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

NCT07359794 | Completed

• 1 other identifier: NK
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Virtual Reality; Cystoscopy; Binaural Beats

Outcome Measures

Primary Outcomes (5)

• The Effect of VR and Binaural Beats on Anxiety

  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.

  4 month

• The Effect of VR and Binaural Beats on Pain

  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

  4 month

• The Effect of VR and Binaural Beats on blood pressure

  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 month

• The Effect of VR and Binaural Beats on pulse

  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

  4 month

• The Effect of VR and Binaural Beats on oxygen saturation

  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

  4 month

Study Arms (2)

Virtual reality and binaural beat

EXPERIMENTAL

Before cystoscopy During cystoscopy After cystoscopy

Other: Virtual reality headset and binaural beat listening

Standard care

NO INTERVENTION

Before cystoscopy During cystoscopy After cystoscopy

Interventions

Virtual reality headset and binaural beat listening OTHER

Nature video and binaural drumming experience with virtual reality headset

Virtual reality and binaural beat

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Male (Due to the shorter and straighter urethra in women and the procedure causing less discomfort, sampling is only included for male patients.),
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Yalova: lead

Study Sites (1)

Yalova University

Yalova, 34959, Turkey (Türkiye)

Location

Related Publications (4)

• Xiong J, Jiang X, Cai B, Zhao L, Zhang Q, Luo J. Binaural beats for perioperative anxiety and pain: A systematic review and meta-analysis. Complement Ther Med. 2025 Dec;95:103299. doi: 10.1016/j.ctim.2025.103299. Epub 2025 Oct 30.

  PMID: 41176178 BACKGROUND

• Tani A, Vagheggini G, Moretti F, Del Colombo V, Lehle J, Campana S, Labate A, Tomaiuolo F. Binaural Beats Reduce Postoperative Morphine Consumption in Older adults After Total Knee Replacement Surgery. Altern Ther Health Med. 2021 Mar;27(2):27-30.

  PMID: 32412916 BACKGROUND

• Ligree N, Nanda S, Morwal S, Garg K. Effect of binaural beat music and noise cancelling headphones on intraoperative anxiety in patients undergoing spinal anaesthesia - A randomised controlled study. Indian J Anaesth. 2023 Jul;67(7):590-594. doi: 10.4103/ija.ija_740_22. Epub 2023 Jul 14.

  PMID: 37601935 BACKGROUND

• Öner, N., Le Compte, A., Durumluk Sürekli Kaygı Envanteri El Kitabı, 2. Baskı, Boğaziçi Üniversitesi Yayınları, No:333, 1985.

  BACKGROUND

Study Officials

• NİRAN ÇOBAN

  University of Yalova

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 22, 2026
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 30, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)