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

April 3, 2025 updated by: Hilal Hatice Ülkü, Aydin Adnan Menderes University

Musical Video With Virtual Reality Goggles: Effects on Anxiety and Comfort in Ureteroscopic Surgery

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

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Aydın
      • Efeler, Aydın, Turkey, 09090
        • Aydın Adnan Menderes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group continued to receive the routine care
Experimental: Experimental group
The study group was shown the musical video created by the researchers by taking expert opinions during the surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the patient's anxiety levels after the intervention
Time Frame: two hours after surgery
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.
two hours after surgery
Determination of the patient's comfort levels after the intervention
Time Frame: two hours after surgery
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.
two hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Hilal Hatice ÜLKÜ, PhD, Aydin Adnan Menderes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Actual)

December 10, 2024

Study Completion (Estimated)

May 10, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • musical video show

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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