Effect of Music Intervention on Intravitreal Injection

Not Applicable

Completed

• Conditions: Music Intervention
• Interventions: Other: Before intravitreal injection music intervention; Other: during intravitreal injection music intervention

• Registration Number: NCT04212338
• Lead Sponsor: Afyonkarahisar Health Sciences University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-11
• Primary Completion: 2019-05-24
• Study Completion: 2019-05-24
• Status Verified: 2019-12
• Study First Submitted: 2019-12-24
• Study First Submitted QC: 2019-12-25
• Last Update Submitted: 2019-12-25
• Study First Posted: 2019-12-27
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group 1	Before intravitreal injection music intervention	Before intravitreal injection music intervention: These patients received the standard treatment and listened to music for a period of 15 minutes 30 minutes before the injection.
study group 2	during intravitreal injection music intervention	During-intravitreal injection music intervention:These patients received the standard treatment and listened to music during the injection (approximately 5 minutes).

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale for Anxiety (VAS-A)	1 day	VAS-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 Outcome Measures

Name	Time	Method
Visual Analog Scale for Pain (VAS)	1 day	VAS 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.

Trial Locations

Locations (1)

Afyonkarahisar Health Science University; 🇹🇷 Afyonkarahisar, Centre, Turkey