UreteroscopyNCT06914830
The Effect of Musical Video With Virtual Reality Goggles on Patient's Anxiety and Comfort During Ureteroscopy
A study testing Musical video demonstration with virtual reality glasses in people with Ureteroscopy and Operation Time, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The effect of musical video with virtual reality goggles on patient's anxiety and comfort during ureteroscopy Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Ureteroscopy, Operation Time, Music Listening
- What is being tested?
- Musical video demonstration with virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 10 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Visual and hearing impairment
- Previous surgery
- Being a healthcare personnel
- General anesthesia of the patient
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University
Efeler, Aydın, 09090
About this study
Official title: 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
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.
- Conditions
- Ureteroscopy, Operation Time, Music Listening
- Being tested
- Musical video demonstration with virtual reality glasses
- Keywords
- Ureteroscopy, music therapy, virtual reality, anxiety, comfort
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical video demonstration with virtual reality glassesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The study group was shown the musical video created by the researchers by taking expert opinions during the surgery. Receives: Other: Musical video demonstration with virtual reality glasses |
| Control group | No intervention | The control group continued to receive the routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two hours after surgery
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.
Measured: two hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start10 Jun 2024
- Primary completion10 Dec 2024
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UreteroscopyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Following recruitment, patients were divided into study and control groups by randomization (1:1 randomization)
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Hatice Ülkü, Aydin Adnan Menderes University
- Investigators
- Hilal Hatice ÜLKÜ, PhD, Study chair, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914830
- Sponsor's protocol ID
- musical video show
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musical Video With Virtual Reality Goggles: Effects on Anxiety and Comfort in Ureteroscopic Surgery
- ClinicalTrials.gov ID
- NCT06914830
- Acronym / sponsor ID
- musical video show
- Conditions
- Ureteroscopy, Operation Time, Music Listening
- Keywords
- Ureteroscopy, music therapy, virtual reality, anxiety, comfort
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of musical video with virtual reality goggles on patient's anxiety and comfort during ureteroscopy
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following recruitment, patients were divided into study and control groups by randomization (1:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Musical video demonstration with virtual reality glassesThe study group was shown the musical video created by the researchers by taking expert opinions during the surgery. |
| Control group | No intervention | –The control group continued to receive the routine care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Visual and hearing impairment
- Previous surgery
- Being a healthcare personnel
- General anesthesia of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musical video demonstration with virtual reality glassesThe 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. | Other | Experimental group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Hatice ÜLKÜ, PhD study chair
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musical video demonstration with virtual reality glasses in people with Ureteroscopy and Operation Time, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the patient's anxiety levels after the intervention (time frame: two hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.