(0,1), assigning either music followed by no audio or no audio followed by music. Participants attended in sessions of one or three, and participants within the same session followed the same assigned sequence. There was no subsequent follow-up.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Leukocyte coping capacity (LCC) measured using capillary fingertip blood using the LCC chemiluminescence assay and reported in relative light units (RLU) at pre- and post-condition
Key secondary outcome measure(s)
Completion date16/07/2026

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit120 Years
SexAll
Target sample size at registration30
Total final enrolment28
Key inclusion criteria1. Adults aged 18 years or older
2. Able to understand the study information and provide informed consent
3. Willing to undergo capillary fingertip blood sampling and complete both the music and no-audio listening conditions
Key exclusion criteria1. Known medical condition causing immunosuppression
2. Current use of immunosuppressive medication
Date of first enrolment06/02/2026
Date of final enrolment16/07/2026

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centres

Hyatt Centric Cambridge
37 Eddington Avenue
Cambridge
CB3 1SE
England
Methodist Church
Castle Street Methodist Church
Castle Street
Cambridge
CB3 0AH
England

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing planAnonymised individual participant data relevant to the reported findings, including leukocyte coping capacity measurements and selected experiential responses, may be included in the peer-reviewed results publication and/or its supplementary materials. All participants provided written consent for the publication and sharing of anonymised individual-level and group-level data. Names, contact details and other direct identifiers will not be published. Free-text responses will be paraphrased or generalised where necessary to minimise the risk of indirect identification. No identifiable data will be shared, and all reporting will remain within the scope of the participant consent and ethics approval.

Editorial Notes

27/07/2026: Trial's existence confirmed by The Independent Ethics Committee.