Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT07114003
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.
Detailed Description:
A pressure ulcer is a condition that occurs when local tissues in a patient are subjected to prolonged pressure, affecting blood circulation and causing pathological changes . Individuals exposed to prolonged pressure are at high risk of developing pressure ulcers due to local tissue compression, inadequate nutrition, and soft tissue necrosis. Pressure ulcers typically develop as a result of local factors (e.g., pressure, friction, shear, and/or moisture) acting at the level of bony prominences or mechanical pressure from medical devices (cable, cannula, drain, etc.). However, the formation of these wounds is multifactorial, and individual characteristics (age, comorbidities, nutritional status, etc.) also play an important role. With increasing life expectancy, the risk of pressure ulcers increases in older adults, critically ill patients, and those with spinal cord injury or disease. Despite preventive measures, the incidence of pressure ulcers has not decreased for decades. In addition to the risk of pain, infection, and death, the cost of treating pressure ulcers is also quite high. Therefore, developing practices to prevent and treat pressure ulcers is critical. According to the 2023 guidelines of the Wound Healing Society (WHS) and the European Tissue Repair Society (ETRS), pressure ulcers are frequently painful, and this pain is often associated with dressing changes (Level III). Uncontrolled pain can negatively impact patient compliance and quality of life, leading to anxiety. Kim et al.explained the factors affecting pain in pressure wounds with a proposed conceptual framework derived from the biopsychosocial model and emphasized that wound care nurses should implement interventions to reduce pain and anxiety. The duties of wound care nurses, an important part of the multidisciplinary healthcare team in wound care, are not limited to prevention and treatment strategies; they also encompass responsibilities focused on patient-centered, holistic management. The holistic care practices of wound care nurses have been shown to be generally associated with positive outcomes in terms of wound healing, pressure sore incidence, and treatment costs. Furthermore, the importance of considering the main symptoms frequently experienced by patients, such as pain, anxiety, depression, and stress, has been emphasized for a holistic assessment of wound care. In providing effective pain control, the combined application of both pharmacological and non-pharmacological methods with a multimodal approach is strongly emphasized. The almost complete absence of side effects, low cost, and ease of application of non-pharmacological methods used in pain management provide many advantages, such as saving labor and reducing the frequency of analgesic use. Virtual reality (VR) applications are used as a non-pharmacological treatment option to reduce acute and chronic pain and anxiety. More specifically, it is assumed that VR applications alter the negative emotions associated with previous pain experiences and reframe this experience in a positive way by giving the user the experience of being in a new environment. In the clinical setting, VR can also reduce the level of pain-related anxiety by altering the processing of cognitive and emotional affect signals in the central nervous system. By manipulating the environment, it constitutes an effective emotion-focused coping strategy by shifting the focus of attention away from unpleasant stimuli . The literature reports that VR application has positive effects on wound dressing changes and chronic pain. It has been reported that the use of VR during burn dressings positively affects children's physiological parameters and is effective in reducing fear, anxiety, and pain levels.
To our knowledge, no studies have been found in the literature specifically addressing the use of VR, a non-pharmacological method, in the dressing process of pressure ulcers. In this context, the proposed project makes a unique contribution to the literature by focusing solely on the use of VR in patients with pressure ulcers. In light of these considerations, the aim of this study was to evaluate the effects of VR use on pain and anxiety during dressing in patients with pressure ulcers, as well as patient satisfaction.
Study:
NCT07114003
Study Brief:
Protocol Section:
NCT07114003