The Effect of Virtual Reality

NCT07283172 | Not Yet Recruiting

• 1 other identifier: BAEK-492
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chest tubes are routinely required during cardiothoracic procedures in open-heart surgeries. Postoperatively, these tubes are typically removed within 24-48 hours, and the removal process often causes patients to experience significant pain and discomfort due to the force applied. Among non-pharmacological strategies for managing procedural pain, distraction techniques are commonly used to divert patients' attention away from painful stimuli. In this context, the use of virtual reality (VR) headsets has recently emerged as an innovative method for pain management, effectively redirecting attention during invasive interventions. The aim of this study is to evaluate the effects of virtual reality on pain and anxiety levels during chest tube removal. This research is designed as a randomized controlled experimental trial. The study population will consist of patients undergoing open-heart surgery at the Cardiovascular Surgery Clinic of Giresun Training and Research Hospital. A total of 60 patients who meet the inclusion criteria and are representative of the study population will be recruited. Data will be collected using a Patient Identification Form developed by the researchers to assess sociodemographic characteristics, the Visual Analog Scale (VAS), and the State Anxiety Inventory. Participants will be randomly assigned to either the experimental or control group. Patients in the control group will receive routine care without additional intervention. In the experimental group, patients will be thoroughly informed about the VR procedure, including instructions on how to use the headset, details of the video content, and an explanation of the upcoming intervention. Five minutes before chest tube removal, the VR headset will be placed on the patient, and a video will be shown. The physician will then remove the chest tube(s) while the patient is engaged in the VR session. Pain intensity will be assessed at three time points: before chest tube removal, immediately after the procedure, and 20 minutes post-procedure. Anxiety levels will be evaluated twice: before the procedure and 20 minutes afterward. Data will be analyzed using SPSS version 22.0. Descriptive statistics, chi-square tests, and independent t-tests will be used for group comparisons, while repeated measures analysis of variance (R-ANOVA) will be employed for repeated measures.

Conditions

The Effects of Virtual Reality on Pain and Anxiety Levels During Chest Tube Removal

Keywords

Cardiac Surgery; Chest Tube; Virtual Reality; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  Visual Analog Scale (VAS) will be used to assess procedural pain. The VAS, which has undergone psychometric evaluation, is used to assess acute pain intensity in various patient populations, particularly to evaluate the effectiveness of treatment/intervention. In addition, many authors recommend using the VAS to measure the intensity of acute pain experienced during chest tube removal because it is easier and more understandable. The VAS is a 10 cm long scale that can be used horizontally or vertically, starting with "no pain" and ending with "unbearable pain."

  Participants' pain intensity (VAS) will be assessed three times: before chest tube removal, immediately after the procedure, and 20 minutes after the procedure.

Secondary Outcomes (1)

• State Anxiety Inventory

  Patients' anxiety levels will be assessed before the chest tube removal procedure and 20 minutes after the procedure.

Study Arms (2)

Control Group

NO INTERVENTION

Control Group

Virtual Reality Group

EXPERIMENTAL

Virtual Reality Group

Other: Virtual Reality

Interventions

Virtual Reality OTHER

Fifteen minutes before the chest tube removal procedure begins, patients' pain intensity will be measured using the "Visual Analog Scale (VAS)" and their anxiety level will be measured using the "State Anxiety Inventory" (1st MEASUREMENT). The researcher will provide each patient in the intervention group with detailed information about the virtual reality application, how to use the headset, what to do, the video content, and the procedure to be performed before the virtual reality application. Five minutes before the procedure, the virtual reality headset will be put on and the video will be shown. During the virtual reality application, all chest tubes will be removed by the physician. Immediately after the chest tube is removed, the intensity of pain felt by the patient during tube removal will be measured again using the VAS (2nd MEASUREMENT). Twenty minutes after the chest tube is removed, the patient's pain intensity will be measured again using the VAS, and their anxiety level

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older,
• Undergone open heart surgery and have a chest tube,
• Able to communicate verbally,
• Have not previously received any psychiatric diagnosis or treatment and are not taking psychiatric medication,
• Hemodynamic status is stable,
• Patients who agree to participate in the study will be included.

You may not qualify if:

• Patients who used analgesic medication immediately before the chest tube removal procedure,
• Patients with a history of chronic pain who routinely use analgesic medication,
• Patients who wear prescription glasses and have vision problems will not be included.

Sponsors & Collaborators

• Giresun University: lead
• Giresun University Funding for Scientific Research Project: collaborator

Study Sites (1)

Giresun University Health Sciences Faculty

Giresun, Piraziz, 28340, Turkey (Türkiye)

Location

Related Publications (4)

• Kok AY, Eyiler E. Effectiveness of breathing relaxation exercises on pain due to chest tube removal: a systematic review-meta-analysis. J Cardiothorac Surg. 2025 Jul 2;20(1):281. doi: 10.1186/s13019-025-03444-4.

  PMID: 40604937 RESULT

• Tsai CS, Tung HH, Fang CJ, Chen CT. Effectiveness of non-pharmacological interventions for pain reduction following chest tube removal: A systematic review and network meta-analysis. Intensive Crit Care Nurs. 2025 Apr;87:103909. doi: 10.1016/j.iccn.2024.103909. Epub 2024 Nov 29.

  PMID: 39615184 RESULT

• Demir Y, Khorshid L. The effect of cold application in combination with standard analgesic administration on pain and anxiety during chest tube removal: a single-blinded, randomized, double-controlled study. Pain Manag Nurs. 2010 Sep;11(3):186-96. doi: 10.1016/j.pmn.2009.09.002. Epub 2010 May 31.

  PMID: 20728068 RESULT

• Andreasen JJ, Sorensen GV, Abrahamsen ER, Hansen-Nord E, Bundgaard K, Bendtsen MD, Troelsen P. Early chest tube removal following cardiac surgery is associated with pleural and/or pericardial effusions requiring invasive treatment. Eur J Cardiothorac Surg. 2016 Jan;49(1):288-92. doi: 10.1093/ejcts/ezv005. Epub 2015 Feb 7.

  PMID: 25661079 RESULT

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Yeşim Yaman Aktaş, Professor

  Giresun University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeşim Yaman Aktaş, Professor

CONTACT

+90 5057756930; yesim.yaman@giresun.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

TU (1)