Skip to content

Music during INJECTION in the eye

Music in the relief of pain and anxiety during Intraviteral Injection: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5r5cn8j
Enrollment
Unknown
Registered
2021-10-26
Start date
2021-08-02
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Acute pain

Interventions

The study will consist of two groups: a control (CG) and an experimental (EG) and will have an allocation ratio of 1:1. Music will be offered before (about 5 minutes) and during (about 1 minute) the e

Sponsors

Universidade Federal de Sergipe
Lead Sponsor
Hospital de Olhos de Sergipe
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Be 18 years of age or older; need one or more consecutive IVI applications for any of these conditions: diabetic macular edema, age-related macular degeneration, or central retinal vein occlusion.

Exclusion criteria

Exclusion criteria: Patients who have already undergone procedures and/or ophthalmic surgery; patients who have chronic pain and make continuous use of pain management medications (NSAIDs, opioids and adjuvant medications); patients who have some type of hearing impairment; patients who report that they do not like listening to music or that it brings negative feelings and memories; patients who have neurological diseases or who are unable to understand the guidelines for measuring pain.

Design outcomes

Primary

MeasureTime frame
Assess the pain. The numerical verbal scale (NVS) will be used, in which the collector will ask the participant the intensity of pain through a numerical classification from zero to ten (zero – no pain and ten – maximum pain). We will see if music reduces pain during intravitreal injection;Assess anxiety. The State-Trait Anxiety Inventory will be used, which consists of twenty items, with scores ranging from one (almost never) to four (almost always). To quantify the answers, pay attention to the positive questions (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) that receive an inverted score to the answer and to the negative questions (3, 4, 6, 7, 9, 12, 13, 14, 17, 18), which receive a score corresponds to the answer. We will see if music reduces anxiety during intravitreal injection

Secondary

MeasureTime frame
Assessing pain catastrophizing. The Pain Catastrophizing Scale (PCS) will be used. It consists of 13 items, which are divided into 3 subgroups: helplessness (items 1,2,3,4,5,12), expansion (items 6,7,13) and rumination (items 8,9,10,11 ), in which the patient will give a value from zero (never) to four (always). Scores range from 0 to 52 and the final score is the sum of all items. We will see if the pain after the intravitreal injection lasts for a long period

Countries

Brazil

Contacts

Public ContactMoniery Santos
monierysilva@gmail.com+55(79)999516703

Outcome results

None listed

Source: REBEC (via WHO ICTRP)