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

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.

Study Overview

• Status: Completed
• Conditions: Music Intervention
• Intervention / Treatment: Other: Before intravitreal injection music intervention; Other: during intravitreal injection music intervention

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Centre
    • Afyonkarahisar, Centre, Turkey, 03200
      • Afyonkarahisar Health Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group 1; 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.	Other: Before 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.
Experimental: study group 2; During-intravitreal injection music intervention:These patients received the standard treatment and listened to music during the injection (approximately 5 minutes).	Other: during intravitreal injection music intervention; The patients in the During-IVTI group listened to music during the injection (approximately 5 minutes).
No Intervention: control group; The music intervention was not conducted with the patients in the control group. These patients received the standard treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for Anxiety (VAS-A)	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for Pain (VAS)	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.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon-patient cooperation	Numeric 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.	1 day
Patient Satisfaction	In 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.	1 day

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University
• Investigators: Principal Investigator: Yeliz Ciğerci, +90 272 444 0304

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): May 24, 2019
• Study Completion (Actual): May 24, 2019

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 27, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 25, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019/76

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No