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

ConditionUreteroscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTarsus University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

• Aged 18 years or older,

Scheduled for ureteroscopy (URS),

Fully conscious, oriented, and cooperative,

Provided written informed consent to participate in the study,

Disqualifiers

Those who do not wish to participate or who wish to withdraw from the study, • Patients with chronic pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality

    Other intervention

    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 intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Virtual reality groupExperimental treatment 1 intervention
Group B: Stress Ball GroupExperimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Anxiety

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.

Time frame
6 months
2

Procedure-Related Pain

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).

Time frame
6 months

Secondary outcomes

1

Fear

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.

Time frame
6 months
2

Patient Satisfaction

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.

Time frame
6 months

Other outcomes

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