- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07572305
Effects of Virtual Reality After Liver Transplantation (VR-LT)
Effects of Virtual Reality on Pain, Fatigue and Vital Signs After Liver Transplantation A Randomized Controlled Trial
This randomized controlled study aims to evaluate the effects of a virtual reality intervention on pain, fatigue and vital signs in patients during the early postoperative period after liver transplantation. Postoperative symptoms such as pain and fatigue may negatively affect recovery and patient comfort. Virtual reality has emerged as a non-pharmacological method that may help reduce these symptoms by providing distraction and relaxation.
A total of 84 patients were randomly assigned to an experimental group or a control group. The experimental group received a 20-minute virtual reality session, while the control group received standard care. Pain, fatigue and vital signs were measured before and after the intervention.
This study aims to determine whether virtual reality can improve patient comfort and physiological stability and support recovery after liver transplantation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a prospective, randomized controlled, single-blind trial to evaluate the effects of a virtual reality intervention on pain, fatigue, and vital signs in patients during the early postoperative period after liver transplantation.
Liver transplantation is a life-saving procedure; however, patients frequently experience postoperative symptoms such as pain and fatigue, which may negatively affect recovery, physiological stability, and overall patient comfort. Non-pharmacological interventions have gained increasing attention in recent years as supportive approaches to improve postoperative outcomes. Virtual reality is an emerging technology that provides immersive distraction and relaxation, potentially reducing symptom perception and enhancing patient well-being.
The study was conducted in the organ transplantation clinic of a university hospital between May 2025 and January 2026. A total of 84 patients who met the inclusion criteria were randomly assigned to either the experimental group (n=42) or the control group (n=42) using a computer-based randomization method.
Patients in the experimental group received a 20-minute virtual reality intervention during the early postoperative period, while patients in the control group received standard care without additional intervention. Pain levels were assessed using the Numerical Rating Scale (NRS), fatigue levels were measured using the Brief Fatigue Inventory (BFI), and vital signs including heart rate, respiratory rate, and blood pressure were recorded. All measurements were obtained before the intervention and 15 minutes after the intervention.
The primary objective of the study was to determine the effect of virtual reality on fatigue levels. Secondary outcomes included pain and vital signs. Data were analysed using appropriate statistical methods, and statistical significance was set at p<0.05.
This study aims to contribute to the evidence base regarding the effectiveness of virtual reality as a non-pharmacological nursing intervention and to support its integration into clinical practice to improve postoperative care in liver transplantation patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Malatya, Turkey (Türkiye)
- Inonu University Liver Transplantation Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years
- Underwent liver transplantation
- In the early postoperative period
- Able to communicate verbally
- No diagnosed psychiatric disorder
- Hemodynamically stable
- Pain score ≥4 on the Numerical Rating Scale (NRS)
- Willing to participate in the study
Exclusion Criteria:
- Presence of severe postoperative complications
- Cognitive impairment or inability to understand instructions
- Visual or hearing impairments preventing use of virtual reality
- History of motion sickness or vertigo related to virtual reality use
- Chronic diseases that may affect fatigue or vital signs (e.g., uncontrolled cardiovascular or respiratory diseases)
- Refusal to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Participants received a 20 minute virtual reality intervention during the early postoperative period following liver transplantation.
The intervention was administered using a head mounted display and aimed to reduce fatigue and improve physiological parameters
|
A 20 minute immersive virtual reality session was administered using a headmounted display during the early postoperative period following liver transplantation.
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Active Comparator: Control Group
Participants received routine postoperative care without any additional intervention
|
Participants received routine postoperative care without any additional intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fatigue severity
Time Frame: Baseline and 15 minutes after intervention
|
Change in fatigue severity measured using the Brief Fatigue Inventory (BFI) total score (range: 0-10; higher scores indicate greater fatigue)
|
Baseline and 15 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity
Time Frame: Baseline and 15 minutes after intervention
|
Measured using the Numerical Rating Scale (NRS) (range: 0-10; higher scores indicate greater pain)
|
Baseline and 15 minutes after intervention
|
|
Change in heart rate (beats per minute)
Time Frame: Baseline and 15 minutes after intervention
|
Change in heart rate measured in beats per minute (bpm).
Heart rate was recorded as part of routine vital sign monitoring to evaluate the physiological response to the virtual reality intervention.
Lower values may indicate improved relaxation and autonomic stability.
|
Baseline and 15 minutes after intervention
|
|
Change in systolic and diastolic blood pressure (mmHg)
Time Frame: Baseline and 15 minutes after intervention
|
Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Blood pressure was recorded as part of routine vital sign monitoring to evaluate the cardiovascular response to the virtual reality intervention.
Lower values may indicate improved physiological stability and relaxation.
|
Baseline and 15 minutes after intervention
|
|
Change in systolic and diastolic blood pressure (mmHg)
Time Frame: Baseline and 15 minutes after intervention
|
Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Blood pressure was assessed as part of routine vital sign monitoring to evaluate the cardiovascular response to the intervention.
Lower values may indicate improved physiological stability.
|
Baseline and 15 minutes after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Fatigue
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- 25H04 (Other Grant/Funding Number: Malatya Turgut Ozal University Scientific Research Projects Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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