Acute pain
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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