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Completed

NCT Number: NCT07359794

The Effect of Virtual Reality and Binaural Beats on Pain, Anxiety, and Vital Signs During Cystoscopy

This study was conducted as a randomized controlled trial to evaluate the effect of nature videos viewed through virtual reality goggles and binaural beat audio played during cystoscopy on pain, anxiety, and vital signs. The study was conducted between September 2025 and December 2025 with 60 patients who applied to the cystoscopy unit of a public hospital in Istanbul and met the inclusion criteria. Patients in the experimental group (n=30) were shown nature videos using virtual reality goggles and listened to binaural beats through headphones, while patients in the control group (n=30) received no intervention other than routine care. Research data were collected using the Patient Introduction Form, Visual Analog Scale, State Anxiety Scale, and Vital Findings Form.

It was determined that nature videos and binaural beats played through virtual reality goggles during cystoscopy reduced patients' pain and anxiety levels and positively affected their vital signs.

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Yalova University

Yalova, 34959, Turkey (Türkiye)

About this study

Although cystoscopy is a short procedure performed under local anesthesia, its invasive nature can cause pain, anxiety, and physiological stress responses in patients. This can negatively affect the patient's compliance and overall comfort during the procedure. In recent years, it has been reported that distracting, non-pharmacological, and technology-based applications in surgical and interventional procedures are effective in increasing patient comfort. This study was planned and conducted as a randomized controlled trial to evaluate the effect of nature videos viewed through virtual reality (VR) goggles and binaural beats listened to simultaneously during cystoscopy on patients' pain levels, anxiety levels, and vital signs.The study was conducted between September 2025 and December 2025 at the cystoscopy unit of a public hospital in Istanbul. A total of 60 patients scheduled for cystoscopy and meeting the inclusion criteria were enrolled in the study. Patients were randomly assigned to either the experimental (n=30) or control (n=30) group. Patients in the experimental group were shown nature-themed videos through virtual reality glasses and listened to binaural beats through headphones before and during the cystoscopy procedure. No additional interventions were performed on patients in the control group other than the routine care protocol applied in the clinic. Research data were collected using the Patient Introduction Form, which included patient characteristics; the Visual Analog Scale (VAS) to assess pain levels; the State Anxiety Scale to determine anxiety levels; and the Vital Signs Form, which included systolic-diastolic blood pressure, pulse, and respiratory rate. Measurements were taken before, during, and after the procedure.

The research results show that nature videos and binaural beats played through virtual reality goggles during cystoscopy are an effective intervention in reducing patients' pain and anxiety levels and positively affecting physiological parameters. Due to its non-invasive, low-cost, and easy-to-implement nature, this combination is considered to be a complementary nursing practice that can be integrated into clinical applications to enhance patient comfort during short-term procedures such as cystoscopy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 18 years of age or older,
  • Male (Due to the shorter and straighter urethra in women and the procedure causing less discomfort, sampling is only included for male patients.),
  • Planned for diagnostic or therapeutic rigid cystoscopy,
  • Undergoing cystoscopy for the first time,
  • Undergoing a cystoscopy procedure that does not require anesthesia,
  • Without any condition that prevents communication,
  • Without any visual impairment or condition that prevents the use of VR glasses,
  • Without mental disability or cognitive impairment,
  • Individuals who volunteered to participate in the study were included in the study.

Exclusion criteria

  • • Patients with contraindications for cystoscopy (allergic to lidocaine or other agents used, active urinary tract infection, anatomical problems related to the urethra)
  • Patients who have used analgesic (painkiller) medication within 24 hours prior to cystoscopy
  • Patients who will undergo additional manipulation during cystoscopy (Double J catheter placement or removal, bladder biopsy)
  • Patients who did not comply with the study process and conditions were not included in the study.

Treatment and study plan

Virtual reality headset and binaural beat listening

Other

Nature video and binaural drumming experience with virtual reality headset

Primary outcomes

  1. The Effect of VR and Binaural Beats on Anxiety

    Time frame: 4 month

    State Anxiety Inventory: In this study, the "State Anxiety Inventory (STAI-I)" will be used before and after the mandala coloring to assess patients' situational anxiety. The inventory evaluates how individuals feel at a particular moment. It includes 20 items, each scored from 1 (Not at all) to 4 (Completely), reflecting the intensity of the emotion experienced. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse scored. Total scores range from 20 to 80; higher scores indicate greater anxiety. Additionally, the "Trait Anxiety Inventory (STAI-II)" measures general anxiety independent of specific situations, using a similar 20-item structure with frequency-based responses. The full inventory contains 40 items. High scores on either scale indicate higher anxiety levels.Patients completed the questionnaire before and after cystoscopy.

  2. The Effect of VR and Binaural Beats on Pain

    Time frame: 4 month

    Visual Analog Scale: The Visual Analog Scale is a commonly used unidimensional measure for assessing pain intensity. The VAS is a measurement tool ranging from 0 to 10 cm (0 to 100 mm) in length.

    Since the aim of the study is to determine the effect of the non-pharmacological method used on existing pain, VAS will be used to assess pain before, during, and after cystoscopy

  3. The Effect of VR and Binaural Beats on blood pressure

    Time frame: 4 month

    Patients' blood pressure values will be recorded. The effect of non-pharmacological interventions on patients' blood pressure values will be evaluated. Evaluated before, during, and after the cystoscopy

  4. The Effect of VR and Binaural Beats on pulse

    Time frame: 4 month

    Patients' pulse , values will be recorded. The effect of non-pharmacological interventions on patients' pulse values will be evaluated.Evaluated before, during, and after the cystoscopy

  5. The Effect of VR and Binaural Beats on oxygen saturation

    Time frame: 4 month

    Patients' oxygen saturation , values will be recorded. The effect of non-pharmacological interventions on patients' oxygen saturation values will be evaluated.Evaluated before, during, and after the cystoscopy

Sponsors and collaborators

Lead sponsor

University of Yalova

Other

Registry information

Official study title

The Effect of Binaural Drumbeat Listening With Virtual Reality Goggles During Cystoscopy on Pain, Anxiety and Vital Signs

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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