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Active, not recruitingNCT06914830Updated Apr 6, 2025

The Effect of Musical Video With Virtual Reality Goggles on Patient's Anxiety and Comfort During Ureteroscopy

An interventional study of Musical video demonstration with virtual reality glasses in Ureteroscopy, Operation Time and Music Listening, sponsored by Aydin Adnan Menderes University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jun 2024, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
Male
01

Study summary

The effect of musical video with virtual reality goggles on patient's anxiety and comfort during ureteroscopy

Read the detailed description

Ureteroscopy is a surgical procedure used diagnostically or therapeutically in urology. Eliminating the patient's fear, anxiety and worry in the preoperative period is necessary to reduce the surgical stress response seen during the surgical procedure and to ensure normal physiological functions after surgery, early mobilization and patient comfort. When the patient is taken into surgery, reassuring and gentle communication should be established to reduce the patient's anxiety. For this reason, it is important that the surgical team members feel that they are with the patient and make the patient feel that they are with them.

Music is an art that organizes sounds in a way that provides a feeling of happiness. It can help the patient cope with all aspects of the disease; it improves physical, emotional, social and spiritual well-being and can help control and reduce pain and/or agitation. studies examining the relationship between music and depression and anxiety, it was found that depression and anxiety scores were significantly lower in the music therapy group compared to the control group.

The aim of this study was to examine the effect of virtual reality goggles and musical video playback on the patient's operating room anxiety and comfort during ureteroscopy.

The hypotheses that there is no difference in anxiety and comfort levels in the intervention and control groups after music intervention will be tested.

02

Conditions studied

  • Ureteroscopy
  • Operation Time
  • Music Listening

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Keywords

  • Ureteroscopy
  • music therapy
  • virtual reality
  • anxiety
  • comfort
03

In context

Anxiety Disorders

5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's planned enrollment of 46 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 240 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being able to speak and understand Turkish
  • Being open to communication
  • Being literate
  • Being over 18 years of age
  • Having a Glasgow Coma Scale score of 13 and above

Exclusion criteria

Exclusion Criteria:

  • Visual and hearing impairment
  • Previous surgery
  • Being a healthcare personnel
  • General anesthesia of the patient
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Experimental group

    The study group was shown the musical video created by the researchers by taking expert opinions during the surgery.

    Other: Musical video demonstration with virtual reality glasses

  • No intervention
    Control group

    The control group continued to receive the routine care

Interventions

  • OtherMusical video demonstration with virtual reality glasses

    The research was explained to the patient before the operation. The patient was started to watch a video with music with virtual glasses at the 5th minute of the operation and watched it throughout the operation. Two hours after the surgery, the patient who underwent ureteroscopy completed the Data Collection Form, Surgery Specific Anxiety Scale and Perianesthesia Comfort Scale.

06

What researchers measure

Primary outcomes

  1. Determination of the patient's anxiety levels after the intervention

    The Surgery-Specific Anxiety Scale is a five Likert-type scale assessing of anxiety. The reference range of the scale is 0-50, with a higher score reflecting fear of pain, fear of dying during surgery, and fear of postoperative complications and limitations. Cronbach's alpha value of the scale is 0.79.

    Time frame: two hours after surgery

  2. Determination of the patient's comfort levels after the intervention

    The Perianesthesia Comfort Scale is based on a theoretical framework of three levels and four dimensions. It evaluates comfort needs and the achievement of expected comfort improvements. Scale scoring is 24-144 (min-max). Cronbach's alpha: 0.83. A low score indicates poor comfort and a high score indicates good comfort.

    Time frame: two hours after surgery

07

Study locations

1 site
  • Aydın Adnan Menderes University
    Efeler, Aydın 09090, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Supporting information: Clinical study report

Time frame: 6 months after publication

Access criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06914830
Responsible party
Hilal Hatice Ülkü (Ass.Prof., Aydin Adnan Menderes University) — Principal investigator
First posted
Apr 6, 2025
Start date
Jun 10, 2024
Primary completion
Dec 10, 2024
Completion
May 10, 2025 (estimated)
Last update
Apr 6, 2025

Study contacts

Hilal Hatice ÜLKÜ, PhD
study chair · Aydin Adnan Menderes University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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