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

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed Show 7 more changesShow less
    • Primary completion pushed from May 15, 2026 to Aug 15, 2026
    • Study completion date changed from estimate of Dec 15, 2026 to Aug 15, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 2 of 2 entries
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 15, 2025 to Feb 2, 2026
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07265960
Lead Sponsor Tarsus University
Conditions
(from sponsor)
Ureteroscopy
Related terms Anxiety Disorders, Pain, Patient Satisfaction
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov