Effect of Music Intervention on Intravitreal Injection

NCT ID: NCT04212338

Last Updated: 2019-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-11

Study Completion Date

2019-05-24

Brief Summary

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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

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Conditions

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Music Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Before intravitreal injection music intervention

Intervention Type OTHER

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

study group 2

During-intravitreal injection music intervention:These patients received the standard treatment and listened to music during the injection (approximately 5 minutes).

Group Type EXPERIMENTAL

during intravitreal injection music intervention

Intervention Type OTHER

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

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

during intravitreal injection music intervention

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Afyonkarahisar Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Yeliz Ciğerci

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yeliz Ciğerci

Role: PRINCIPAL_INVESTIGATOR

+90 272 444 0304

Locations

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Afyonkarahisar Health Science University

Afyonkarahisar, Centre, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019/76

Identifier Type: -

Identifier Source: org_study_id