Effects of Virtual Reality and Stress Ball on Fear, Pain, Anxiety, and Satisfaction in Ureterorenoscopy Patients
Ureteroscopy
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 90 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Exclusion Criteria:
- Those who do not wish to participate or who wish to withdraw from the study, • Patients with chronic pain.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
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.
Other: Virtual Reality
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.
Other: Stress Ball
Control group
In the control group, the routine pre-procedure procedures and standard clinical practices will be applied
Virtual Reality 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 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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Anxiety
Time frame: 6 months
The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.
Procedure-Related Pain
Time frame: 6 months
Visual Analog Scale: It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain (Wewers and Lowe, 1990).
Secondary measures
Fear
Time frame: 6 months
Patients' fear will be assessed using a visual analog scale (VAS) ranging from 0 to 10; 0 represents "No fear at all," and 10 represents "Maximum fear." The minimum possible score is 0, and the maximum score is 10. Higher total scores indicate a higher level of fear experienced by the patient during or prior to the procedure.
Patient Satisfaction
Time frame: 6 months
Newcastle Satisfaction with Nursing Care Scale: Developed by Thomas et al. (1996), the Newcastle Satisfaction with Nursing Care Scale (NSNS) is used to assess the quality of nursing care in hospitals. The scale was adapted into Turkish by Uzun in 2003, and its validity and reliability were evaluated by Akın and Erdoğan in 2007 (Akin \& Erdogan, 2007). The scale consists of 19 items rated on a five-point Likert scale, with scores ranging from 1 (Not satisfied at all) to 5 (Very satisfied). The total score reflects the level of satisfaction with nursing care (minimum: 19, maximum: 95). In the original study, the reliability coefficient was 0.96, while in the Turkish adaptation it was 0.94, and 0.96 in the subsequent validity and reliability study.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
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1 locations
Tarsus UniversityMersin, Tarsus, Turkey (Türkiye)Status unknown
Study team and timeline
- Lead sponsor
- Tarsus University
- Study start
- Dec 24, 2025 Actual
- Primary completion
- Aug 15, 2026 Actual
- Study completion
- Aug 15, 2026 Actual
- First posted
- Dec 5, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Effect of Virtual Reality and Stress Ball Interventions on Procedure-Related Fear, Pain, Anxiety, and Patient Satisfaction in Patients Undergoing Ureterorenoscopy
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
