Effect of Music Intervention on Intravitreal Injection

Music Intervention Clinical Trial

Official title:

Effect of Music Intervention on Pain, Anxiety, Physiological Variables, Patient Satisfaction, and Surgeon-Patient Cooperation in Intravitreal Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212338
• Other study ID #: 2019/76
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: May 24, 2019

Study information

• Verified date: December 2019
• Source: Afyonkarahisar University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Music Intervention

Intervention

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

Locations

Country	Name	City	State
Turkey	Afyonkarahisar Health Science University	Afyonkarahisar	Centre

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar University of Health Sciences

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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