NCT07794696

Brief Summary

This randomized controlled trial was conducted to evaluate the effects of family videos and virtual reality-based nature videos on anxiety, agitation, pain, and vital signs in adult intensive care unit patients. A total of 72 participants were randomly assigned to three parallel groups: a family video group (n=24), a family video plus virtual reality-based nature video group (n=24), and a standard care control group (n=24). Anxiety, agitation, pain, and vital signs were assessed before and after the interventions during the second and third days of intensive care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable anxiety

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

October 20, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 26, 2026

Last Update Submit

August 28, 2026

Conditions

Keywords

Intensive Care UnitFamily VideoFamily SupportVirtual RealityNature VideoAnxietyAgitationPainVital SignsNonpharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Level

    State anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-I). The scale consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety.

    Immediately before and after the intervention sessions on intensive care unit days 2 and 3.

Secondary Outcomes (1)

  • Agitation-Sedation Level

    Immediately before and after the intervention sessions on intensive care unit days 2 and 3.

Other Outcomes (6)

  • Pain Intensity

    Immediately before and after the intervention sessions on intensive care unit days 2 and 3.

  • Heart Rate

    Immediately before and after the intervention sessions on intensive care unit days 2 and 3.

  • Respiratory Rate

    Immediately before and after the intervention sessions on intensive care unit days 2 and 3.

  • +3 more other outcomes

Study Arms (3)

Family Video Intervention

EXPERIMENTAL

Family Video Intervention:Participants watched five-minute family videos twice daily on the second and third days of intensive care. Anxiety, agitation, pain, and vital signs were assessed immediately before and after the intervention.

Behavioral: Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care.

Family Video +Virtual Reality Group

EXPERIMENTAL

Family Video Plus Virtual Reality Group. Participants watched five-minute family videos twice daily and additionally viewed nature-themed videos using a virtual reality headset once daily for 15-20 minutes on the second and third days of intensive care. Anxiety, agitation, pain, and vital signs were assessed before and after the interventions.

Behavioral: Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care.

Standard Care Control

NO INTERVENTION

Standard Care Control Group. Participants received standard treatment and nursing care without a study-specific family video or virtual reality intervention. Outcomes were assessed at the same times and frequency as in the intervention groups.

Interventions

Participants viewed nature-themed video content using a virtual reality headset for approximately 15-20 minutes once daily on the second and third days of intensive care. The researcher remained with participants during the session and monitored for possible adverse effects.

Family Video +Virtual Reality GroupFamily Video Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-80 years
  • Hospitalized in an intensive care unit
  • Conscious and able to communicate
  • Willing to participate in the study
  • At least literate
  • Able to speak Turkish
  • No diagnosed psychiatric disorder
  • Hospitalized in the intensive care unit for at least two days

You may not qualify if:

  • Visual or hearing impairment
  • Being intubated
  • Cognitive, sensory, or verbal impairment preventing communication
  • Use of sedative, anxiolytic, or similar medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Ministry of Health Goztepe Training and Research Hospital

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPsychomotor AgitationPain

Condition Hierarchy (Ancestors)

Mental DisordersDyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants were randomly assigned to one of three parallel groups: a family video group, a family video plus virtual reality-based nature video group, or a standard care control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

October 20, 2024

Primary Completion

March 25, 2025

Study Completion

March 25, 2025

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations