NCT07704008

Brief Summary

This randomized controlled experimental study was conducted to evaluate the effects of virtual reality glasses used during hemodialysis on patients' vital signs and anxiety levels. A total of 56 adult patients receiving hemodialysis at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital were randomly assigned to either an experimental group or a control group. Patients in the experimental group watched a 4K virtual reality nature video with relaxing background music during hemodialysis, while the control group received standard hemodialysis care. Vital signs, pain, anxiety, and satisfaction were assessed to evaluate the effectiveness of the virtual reality intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 28, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

HemodialysisVirtual RealityVirtual Reality GlassesAnxietyVital SignsNursingRandomized Controlled Trial

Outcome Measures

Primary Outcomes (7)

  • Change in Systolic Blood Pressure

    Change in systolic blood pressure measured before and after the hemodialysis session.

    Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

  • Change in Diastolic Blood Pressure

    Change in diastolic blood pressure measured before and after the hemodialysis session.

    Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

  • Change in Heart Rate

    Change in heart rate measured before and after the hemodialysis session.

    Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

  • Change in Respiratory Rate

    Change in respiratory rate measured before and after the hemodialysis session.

    Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

  • Change in Peripheral Oxygen Saturation (SpO₂)

    Change in peripheral oxygen saturation (SpO₂) measured before and after the hemodialysis session.

    Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

  • Change in Body Temperature

    Change in body temperature measured before and after the hemodialysis session.

    Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

  • State Anxiety Level After Hemodialysis

    State anxiety measured using the State Anxiety Inventory (STAI-State), a 20-item questionnaire with total scores ranging from 20 to 80. Higher scores indicate greater levels of state anxiety. Assessment was performed immediately after completion of the hemodialysis session.

    Immediately after completion of the hemodialysis session.

Secondary Outcomes (2)

  • Change in Pain Score

    Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

  • Participant Satisfaction Score

    Immediately after completion of the hemodialysis session.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants received a virtual reality intervention during hemodialysis in addition to standard care.

Device: Virtual Reality GlassesOther: Standard Hemodialysis Care

Control Group

ACTIVE COMPARATOR

Participants received standard hemodialysis care without any additional intervention.

Other: Standard Hemodialysis Care

Interventions

Participants wore virtual reality glasses at the start of the hemodialysis session and viewed a 4K nature video with calming background music for 15 minutes. The intervention was administered once during the hemodialysis session in addition to standard hemodialysis care.

Experimental Group

Participants received routine hemodialysis care according to the standard clinical practice of the dialysis unit without any additional intervention.

Control GroupExperimental Group

Eligibility Criteria

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

You may qualify if:

  • Receiving hemodialysis treatment for the first time.
  • Age ≥18 years.
  • No visual, hearing, or cognitive impairment.
  • Able to communicate effectively.
  • Clinically stable.
  • No diagnosed psychiatric disorder or use of psychiatric medication.
  • No history of seizures.
  • Willing and able to provide informed consent.

You may not qualify if:

  • Previous hemodialysis treatment.
  • Age \<18 years.
  • Visual, hearing, or cognitive impairment.
  • History of kidney transplantation.
  • Communication difficulties.
  • Diagnosed psychiatric disorder or use of psychiatric medication.
  • History of seizures.
  • Declined to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal InsufficiencyAnxiety Disorders

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMental Disorders

Study Officials

  • Hilal Tüzer, Assoc. Prof.

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the experimental group (virtual reality intervention) or the control group (standard care) and remained in their assigned groups throughout the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2026

First Posted

July 15, 2026

Study Start

May 3, 2023

Primary Completion

May 27, 2024

Study Completion

May 27, 2024

Last Updated

July 15, 2026

Record last verified: 2026-06

Locations