NCT07572305

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

April 24, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

Liver transplantationVirtual realityPostoperative fatiguePostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Change in fatigue severity

    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 Outcomes (4)

  • Change in pain intensity

    Baseline and 15 minutes after intervention

  • Change in heart rate (beats per minute)

    Baseline and 15 minutes after intervention

  • Change in systolic and diastolic blood pressure (mmHg)

    Baseline and 15 minutes after intervention

  • Change in systolic and diastolic blood pressure (mmHg)

    Baseline and 15 minutes after intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: Virtual Reality Intervention

Control Group

ACTIVE COMPARATOR

Participants received routine postoperative care without any additional intervention

Other: Standard Care

Interventions

A 20 minute immersive virtual reality session was administered using a headmounted display during the early postoperative period following liver transplantation.

Experimental Group

Participants received routine postoperative care without any additional intervention

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Liver Transplantation Institute

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeFatigue

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to group allocation. Participants and care providers were not blinded due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either an experimental group receiving a 20-minute virtual reality intervention or a control group receiving standard care. Outcomes were measured before and 15 minutes after the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 7, 2026

Study Start

May 1, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations