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AzTrials

PainNCT07196098

Using Gentle Music to Ease Anxiety in People Receiving Eye Treatment Injections

A study testing Slow tempo music in people with Pain and Anxiety, run by Ng Yu Siang at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial was to investigate the effects of slow tempo music on anxiety and perceived pain in patients undergoing elective intravitreal injections (IVI). The main questions it aimed to answer were: Did slow tempo music reduce the anxiety and pain of patients undergoing IVI? Did the pain threshold… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Anxiety
What is being tested?
Slow tempo music
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteMalaysia
Study dates
10 Jan 2025to 14 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients who were Malaysia citizens aged 18 and above scheduled for elective intravitreal injection of anti-vascular endothelial growth factor (VEGF),
  • capable of providing informed consent prior to trial participation.

Who cannot join

  • patients with cognitive impairment precluding informed consent,
  • patients with hearing impairment,
  • patients with underlying psychological or psychiatric disorder,
  • patients with prior salivary gland or facial surgery that could alter saliva secretion

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Daycare Center, University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

Other trials in Malaysia

About this study

Official title: Effect of Slow Tempo Music on Anxiety Markers During Intravitreal Injection: A Randomised Controlled Trial

The goal of this clinical trial was to investigate the effects of slow tempo music on anxiety and perceived pain in patients undergoing elective intravitreal injections (IVI). The main questions it aimed to answer were:

Did slow tempo music reduce the anxiety and pain of patients undergoing IVI?

Read more

Did the pain threshold differ among patients of different ethnic groups?

Participants were divided into a music intervention group and a control group. Participants in the music group listened to slow tempo music before and during IVI, while participants in the control group received IVI without background music.

The study compared salivary alpha-amylase (sAA) levels-an enzyme that correlates with anxiety level-along with blood pressure (BP) and heart rate (HR) of participants before and after IVI. At the end of the treatment, participants' pain scores were obtained.

Read the detailed description

Intravitreal injection (IVI) is a procedure in which medication is administered directly into the vitreous cavity. Since the introduction of anti-vascular endothelial growth factor (anti-VEGF) therapy two decades ago, the number of IVIs performed has increased substantially. These injections are now routinely conducted as outpatient procedures for the treatment of various retinal disorders such as diabetic macular edema (DME), age-related macular degeneration (AMD), retinal vein occlusion (RVO), polypoidal choroidal vasculopathy(PCV), and pseudophakic cystoid macular oedema.

Eligible participants were identified among patients scheduled for intravitreal injections (IVI) at the day-care surgery unit of the University of Malaya Medical Centre. Written informed consent was obtained after participants were provided with the participant information sheet and screened based on the study's inclusion and exclusion criteria. A simple random sampling method was used. After consent, each participant was randomly assigned a number using the Random Number Generator from the website https://www.calculatorsoup.com

, which generates numbers without repeats. Odd numbers were allocated to the music intervention group, and even numbers to the control group.

Data collection followed the Data Collection Proforma. Demographic information included age, gender, ethnicity, marital status, comorbid conditions, occupation, and education level. Before entering the operating room (OR), participants' baseline blood pressure (BP₀) and heart rate (HR₀) were recorded.

In this study, a standardised, copyright- and royalty-free piano composition-Andromeda (Piano Solo) by Gabriele Tosi, available for free on YouTube.com-was used. The piece was selected for its consistent tempo of 55-60 beats per minute (BPM) and stable average sound level of 60 decibels (dB). Music was played in the waiting room using a JBL Go3 speaker, with audio transmitted wirelessly via Bluetooth from a Huawei Nova 5T smartphone (Huawei, China). To maintain consistency, the speaker volume was calibrated each morning using the Sound Meter application (Google Play Store), ensuring the sound level remained at approximately 60 dB-comparable to normal conversational volume. Inside the OR, music was played directly from a computer with an attached speaker, and the same calibration method was applied. This volume level was chosen to avoid disrupting the surgeon's focus while allowing clear verbal communication between operating theatre staff and the participant. After listening to music for at least 15 minutes, participants were called into the OR according to their sequence. The same music continued to play in the OR for the music group until the end of the procedure.

Upon entering the OR, baseline samples of salivary alpha-amylase (sAA_before), BP (BP₁), and HR (HR₁) were measured. Salivary alpha-amylase (sAA) was assessed using the Cocoro Meter (Nipro Inc., Japan). Participants in the control group underwent the same procedure without background music.

All participants, regardless of group allocation, received standard IVI in accordance with clinical practice. The injections were performed under topical anaesthesia using five drops of proparacaine hydrochloride 0.5%, administered at least five minutes before the procedure. The periocular skin was cleaned with 10% povidone-iodine, while the conjunctiva and fornices were irrigated with 5% povidone-iodine and left for three minutes. The eye was then draped, and an eyelid speculum was applied. IVIs were performed under sterile conditions using a 30-gauge needle inserted 3.5-4.0 millimetres from the limbus.

During IVI, additional measurements of BP (BP₂) and HR (HR₂) were taken at the third minute. A second sAA measurement (sAA_after) was also obtained. Participants' pain levels were assessed using the Visual Analogue Scale for Pain (VAS-P).

Since approximately 30 patients were scheduled for IVI on any given day, their sequence of IVI was categorised for statistical analysis as early (8:00-10:00 a.m.), middle (10:00 a.m.-12:00 p.m.), and late (12:00-2:00 p.m.).

The duration of the procedure, type of anti-vascular endothelial growth factor (anti-VEGF) used, participant sequence, ocular diagnosis, number of prior IVIs, and history of ocular surgery were all documented. Each participant was recruited only once for the study, and no follow-up was required.

Conditions
Pain, Anxiety
Being tested
Slow tempo music
Keywords
intravitreal injection, salivary alpha amylase, music intervention, anxiety, pain
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Slow tempo musicOther

    Slow tempo music will be played 15 minutes before and during intravitreal injection.

Study groups in NCT07196098
Study groupRoleWhat they receive
Control groupNo interventionNo background music was played before and during intravitreal injections
Music GroupExperimentalSlow tempo music will be played 15 minutes before and during intravitreal injection.
Receives: Other: Slow tempo music

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary alpha amylase level

    Salivary alpha amylase level was measured in kilo units per liter (KUnits/L). It was one of the objective biomarkers to measure anxiety in this study. It was measured right before injection and the 3rd minute after injection.

    Measured: Periprocedural

  2. Blood pressure

    Blood pressure was one of the anxiety markers measured in this study. It was measured in mmHg (millimetres of mercury) using an automated sphygmomanometer that had been calibrated in accordance with the manufacturer's recommended schedule prior to the commencement of the study.

    Several measurements were taken: on arrival at the day-care centre, on arrival at the operating room, and at the third minute after the intravitreal injection.

    Measured: Periprocedural

  3. Heart rate

    Heart rate was one of the anxiety markers measured in this study. It was measured in beats per minute (bpm) using an automated sphygmomanometer that had been calibrated in accordance with the manufacturer's recommended schedule prior to the commencement of the study.

    Several measurements were taken: on arrival at the day-care centre, on arrival at the operating room, and at the third minute after the intravitreal injection.

    Measured: Periprocedural

  4. Perceived pain

    Pain score measured using visual analogue scale for pain upon completion of intravitreal injection.

    It is presented as a 100 mm horizontal line, with numerical values ranging from 0 (no pain) to 10 (worst imaginable pain) distributed evenly along the line. Patients are instructed to indicate their current pain level by marking a point on the scale that best represents their experience. This scale is adapted from the Ministry of Health Malaysia's pain assessment guidelines and is routinely utilised in clinical settings in the country.

    Measured: Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start10 Jan 2025
  3. Primary completion28 Mar 2025
  4. Study completion14 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A repeated-measures, randomised controlled trial
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07196098
Sponsor's protocol ID
202424-13359
Status last verified
Sep 2025
First submitted
25 Aug 2025
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: to protect the confidentiality of the data of study participants

Publications

  • Sugimoto K, Kanai A, Shoji N. The effectiveness of the Uchida-Kraepelin test for psychological stress: an analysis of plasma and salivary stress substances. Biopsychosoc Med. 2009 Apr 3;3:5. doi: 10.1186/1751-0759-3-5.

    PubMed 19341484
  • Chatterton RT Jr, Vogelsong KM, Lu YC, Ellman AB, Hudgens GA. Salivary alpha-amylase as a measure of endogenous adrenergic activity. Clin Physiol. 1996 Jul;16(4):433-48. doi: 10.1111/j.1475-097x.1996.tb00731.x.

    PubMed 8842578
  • Takai N, Yamaguchi M, Aragaki T, Eto K, Uchihashi K, Nishikawa Y. Effect of psychological stress on the salivary cortisol and amylase levels in healthy young adults. Arch Oral Biol. 2004 Dec;49(12):963-8. doi: 10.1016/j.archoralbio.2004.06.007.

    PubMed 15485637
  • Iizuka N, Awano S, Ansai T. Salivary alpha-amylase activity and stress in Japan air self-defense force cargo pilots involved in Iraq reconstruction. Am J Hum Biol. 2012 Jul-Aug;24(4):468-72. doi: 10.1002/ajhb.22247. Epub 2012 Feb 18.

    PubMed 22344628
  • Noto Y, Sato T, Kudo M, Kurata K, Hirota K. The relationship between salivary biomarkers and state-trait anxiety inventory score under mental arithmetic stress: a pilot study. Anesth Analg. 2005 Dec;101(6):1873-1876. doi: 10.1213/01.ANE.0000184196.60838.8D.

    PubMed 16301277
  • Anderson LC, Garrett JR, Johnson DA, Kauffman DL, Keller PJ, Thulin A. Influence of circulating catecholamines on protein secretion into rat parotid saliva during parasympathetic stimulation. J Physiol. 1984 Jul;352:163-71. doi: 10.1113/jphysiol.1984.sp015284.

    PubMed 6205147
  • Skov Olsen P, Kirkegaard P, Rasmussen T, Magid E, Poulsen SS, Nexo E. Adrenergic effects on secretion of amylase from the rat salivary glands. Digestion. 1988;41(1):34-8. doi: 10.1159/000199729.

    PubMed 2462520
  • Batzri S, Selinger Z. Enzyme secretion mediated by the epinephrine -receptor in rat parotid slices. Factors governing efficiency of the process. J Biol Chem. 1973 Jan 10;248(1):356-60. No abstract available.

    PubMed 4348211
  • Bellocchio L, Soria-Gomez E, Quarta C, Metna-Laurent M, Cardinal P, Binder E, Cannich A, Delamarre A, Haring M, Martin-Fontecha M, Vega D, Leste-Lasserre T, Bartsch D, Monory K, Lutz B, Chaouloff F, Pagotto U, Guzman M, Cota D, Marsicano G. Activation of the sympathetic nervous system mediates hypophagic and anxiety-like effects of CB(1) receptor blockade. Proc Natl Acad Sci U S A. 2013 Mar 19;110(12):4786-91. doi: 10.1073/pnas.1218573110. Epub 2013 Mar 4.

    PubMed 23487769
  • Hız M, Ciğerci Y, Doğan M. The effects of the music intervention on anxiety, pain, vital signs, and patient satisfaction in intravitreal injection: a randomized controlled study. Anatolian Clinic the Journal of Medical Sciences. 2022;27(2):150-61.

  • Chan JC, Chan LP, Yeung CP, Tang TW, O YM, Lam WC. Effect of Music on Patient Experience during Intravitreal Injection. J Ophthalmol. 2020 Jul 30;2020:9120235. doi: 10.1155/2020/9120235. eCollection 2020.

    PubMed 32802492
  • Brosh K, Roditi E, Wasser LM, Aryan A, Hanhart J, Potter MJ. Effect of Music Selection on Anxiety Level during Intravitreal Injections for Individuals of Varying Cultures. Ophthalmic Epidemiol. 2022 Oct;29(5):582-587. doi: 10.1080/09286586.2021.1955390. Epub 2021 Jul 22.

    PubMed 34293998
  • Chen X, Seth RK, Rao VS, Huang JJ, Adelman RA. Effects of music therapy on intravitreal injections: a randomized clinical trial. J Ocul Pharmacol Ther. 2012 Aug;28(4):414-9. doi: 10.1089/jop.2011.0257. Epub 2012 Apr 16.

    PubMed 22506884
  • Richard-Lalonde M, Gelinas C, Boitor M, Gosselin E, Feeley N, Cossette S, Chlan LL. The Effect of Music on Pain in the Adult Intensive Care Unit: A Systematic Review of Randomized Controlled Trials. J Pain Symptom Manage. 2020 Jun;59(6):1304-1319.e6. doi: 10.1016/j.jpainsymman.2019.12.359. Epub 2019 Dec 24.

    PubMed 31881291
  • Beasley R. Pre-procedural education on anxiety levels during intravitreal injections. International Journal of Ophthalmic Practice. 2011;2(1):20-7.

Questions about this trial

What is this clinical trial studying?

A study testing Slow tempo music in people with Pain and Anxiety, run by Ng Yu Siang at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary alpha amylase level (time frame: Periprocedural). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07196098, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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