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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-02

Study Completion Date

2026-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy

NCT06079814

Pain Anxiety

RECRUITING NA

The Effect of Musical Video With Virtual Reality Goggles on Patient's Anxiety and Comfort During Ureteroscopy

NCT06914830

Ureteroscopy Operation Time Music Listening

ACTIVE_NOT_RECRUITING NA

Effect of Virtual Reality Goggles on Pain, Anxiety and Hemodynamic Variables During Urodynamics

NCT06528925

Virtual Goggles Urodynamics Pain +2 more

COMPLETED NA

The EFFECT of VİRTUAL REALİTY (VR) HEADSET USE on ANXİETY LEVELS DURİNG URODYNAMİC TESTİNG

NCT06905665

Virtual Reality Headsets Reduce Anxiety During Urodynamic Tests

COMPLETED NA

Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial

NCT06342193

Cystoscopy Virtual Reality Anxiety

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Ureteroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The allocation of patients included in the study to groups will be performed by a researcher not involved in the data collection (YG) using a simple randomization method with a random number table. The table will be generated using the website https://www.randomizer.org/. When a patient scheduled for ureterorenoscopy arrives at the urology clinic, the principal investigator (GB) and researcher (ESS) will assess the patient according to the inclusion criteria. If the patient meets the inclusion criteria and signs the informed consent form, GB and ESS will inform YG, who will assign the patient to a group and notify GB of the assignment. In this way, all researchers other than YG, the patients, their relatives, and clinical staff will be blinded to group allocation. To prevent bias in statistical analyses, the data of patients whose data collection is complete will be entered into the database by YG coded as K1, K2, and K3 without specifying group names, and the analyses will be conduc

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Stress Ball

Intervention Type OTHER

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.

Control group

In the control group, the routine pre-procedure procedures and standard clinical practices will be applied

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • 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.