NCT07471152

Brief Summary

This study aims to evaluate the effect of a Virtual Reality (VR)-based relaxation intervention on perceived stress, anxiety, and fatigue levels among intensive care unit (ICU) nurses. The ICU environment is characterized by high-intensity workloads and emotional demands, which often lead to increased psychological and physical strain on nursing staff

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 9, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Virtual Reality Glasses

Outcome Measures

Primary Outcomes (3)

  • The Perceived Stress Scale-10

    Developed to assess the level of stress individuals have perceived in their lives over the past month. The scale, developed by Sheldon Cohen et al., consists of 10 items. It is a 5-point Likert scale, with items scored from "0=Never" to "4=Very often". Items 4, 5, 7, and 8 are reverse-scored. The total score obtainable from the scale ranges from 0 to 40, with higher scores indicating a high level of perceived stress. The Turkish validity and reliability study of the scale was conducted by Ersin Eskin et al.

    after the 3 consecutive days of intervention

  • State Anxiety Scale

    The State Anxiety Scale developed by Spielberger et al. aims to measure the level of anxiety experienced by individuals at a specific time and under specific conditions. Validity and reliability studies of the scale in Turkey were conducted by Öner and Le Comte (Öner and Le Comte, 1983). The SAS consists of 20 items and is designed to assess situational anxiety. The scale has a 4-point Likert-type response format, with scores ranging from 20 to 80; higher scores indicate higher levels of anxiety. The Cronbach alpha coefficient of the SAS in the original study was found to be 0.94 (Öner and Le Comte, 1983). In this study, the Cronbach alpha coefficient was found to be 0.93.

    after the 3 consecutive days of intervention

  • Fatigue Severity Scale

    Developed to assess the impact and severity of fatigue on daily life in individuals. The scale was developed by Krupp et al. Consisting of 9 items, the scale uses a 7-point Likert scale, with items scored between 1 (strongly disagree) and 7 (strongly agree). The total score or item mean obtained from the scale indicates the severity of fatigue; higher scores indicate a higher level of fatigue. The Turkish validity and reliability study of the scale was conducted by Armutlu et al.

    after the 3 consecutive days of intervention

Study Arms (2)

Experiment Group

EXPERIMENTAL

Virtual Reality Glasses Group

Behavioral: virtual reality glasses

Control group

NO INTERVENTION

the group that did not make virtual reality glasses

Interventions

The group that made the virtual reality headset

Experiment Group

Eligibility Criteria

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

You may qualify if:

  • Being 18 years of age or older
  • Actively working in the intensive care unit of the relevant hospital for at least six months,
  • Working on an alternating shift basis (such as 24-hour work - 24-hour rest) during the research period,

You may not qualify if:

  • Having neurological disorders (epilepsy, migraine, vertigo, etc.) that may cause loss of balance or severe nausea during the virtual reality application,
  • Being required to wear prescription glasses due to the technical structure of the VR headset (physical compatibility of the device),
  • Having previously experienced any virtual reality (VR) application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat university

Elâzığ, Center, 25240, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

July 1, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations