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Completed

NCT Number: NCT07794696

Family Videos and Virtual Reality in Intensive Care Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Ministry of Health Goztepe Training and Research Hospital

Istanbul, 34010, Turkey (Türkiye)

About this study

Intensive care unit patients may experience psychological and physiological problems such as anxiety, agitation, and pain because of the stressful and isolating nature of the intensive care environment. This randomized controlled trial evaluated family-based visual support and virtual reality-based nature videos as non-pharmacological supportive interventions in adult intensive care unit patients.

Participants were randomly assigned to one of three parallel groups. In the first intervention group, participants watched five-minute family videos twice daily. In the second intervention group, participants watched five-minute family videos twice daily and additionally viewed nature-themed videos using a virtual reality headset once daily for approximately 15-20 minutes. Participants in the control group received standard treatment and nursing care without a study-specific video or virtual reality intervention.

The interventions and assessments were performed on the second and third days of intensive care after the patients' clinical condition had been evaluated and approved by a physician. Anxiety, agitation, and pain were assessed immediately before and after the interventions. Vital signs were obtained from routine clinical monitoring records. During virtual reality sessions, the researcher remained with the participant and monitored for possible adverse effects such as dizziness

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Visual or hearing impairment

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

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. State Anxiety Level

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

    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.

Secondary outcomes

  1. Agitation-Sedation Level

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

    Agitation and sedation were assessed using the Richmond Agitation-Sedation Scale (RASS), which ranges from -5 to +4. Positive scores indicate increasing levels of agitation, 0 indicates an alert and calm state, and negative scores indicate increasing levels of sedation.

Other outcomes

  1. Pain Intensity

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

    Pain intensity was assessed using a Numerical Pain Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain.

  2. Heart Rate

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

    Description: Heart rate was recorded before and after the intervention sessions.

    Time Frame: Immediately before and after the intervention sessions on intensive care unit days 2

  3. Respiratory Rate

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

    Respiratory rate was recorded before and after the intervention sessions.

  4. Systolic Blood Pressure

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

    Systolic blood pressure was recorded before and after the intervention sessions.

  5. Diastolic Blood Pressure

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

    Diastolic blood pressure was recorded before and after the intervention sessions.

  6. Body Temperature

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

    Body temperature was recorded before and after the intervention sessions.

Sponsors and collaborators

Lead sponsor

Sennur Kula Şahin

Other

Registry information

Official study title

Effects of Family Videos and Virtual Reality-Based Nature Videos on Anxiety, Agitation, Pain, and Vital Signs in Intensive Care Patients: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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