- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06914830
The Effect of Musical Video With Virtual Reality Goggles on Patient's Anxiety and Comfort During Ureteroscopy
Musical Video With Virtual Reality Goggles: Effects on Anxiety and Comfort in Ureteroscopic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aydın
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Efeler, Aydın, Turkey, 09090
- Aydın Adnan Menderes University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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No Intervention: Control group
The control group continued to receive the routine care
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Experimental: Experimental group
The study group was shown the musical video created by the researchers by taking expert opinions during the surgery.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Determination of the patient's anxiety levels after the intervention
Time Frame: two hours after surgery
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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.
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two hours after surgery
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Determination of the patient's comfort levels after the intervention
Time Frame: two hours after surgery
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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.
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two hours after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hilal Hatice ÜLKÜ, PhD, Aydin Adnan Menderes University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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