The Effect of Virtual Reality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGiresun University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 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,
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Virtual Reality
Other interventionFifteen 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Virtual Reality GroupExperimental treatment 1 intervention
Trial outcomes
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."
Time frame
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
This is a 4-point Likert-type inventory consisting of 20 items that aims to determine how an individual feels at a given moment and under specific conditions. In the State Anxiety Inventory, the individual is asked to assess how they feel "right now" and to select one of the following statements based on the intensity of the feelings or behaviors expressed in the items: (1) "not at all," (2) "a little," (3) "a lot," and (4) "completely." A score of 4 is given for selecting "completely," and a score of 1 is given for selecting "not at all." A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.
Time frame
Patients' anxiety levels will be assessed before the chest tube removal procedure and 20 minutes after the procedure.Sponsors and contacts
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Giresun University
Lead sponsor
Giresun University Funding for Scientific Research Project
Collaborator
Source ClinicalTrials.gov
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