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Effect of Music Intervention on Intravitreal Injection

Effect of Music Intervention on Pain, Anxiety, Physiological Variables, Patient Satisfaction, and Surgeon-Patient Cooperation in Intravitreal Injection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04212338
Enrollment
219
Registered
2019-12-27
Start date
2019-03-11
Completion date
2019-05-24
Last updated
2019-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Music Intervention

Brief summary

The objective of this study was to examine the effect of music intervention in the before-intravitreal injection (IVTI) and during-IVTI periods on patients' anxiety, the sensation of pain, physiological variables, satisfaction, and surgeon-patient cooperation. The study used a randomized controlled experimental design. The study was conducted with a total of three groups: two experimental (Before-IVTI (Group1) and During-IVTI music intervention group (Group 2)) and one control group. Each of the experimental and control groups consisted of 75 patients. The patients' anxiety was evaluated using the VAS anxiety scale, pain using the VAS pain scale; surgeon-patient cooperation using the Numeric Rating Scale; and patient satisfaction with a 5-point likert-type satisfaction scale.

Interventions

OTHERBefore intravitreal injection music intervention

The patients in the Before-IVTI group listened to music for a period of 15 minutes 30 minutes before the injection.

OTHERduring intravitreal injection music intervention

The patients in the During-IVTI group listened to music during the injection (approximately 5 minutes).

Sponsors

Afyonkarahisar Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* The participants were patients aged 18 or above, * Who did not have a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had not received a diagnosis of depression, who volunteered to participate in the study, and on whom elective IVTI was carried out, or who had undergone IVTI previously.

Exclusion criteria

* The participants were patients aged under 18 years * Who had a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had received a diagnosis of depression, who did not volunteered to participate in the study, and or who had not undergone IVTI previously.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale for Anxiety (VAS-A)1 dayVAS-A is a measurement tool, in which 0 represents feeling no anxiety while 10 represents I feel extremely anxious.29 An increase in score indicates an increase in the anxiety experienced by the patient. This indicates that VAS-A is a reliable and accurate measurement tool despite its brevity. The VAS-A scale was applied to patients before, immediately after, and 15 minutes after the injection.

Secondary

MeasureTime frameDescription
Visual Analog Scale for Pain (VAS)1 dayVAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to the VAS, pain severity is rated from 0 (no pain) to 10 (the greatest imaginable pain). Any score under 3 on the scale is considered mild pain, scores between 3 and 6 are moderate pain and any score above 6 is severe pain. The VAS was applied both immediately after the injection and 15 minutes afterwards in order to determine the severity of the pain that the patients felt during the injection.

Other

MeasureTime frameDescription
Surgeon-patient cooperation1 dayNumeric Rating Scale (NRS) was used. This scale allows for a score of between 0 and 10 points.A score of 0 indicates that the patient was totally noncompliant with the surgeon's instructions and a score of 10 indicates that the patient was totally compliant. The NRS was used by the surgeon for each patient immediately after the conclusion of the injection.
Patient Satisfaction1 dayIn this study, on the basis of the review of the literature, satisfaction was evaluated using a 5-point Likert-type scale. The patients were asked to respond Very Unsatisfied, Unsatisfied, Neutral, Satisfied, or Very Satisfied. The patients' levels of satisfaction were evaluated 15 minutes after the injection.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026