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Completed

NCT Number: NCT04212338

Effect of Music Intervention on 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.

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Key information

Conditions

Music Intervention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Science University

Afyonkarahisar, Centre, 03200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

during intravitreal injection music intervention

Other

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

Primary outcomes

  1. Visual Analog Scale for Anxiety (VAS-A)

    Time frame: 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 outcomes

  1. Visual Analog Scale for Pain (VAS)

    Time frame: 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.

Other outcomes

  1. Surgeon-patient cooperation

    Time frame: 1 day

    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.

  2. Patient Satisfaction

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 27, 2019
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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