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

NCT07196098 | Completed

• 1 other identifier: 202424-13359
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pain; Anxiety

Keywords

intravitreal injection; salivary alpha amylase; music intervention; anxiety; pain

Outcome Measures

Primary Outcomes (4)

• 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.

  Periprocedural

• 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.

  Periprocedural

• 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.

  Periprocedural

• 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.

  Periprocedural

Study Arms (2)

Control group

NO INTERVENTION

No background music was played before and during intravitreal injections

Music Group

EXPERIMENTAL

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

Other: Slow tempo music

Interventions

Slow tempo music OTHER

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

Music Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ng Yu Siang: lead

Study Sites (1)

Daycare Center, University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (18)

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  PMID: 23487769 BACKGROUND

• 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.

  BACKGROUND

• 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.

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

  BACKGROUND

• Jeong K, Kim J, Kim J, Hwang J. Relationship between Pain and Injection Site during Intravitreal Injection. Journal of the Korean Ophthalmological Society. 2016;57:930.

  BACKGROUND

• Segal O, Segal-Trivitz Y, Nemet AY, Cohen P, Geffen N, Mimouni M. Anxiety levels and perceived pain intensity during intravitreal injections. Acta Ophthalmol. 2016 Mar;94(2):203-4. doi: 10.1111/aos.12802. Epub 2015 Jul 28. No abstract available.

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MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Ng Yu Siang Doctor

  Universiti Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: A repeated-measures, randomised controlled trial

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 29, 2025
• Study Start: January 10, 2025
• Primary Completion: March 28, 2025
• Study Completion: August 14, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)