Malatya Turgut Özal University
Malatya, 44900, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07689461
Total Hip Arthroplasty (THA), a procedure performed to enhance the quality of life, is accompanied by postoperative challenges such as pain and anxiety that adversely affect patient comfort. Inadequate management of these complications can prolong the length of hospital stay, delay recovery, lead to functional impairments, and elevate the risk of chronic pain development. Conventional pharmacological interventions employed for management are limited due to their potential for adverse effects and dependency. Virtual reality (VR) is a non-pharmacological distraction technique utilized in the healthcare sector, leveraging advanced technology to maximize patient comfort by alleviating pain and minimizing anxiety.
A review of the literature reveals that while the use of VR has positive effects on pain and anxiety, there is a notable scarcity of high-quality randomized controlled trials concurrently evaluating its impact on pain, anxiety, and comfort levels in postoperative orthopedic procedures such as THA. In this randomized controlled trial, participants in the control group will receive standard care, whereas those in the experimental group will receive a 30-minute VR intervention-offering three distinct options-in addition to standard care during the acute phase of the first 48 hours. Postoperative assessments will be conducted using the Visual Analogue Scale (VAS) for pain intensity, the State Anxiety Inventory for anxiety levels, and the Perianesthesia Comfort Scale for comfort levels.
By evaluating the potential of VR as a non-pharmacological adjuvant in post-THA care, the findings of this study will provide significant contributions to evidence-based nursing practices aimed at developing multimodal pain management strategies, reducing opioid consumption, and enhancing patient satisfaction.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Malatya, 44900, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient undergoing the virtual reality session will lie in a supine position, supported and comfortable, with the head elevated at an angle of 30˚-45˚. The content will feature nature sounds and soothing background music; three different segments will be programmed: a forest or beach landscape, an underwater scene, and an outdoor excursion. Each option consists of 30 minutes of footage. The patient will select their preferred footage from these options, and after the sound settings are adjusted to a level the patient finds comfortable and non-disturbing, the session will begin and last for 30 minutes. Following the session, data will be collected in a face-to-face setting.
Time frame: The first 24 hours after surgery, 25-48 hours after surgery
The Visual Analog Scale (VAS) was used to measure pain intensity; it is a simple, unidimensional measure. It was developed by Price et al. in 1983 to assess perceived pain. Compared to the VAS scale, which is known to be more sensitive in the assessment and characterization of acute pain, "no pain" is rated as 0 points and "most severe pain" as 10 points. On this scale, an increase in score indicates an increase in pain. Pain is also categorized as mild (<3), moderate (3-6), and severe (>6).
Time frame: The first 24 hours after surgery, 25-48 hours after surgery
The Spielberger State-Trait Anxiety Inventory was used to assess patients' anxiety levels. The original scale was developed in 1970 by Spielberger and his team and adapted to the Turkish language and culture by Öner and Le Compte. Scale items are answered on a four-point Likert-type scale. For the state anxiety scale, the response options are "not at all," "a little," "a lot," and "completely," while for the trait anxiety scale, they are "never," "sometimes," "most of the time," and "almost always." Higher scores on the scale indicate higher levels of anxiety, while lower scores indicate lower levels of anxiety. According to the score ranges established by Spielberger and colleagues, a score of 0-19 indicates no anxiety, 20-39 indicates mild anxiety, 40-59 indicates moderate anxiety, and 60-79 indicates severe anxiety.
Time frame: The first 24 hours after surgery, 25-48 hours after surgery
The comfort levels of postoperative patients were assessed using the Perianesthesia Comfort Scale. The scale was developed by Kolcaba in 1990 and adapted into Turkish by Üstündağ and Aslan (2010). The Perianesthesia Comfort Scale (PCS) is a self-report assessment tool designed to measure individuals' comfort levels during the perianesthesia period. The scale consists of a total of 24 items and uses a six-point Likert-type scale. Participants respond to each item with scores ranging from "strongly disagree (1)" to "strongly agree (6)." The total score that can be obtained from the scale ranges from 24 to 144. The total score is divided by the number of items to calculate the mean score, which is expressed as a value between 1 and 6. A low mean score indicates a low level of comfort, while a high mean score indicates a high level of comfort.
Contact information is provided by the study sponsor or research team.
BİLSEV DEMİR, Assoc. Prof.
CONTACT
5364083761 ext. +90
OĞUZHAN ÇAĞLAR, MSc Std
CONTACT
5423455495 ext. +90
Adiyaman University
Other
The Effect of Virtual Reality on Pain, Anxiety, and Comfort Levels After Total Hip Replacement Surgery
Acronym: THA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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