Effect of Virtual Reality and Stress Ball Interventions on Procedure-Related Fear, Pain, Anxiety, and Patient Satisfaction in Patients Undergoing Ureterorenoscopy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aimed to determine the effects of virtual reality and stress ball interventions on procedure-related fear, anxiety, and patient satisfaction in patients undergoing ureterorenoscopy. The study is a prospective, randomized controlled clinical trial. The sample size was calculated to ensure sufficient statistical power to detect an effect size of Cohen's f = 0.333, considering α = 0.05, power (1-β) = 0.80, and number of groups = 3, resulting in 30 participants per group, for a total of 90 patients undergoing ureterorenoscopy. Data will be collected using the Demographic Information Form, State Anxiety Inventory, Procedure-Related Fear Scale, Visual Analog Scale, and Newcastle Satisfaction with Nursing Care Scale. Upon admission to the clinic for the procedure, all patients will complete the Demographic Information Form, State Anxiety Inventory, and Procedure-Related Fear Scale prior to the surgical intervention. Patients in the virtual reality group will view nature scenes with relaxing music via a virtual reality headset in the clinic, with the sound level adjusted according to the patient's preference. Patients in the stress ball group will be instructed to squeeze the ball up to five counts every three counts. The control group will receive the routine pre-procedure procedures and standard care in the clinic. After the procedure, when patients return to the clinic (and are in bed), the State Anxiety Inventory, Visual Analog Scale, and Newcastle Satisfaction with Nursing Care Scale will be administered. Data analysis will include descriptive statistics and appropriate parametric or non-parametric tests (t-test, Mann-Whitney U, Kruskal-Wallis). A p-value of \<0.05 will be considered statistically significant in comparisons.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• • Aged 18 years or older,

‣ Scheduled for ureteroscopy (URS),

⁃ Fully conscious, oriented, and cooperative,

⁃ Provided written informed consent to participate in the study,

⁃ Able to speak and understand Turkish,

⁃ Without visual or hearing impairments,

⁃ No prior experience with virtual reality (VR),

⁃ Without any mental health disorders.

Locations
Other Locations
Turkey
Tarsus University
RECRUITING
Mersin
Contact Information
Primary
Gamze Bozkul
gamze.bozkul@gmail.com
+903246000033
Backup
Yurdagül Günaydın
yurdagulgunaydin@tarsus.edu.tr
Time Frame
Start Date: 2026-02-02
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 90
Treatments
Experimental: Virtual reality group
Patients in the virtual reality (VR) study group will watch videos in the clinic using a virtual reality headset. Patients will be asked to lie in a supine position and wear a VR headset (Shinecon SC-G04E Virtual Reality Headset) compatible with Android smartphones, equipped with headphones that minimize sound loss. Through the VR headset, patients will be shown nature scenes with a relaxing music background, which can be adjusted to the patient's preferred volume. After each use, the VR headset will be disinfected according to the usage instructions.
Experimental: Stress Ball Group
The stress ball group, patients were instructed on how to use the stress ball. After receiving the stress ball, they were asked to squeeze it up to five times every three counts. Patients were advised to continue using the stress ball until they left the clinic. Each stress ball was assigned to a single patient and not shared.
No_intervention: Control group
In the control group, the routine pre-procedure procedures and standard clinical practices will be applied
Related Therapeutic Areas
Sponsors
Leads: Tarsus University

This content was sourced from clinicaltrials.gov