Effects of Virtual Reality Application on Pain, Anxiety, and Patient Satisfaction in Dressing Patients With Pressure Sores

NCT07114003 | Recruiting

• 1 other identifier: Tarsus University
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Pressure ulcers are serious and costly wounds that typically develop as a result of impaired blood flow in tissues exposed to prolonged pressure. They are particularly at risk in the elderly, critically ill patients, and individuals with limited mobility. Pain and anxiety during dressing applications for pressure ulcers can negatively impact patient comfort and compliance. There are limited studies in the literature on the use of nonpharmacological methods to reduce pain and anxiety during the dressing process for pressure ulcers. Virtual reality (VR) applications stand out as an effective method for managing pain and anxiety by providing distraction. However, existing studies generally cover all chronic wounds and lack specific research on the use of VR during the dressing process in individuals with pressure ulcers. Therefore, the proposed study aims to examine the effects of VR application during dressing on pain, anxiety, and patient satisfaction in patients with pressure ulcers and aims to make an original contribution to the literature.

Conditions

Pressure Wounds

Keywords

Virtual Reality; Pain; Anxiety; Patient Satisfaction

Outcome Measures

Primary Outcomes (3)

• Pain assessment

  In measuring pain, a visual assessment scale (VAS) will be used, where the evaluation is made by making marks on a 100 mm or 10 cm vertical or horizontal line, where there is no pain at one end and the most severe pain at the other end. Pain will be measured using a visual analog scale (VAS), which uses markings on a 100 mm or 10 cm vertical or horizontal line, with no pain at one end and the most severe pain at the other. Pain will be measured before, during, and after dressing application.

  Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes

• Anxiety Assesment

  State Trait Anxiety Inventary will be used. Before the dressing, the state and trait anxiety inventories will be administered. After the dressing, the state anxiety inventory will be administered again to assess anxiety. This constant value is 50 for state anxiety and 35 for trait anxiety. The resulting value represents the individual's anxiety score. Interpretation of Scores: The total score obtained from both scales ranges from 20 to 80. A higher score indicates a higher level of anxiety, while a lower score indicates a lower level of anxiety.

  Before the Procedure and baseline, after an average of 20-30 minutes

• Patient satisfaction

  Patients will be asked about their satisfaction with the application (not satisfied, undecided, satisfied, very satisfied) and the experimental group will be asked whether they would like to use the SG application again.

  baseline, after an average of 20-30 minutes

Study Arms (2)

Virtual reality (Experimental Group)

EXPERIMENTAL

In the experimental group, a distraction-inducing intervention will be performed using virtual reality goggles. Unlike traditional methods, the VR goggle method is designed to provide patients with an interactive experience in a visual and auditory environment. The audio and video content of the VR program will be determined by drawing inspiration from proven studies and consulting with healthcare professionals with clinical experience. This method aims to create a stronger distraction effect and achieve greater effectiveness in pain and anxiety management. Pain levels will be measured from all participants before, during, and after the dressing application; a state anxiety inventory will be completed after the dressing application.

Behavioral: virtual reality application

Routine Care (Control Group)

NO INTERVENTION

All participating patients will be interviewed in the clinic to obtain written informed consent. A personal information form and a state-trait anxiety inventory will be completed. All participants will receive standard treatment and nursing practices during wound care. These practices include proper wound cleaning, use of aseptic techniques for infection control, and thorough implementation of dressing procedures. Additionally, routine distraction methods (e.g., listening to music, talking to the patient, reading a book) are recommended and implemented by the nurses in the clinic, depending on the patient's preference.

Interventions

virtual reality application BEHAVIORAL

The Oculus Meta Quest Pro is a virtual reality headset with 256 GB of storage. Its LCD screen offers a resolution of 1800 x 1920 pixels per eye and supports refresh rates from 90 Hz to 120 Hz. It is powered by a Qualcomm Snapdragon XR2+ processor. It features eye tracking and facial tracking, controllers with TruTouch haptics and precision tracking, and built-in 3D spatial audio support. The program, which will be played through the VR headset, is designed to use licensed programs featuring nature scenes (forest, sea, beach, etc.) and relaxing music for 20-30 minutes. The program content will be created by selecting nature sounds and music known to be effective in reducing stress and anxiety. To ensure the program's internal validity, the opinions of healthcare professionals with clinical experience will be obtained to assess whether the program achieves the intended relaxing effect.

Virtual reality (Experimental Group)

Eligibility Criteria

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

You may qualify if:

• Participants will be individuals aged 18 and over (inclusive), who have no hearing/visual impairment, do not have epilepsy, vertigo, or claustrophobia, and who agree to participate in the study.

You may not qualify if:

• Patients who exhibit symptoms of cybersickness (dizziness, nausea, etc.) due to the VR application, who require analgesia during the intervention, or who do not feel pain due to neuropathy, and who express their wish to withdraw from the study will be excluded from the study.

Sponsors & Collaborators

• Cukurova University: lead
• Toros University: collaborator

Study Sites (1)

Tarsus University

Mersin, Tarsus, 33400, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• Kilic U, Tural Buyuk E. The Effect of Using Virtual Reality During Burn Dressing on Pain, Anxiety and Fear Felt in Children: A Randomized Controlled Trial. J Burn Care Res. 2024 Aug 6;45(4):949-957. doi: 10.1093/jbcr/irae005.

  PMID: 38224569 BACKGROUND

• Gould LJ, Alderden J, Aslam R, Barbul A, Bogie KM, El Masry M, Graves LY, White-Chu EF, Ahmed A, Boanca K, Brash J, Brooks KR, Cockron W, Kennerly SM, Livingston AK, Page J, Stephens C, West V, Yap TL. WHS guidelines for the treatment of pressure ulcers-2023 update. Wound Repair Regen. 2024 Jan-Feb;32(1):6-33. doi: 10.1111/wrr.13130. Epub 2023 Dec 20.

  PMID: 37970711 BACKGROUND

• Gefen A, Alves P, Ciprandi G, Coyer F, Milne C, Ousey K, Ohura N, Waters N, Worsley P, Black J, Barakat-Johnson M, Beeckman D, Fletcher J, Kirkland-Kyhn H, Lahmann NA, Moore Z, Payan Y, Schluer AB. An international consensus on device-related pressure ulcers: SECURE prevention. Br J Nurs. 2020 Mar 12;29(5):S36-S38. doi: 10.12968/bjon.2020.29.5.S36.

  PMID: 32167820 BACKGROUND

• Fearns N, Heller-Murphy S, Kelly J, Harbour J. Placing the patient at the centre of chronic wound care: A qualitative evidence synthesis. J Tissue Viability. 2017 Nov;26(4):254-259. doi: 10.1016/j.jtv.2017.09.002. Epub 2017 Sep 5.

  PMID: 28893459 BACKGROUND

• Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.

  PMID: 27749790 BACKGROUND

• Dowsett C. T.I.M.E. to improve patient outcomes: use of a clinical decision support tool to optimise wound care. Br J Community Nurs. 2019 Mar 1;24(Sup3):S6-S11. doi: 10.12968/bjcn.2019.24.Sup3.S6.

  PMID: 30817187 BACKGROUND

• Coleman S, Gorecki C, Nelson EA, Closs SJ, Defloor T, Halfens R, Farrin A, Brown J, Schoonhoven L, Nixon J. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013 Jul;50(7):974-1003. doi: 10.1016/j.ijnurstu.2012.11.019. Epub 2013 Feb 1.

  PMID: 23375662 BACKGROUND

• Chuan A, Zhou JJ, Hou RM, Stevens CJ, Bogdanovych A. Virtual reality for acute and chronic pain management in adult patients: a narrative review. Anaesthesia. 2021 May;76(5):695-704. doi: 10.1111/anae.15202. Epub 2020 Jul 27.

  PMID: 32720308 BACKGROUND

• Choi T, Heo S, Choi W, Lee S. A Systematic Review and Meta-Analysis of the Effectiveness of Virtual Reality-Based Rehabilitation Therapy on Reducing the Degree of Pain Experienced by Individuals with Low Back Pain. Int J Environ Res Public Health. 2023 Feb 16;20(4):3502. doi: 10.3390/ijerph20043502.

  PMID: 36834197 BACKGROUND

• Boyko TV, Longaker MT, Yang GP. Review of the Current Management of Pressure Ulcers. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):57-67. doi: 10.1089/wound.2016.0697.

  PMID: 29392094 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Derya GEZER, Asisstant Professor

  Tarsus University

  PRINCIPAL INVESTIGATOR

• Esma Gökçe, Asisstant Professor

  Toros University

  STUDY DIRECTOR

• Dudu Alptekin, Dr

  Cukurova University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derya GEZER, Asisstant Professor

CONTACT

+905076990081; deryasahhin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will be conducted as a two-group, repeated-test design, experimental, randomized controlled interventional study aiming to evaluate the effect of VR application.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 11, 2025
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TU (1)