Effect of Music Intervention on Intravitreal Injection

NCT04212338 | Completed

• 1 other identifier: 2019/76
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Music Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analog Scale for Pain (VAS)

  1 day

Other Outcomes (2)

• Surgeon-patient cooperation

  1 day

• Patient Satisfaction

  1 day

Study Arms (3)

study group 1

EXPERIMENTAL

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

study group 2

EXPERIMENTAL

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

control group

NO INTERVENTION

The music intervention was not conducted with the patients in the control group. These patients received the standard treatment.

Interventions

Before intravitreal injection music intervention OTHER

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

study group 1

during intravitreal injection music intervention OTHER

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

study group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, Centre, 03200, Turkey (Türkiye)

Location

Study Officials

• Yeliz Ciğerci

  +90 272 444 0304

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: December 27, 2019
• Study Start: March 11, 2019
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-12

Locations

TU (1)