AnxietyNCT07794696
Family Videos and Virtual Reality in Intensive Care Patients
A study testing Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care. in people with Anxiety and Agitation, run by Sennur Kula Şahin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2024to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Visual or hearing impairment
- Being intubated
- Cognitive, sensory, or verbal impairment preventing communication
- Use of sedative, anxiolytic, or similar medications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Ministry of Health Goztepe Training and Research Hospital
Istanbul, Istanbul, 34010
About this study
Official 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
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.
Read the detailed description
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
- Conditions
- Anxiety, Agitation, Pain, Physiological Parameters, Intensive Care
- Being tested
- Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care.
- Keywords
- Intensive Care Unit, Family Video, Family Support, Virtual Reality, Nature Video, Anxiety, Agitation, Pain, Vital Signs, Nonpharmacological Intervention
- Medical subject headings
- Anxiety Disorders, Psychomotor Agitation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before and after the intervention sessions on intensive care unit days 2 and 3.
Secondary outcomes (1)
Agitation-Sedation Level
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.
Measured: Immediately before and after the intervention sessions on intensive care unit days 2 and 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start20 Oct 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sennur Kula Şahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sennur Kula Şahin, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794696
- Sponsor's protocol ID
- FV-VR-ICU-2024-01
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07794696
- Acronym / sponsor ID
- FV-VR-ICU-2024-01
- Conditions
- Anxiety, Agitation, Pain, Physiological Parameters, Intensive Care
- Keywords
- Intensive Care Unit, Family Video, Family Support, Virtual Reality, Nature Video, Anxiety, Agitation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sennur Kula ŞahinUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Family Video Intervention | Experimental | 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 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. |
| Family Video +Virtual Reality Group | Experimental | 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 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-80 years
- Hospitalized in an intensive care unit
- Conscious and able to communicate
- Willing to participate in the study
- At least literate
Key exclusion criteria (4 listed)
- Visual or hearing impairment
- Being intubated
- Cognitive, sensory, or verbal impairment preventing communication
- Use of sedative, anxiolytic, or similar medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care.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. | Behavioural | Family Video +Virtual Reality Group, Family Video Intervention |
Primary outcome
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.
1 secondary outcome
Agitation-Sedation Level
Time frame: Immediately before and after the intervention sessions on intensive care unit days 2 and 3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care. in people with Anxiety and Agitation, run by Sennur Kula Şahin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Level (time frame: Immediately before and after the intervention sessions on intensive care unit days 2 and 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.