NCT07265960

Effects of Virtual Reality and Stress Ball on Fear, Pain, Anxiety, and Satisfaction in Ureterorenoscopy Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tarsus University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The data will be analyzed using computer software. Patients' descriptive characteristics will be summarized as mean ± standard deviation, median (minimum-maximum), percentage, and frequency values. Qualitative data from the patient follow-up form will be categorized, converted into quantitative data, and presented as percentages and frequency distributions. After examining the normality of the data distribution, one-way analysis of variance (One-Way ANOVA) will be used to compare continuous variables showing a normal distribution among the three independent groups. For continuous variables that do not show a normal distribution, group comparisons will be performed using the Kruskal-Wallis H test. When a significant difference is found between groups, appropriate post-hoc analyses will be applied. The level of statistical significance will be set at p \< 0.05 with a 95% confidence interval.

Conditions

• Ureteroscopy

Interventions

Type	Name	Description
OTHER	Virtual Reality	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.
OTHER	Stress Ball	In 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.

Timeline

• Start date: 2026-02-02
• Primary completion: 2026-05-15
• Completion: 2026-12-15
• First posted: 2025-12-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: Turkey (Türkiye)