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

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Musical 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aydin Adnan Menderes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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