Respiratory DistressNCT06886828
Virtual Reality Application During High Flow Nasal Oxygen Therapy in Children Effect on Anxiety Levels
A study testing Virtual reality goggles during HFNC and HFNC oxygen therapy with routine service application in people with Respiratory Distress, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Determination of the effect of virtual reality goggles used during high-flow oxygen therapy on child anxiety in children Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Respiratory Distress
- What is being tested?
- Virtual reality goggles during HFNC and HFNC oxygen therapy with routine service application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child is between 6-12 years old
- The child is receiving high flow nasal cannula oxygen therapy in the paediatric intensive care unit
- The child has no visual and hearing problems
- No pain according to the Wong-Baker pain scale
- No genetic, congenital, chronic or metabolic disease
- Being conscious and able to communicate verbally
- Written and verbal acceptance of the child and his/her parents to participate in the study after the information.
Who cannot join
- The child is in pain.
- The child is taking a sedative medication
- The child has a fever above 37°C
- The child presented with a severe asthma attack
- The child's saturation value was below 92% at the time of admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital
Istanbul, Sancaktepe
İlhan Varank Sancaktepe Training and Research Hospital Training and Research Hospital, +902166063300, istanbuleah35.bsh@saglik.gov.tr
Tuğba Karakaya
About this study
Official title: Virtual Reality Application During High Flow Nasal Oxygen Therapy in Children Effect on Anxiety Levels: A Randomised Controlled Study
Determination of the effect of virtual reality goggles used during high-flow oxygen therapy on child anxiety in children
Read the detailed description
Respiratory system diseases are frequently seen in childhood and hospitalised constitute a significant portion of the applications. Children continue their treatment in paediatric clinics or intensive care units according to their clinical conditions. In paediatric intensive care units, patients need respiratory support at various rates and respiratory support therapies are among the most commonly used treatment methods in paediatric intensive care clinics. Oxygen given to the appropriate patient under appropriate conditions treatment accelerates the healing process of the disease and prevents the progression of the current situation in a bad course and reduces mortality and morbidity. Oxygen therapy in hospitalised children invasive or non-invasive methods. Invasive method is the treatment method in which endotracheal intubation and mechanical ventilator are used. Noninvasive oxygen therapies are basically analysed in two groups as low-flow and high-flow applications. Low flow oxygen therapy is applied with nasal cannula, hood and tent system, simple face mask, reservoir mask and diffuser mask. High-flow oxygen systems include venturi mask, continuous positive airway pressure (cpap) therapy, bi-level positive airway pressure (bipap) therapy and high-flow nasal cannula oxygen therapy (HFNC). HFNC therapy is a non-invasive form of respiratory support that allows the delivery of high flow (30-60 L/min) of humidified and heated air (31 to 37°C) at a certain oxygen concentration (21-100%) through a nasal cannula, which can be used in the treatment of acute and chronic diseases with values appropriate to the patient's age/body weight and needs. Compared to normal nasal cannula and face mask, HFNC provides a higher level of respiratory support.
can happen. Children experience discomfort and anxiety due to the pressure created by the flow rate and the sound made by the device, and discomfort from the nasal cannula causes resistance to treatment. Nurses are responsible for implementing HFNC, observing the effectiveness of the treatment, monitoring children during HFNC and maintaining their daily life activities, and in this process, they benefit from evidence-based nursing practices. Medical procedures encountered during hospitalisation are the main source of fear for children. They may experience anger, helplessness and anxiety due to reasons such as unfamiliar environment, change in the routine of the child, different sound, light, tools and equipment, unfamiliar people, painful painful procedures, being away from family and friends, loss of control, activity limitation, communication difficulties, presence of other children crying. The use of technology in preparation for or during medical procedures is an effective method in providing anxiety and comfort. At the same time, respiratory distress experienced by children causes anxiety, dyspnoea and increased respiratory rate. In addition to the provision of effective respiratory support, it is important to improve children's experience of the hospital process and In order to support long-term physical and psychosocial health, it is necessary to utilise distraction methods for anxiety management. Nurses is independently involved in the management of oxygen therapy to prevent and protect patients from the adverse effects of hypoxaemia. Distraction methods, atraumatic care It is one of the non-pharmacological methods among the approaches and is used to control pain, stress and anxiety. There are many methods used to divert attention.
Some of them are; watching cartoons, hypnotherapy, playing with toys, using virtual reality, music therapy, play therapy, using kaleidoscope and using distraction cards. This study was planned to determine the effect of virtual reality used during high flow nasal cannula oxygen therapy on physiological parameters and anxiety levels in children aged 6-12 years.
- Conditions
- Respiratory Distress
- Being tested
- Virtual reality goggles during HFNC, HFNC oxygen therapy with routine service application
- Keywords
- high flow nasal oxygen therapy, virtual reality, Anxiety, distraction of attention, child
- Medical subject headings
- Dyspnea, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality goggles during HFNCDevice
HFNC oxygen therapy will be started with video demonstration accompanied by virtual reality glasses. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the study, only the behaviours of the child during the procedure should be video recorded by a mobile phone. For the participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated instantly by a researcher independent from the study. The study will continue until the 30-person intervention group is completed.
HFNC oxygen therapy with routine service applicationDevice
HFNC oxygen therapy will be started with routine ward practice. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the research, only the behaviours of the child during the procedure should be video-recorded by means of a mobile phone. For participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated instantly by a researcher independent from the study
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | Pre-Procedure: Information about the study will be given. Children with a pain score of '0' will be included in the groups. Verbal and written consent will be obtained from those who voluntarily agree to participate in the study. Video recording will be started with a mobile phone. Physiological parameters and anxiety level of the children will be measured and recorded 1 minute before the treatment. HFNC oxygen therapy will be started with video demonstration accompanied by virtual reality glasses. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the study, only the behaviours of the child during the procedure should be video recorded by means of a mobile phone. For participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated ins Receives: Device: Virtual reality goggles during HFNC |
| routine procedure | Active comparator | Information about the study will be given. Children with a pain score of '0' will be included in the groups. Verbal and written consent will be obtained from those who voluntarily agree to participate in the study. Video recording will be started with a mobile phone. Physiological parameters and anxiety level of children will be measured and recorded 1 minute before the treatment. HFNC oxygen therapy will be started with routine ward practice. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the research, only the behaviours of the child during the procedure should be video-recorded by means of a mobile phone. For participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated instantly by a researcher independent from the study. Receives: Device: HFNC oxygen therapy with routine service application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Emotional Manifestation Scale-CEMS
It was developed in 2003 by William Li and Lopez to assess the level of anxiety in children aged 7-12 years. The Turkish validity and reliability of the scale was carried out by Yanık et al. in 2019 with the approval and opinion of William Li and Lopez on the appropriateness of evaluating anxiety in children aged 3-6 years. The scale has 5 different categories and 25 items and is used to assess the anxiety level of children aged 3-12 years during medical interventions. In the facial expression category, the facial expressions of the child are evaluated by the researcher. In the vocalisation category, tear status is evaluated. In the movement category, the child's body language is evaluated. In the interaction category, the child's verbal/non-verbal communication status is evaluated. In the cooperation category, the child's active / passive participation is evaluated. Each category is between 1-5 points and a total score between 5-25 points is obtained. Cronbach's Alpha value is 0.969.
Measured: 1 minute before the start of the procedure and 1 minute after 10 minutes of VR viewing
Secondary outcomes (1)
Wong and Baker Faces Pain Scale
This scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983 and is a tool used to assess the level of pain in children aged 3-18 years who can communicate. In this scale, face shapes are used for children to express their pain level. Each face shape has a numerical equivalent. In the scale, the lowest pain level is evaluated as '0' and the highest pain level is evaluated as '10'. As the level of pain increases, the intensity of the pain increases numerically and is expressed by facial expression.
Measured: immediately before starting the process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DistressStudies 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
- Model description
- Two groups with traditional therapy control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karakaya, Uskudar University
- Investigators
- Tuğba KARAKUŞ TÜRKER, Study director, Üsküdar University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886828
- Sponsor's protocol ID
- UskudarU-SBE-TK-01
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I'll share it if necessary, I'm not thinking about it now.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Application During High Flow Nasal Oxygen Therapy in Children Effect on Anxiety Levels: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06886828
- Acronym / sponsor ID
- UskudarU-SBE-TK-01
- Conditions
- Respiratory Distress
- Keywords
- high flow nasal oxygen therapy, virtual reality, Anxiety, distraction of attention, child
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 20 Mar 2025 (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.
Determination of the effect of virtual reality goggles used during high-flow oxygen therapy on child anxiety in children
Detailed description
Respiratory system diseases are frequently seen in childhood and hospitalised constitute a significant portion of the applications. Children continue their treatment in paediatric clinics or intensive care units according to their clinical conditions. In paediatric intensive care units, patients need respiratory support at various rates and respiratory support therapies are among the most commonly used treatment methods in paediatric intensive care clinics. Oxygen given to the appropriate patient under appropriate conditions treatment accelerates the healing process of the disease and prevents the progression of the current situation in a bad course and reduces mortality and morbidity. Oxygen therapy in hospitalised children invasive or non-invasive methods. Invasive method is the treatment method in which endotracheal intubation and mechanical ventilator are used. Noninvasive oxygen therapies are basically analysed in two groups as low-flow and high-flow applications. Low flow oxygen therapy is applied with nasal cannula, hood and tent system, simple face mask, reservoir mask and diffuser mask. High-flow oxygen systems include venturi mask, continuous positive airway pressure (cpap) therapy, bi-level positive airway pressure (bipap) therapy and high-flow nasal cannula oxygen therapy (HFNC). HFNC therapy is a non-invasive form of respiratory support that allows the delivery of high flow (30-60 L/min) of humidified and heated air (31 to 37°C) at a certain oxygen concentration (21-100%) through a nasal cannula, which can be used in the treatment of acute and chronic diseases with values appropriate to the patient's age/body weight and needs. Compared to normal nasal cannula and face mask, HFNC provides a higher level of respiratory support.
can happen. Children experience discomfort and anxiety due to the pressure created by the flow rate and the sound made by the device, and discomfort from the nasal cannula causes resistance to treatment. Nurses are responsible for implementing HFNC, observing the effectiveness of the treatment, monitoring children during HFNC and maintaining their daily life activities, and in this process, they benefit from evidence-based nursing practices. Medical procedures encountered during hospitalisation are the main source of fear for children. They may experience anger, helplessness and anxiety due to reasons such as unfamiliar environment, change in the routine of the child, different sound, light, tools and equipment, unfamiliar people, painful painful procedures, being away from family and friends, loss of control, activity limitation, communication difficulties, presence of other children crying. The use of technology in preparation for or during medical procedures is an effective method in providing anxiety and comfort. At the same time, respiratory distress experienced by children causes anxiety, dyspnoea and increased respiratory rate. In addition to the provision of effective respiratory support, it is important to improve children's experience of the hospital process and In order to support long-term physical and psychosocial health, it is necessary to utilise distraction methods for anxiety management. Nurses is independently involved in the management of oxygen therapy to prevent and protect patients from the adverse effects of hypoxaemia. Distraction methods, atraumatic care It is one of the non-pharmacological methods among the approaches and is used to control pain, stress and anxiety. There are many methods used to divert attention.
Some of them are; watching cartoons, hypnotherapy, playing with toys, using virtual reality, music therapy, play therapy, using kaleidoscope and using distraction cards. This study was planned to determine the effect of virtual reality used during high flow nasal cannula oxygen therapy on physiological parameters and anxiety levels in children aged 6-12 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with traditional therapy control group.
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Device: Virtual reality goggles during HFNCPre-Procedure: Information about the study will be given. Children with a pain score of '0' will be included in the groups. Verbal and written consent will be obtained from those who voluntarily agree to participate in the study. Video recording will be started with a mobile phone. Physiological parameters and anxiety level of the children will be measured and recorded 1 minute before the treatment. HFNC oxygen therapy will be started with video demonstration accompanied by virtual reality glasses. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the study, only the behaviours of the child during the procedure should be video recorded by means of a mobile phone. For participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated ins |
| routine procedure | Active comparator | Device: HFNC oxygen therapy with routine service applicationInformation about the study will be given. Children with a pain score of '0' will be included in the groups. Verbal and written consent will be obtained from those who voluntarily agree to participate in the study. Video recording will be started with a mobile phone. Physiological parameters and anxiety level of children will be measured and recorded 1 minute before the treatment. HFNC oxygen therapy will be started with routine ward practice. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the research, only the behaviours of the child during the procedure should be video-recorded by means of a mobile phone. For participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated instantly by a researcher independent from the study. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The child is between 6-12 years old
- The child is receiving high flow nasal cannula oxygen therapy in the paediatric intensive care unit
- The child has no visual and hearing problems
- No pain according to the Wong-Baker pain scale
- No genetic, congenital, chronic or metabolic disease
Key exclusion criteria (5 listed)
- The child is in pain.
- The child is taking a sedative medication
- The child has a fever above 37°C
- The child presented with a severe asthma attack
- The child's saturation value was below 92% at the time of admission
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 |
|---|---|---|
| Virtual reality goggles during HFNCHFNC oxygen therapy will be started with video demonstration accompanied by virtual reality glasses. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the study, only the behaviours of the child during the procedure should be video recorded by a mobile phone. For the participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated instantly by a researcher independent from the study. The study will continue until the 30-person intervention group is completed. | Device | virtual reality |
| HFNC oxygen therapy with routine service applicationHFNC oxygen therapy will be started with routine ward practice. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the research, only the behaviours of the child during the procedure should be video-recorded by means of a mobile phone. For participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated instantly by a researcher independent from the study | Device | routine procedure |
Primary outcome
Children's Emotional Manifestation Scale-CEMS
Time frame: 1 minute before the start of the procedure and 1 minute after 10 minutes of VR viewing
It was developed in 2003 by William Li and Lopez to assess the level of anxiety in children aged 7-12 years. The Turkish validity and reliability of the scale was carried out by Yanık et al. in 2019 with the approval and opinion of William Li and Lopez on the appropriateness of evaluating anxiety in children aged 3-6 years. The scale has 5 different categories and 25 items and is used to assess the anxiety level of children aged 3-12 years during medical interventions. In the facial expression category, the facial expressions of the child are evaluated by the researcher. In the vocalisation category, tear status is evaluated. In the movement category, the child's body language is evaluated. In the interaction category, the child's verbal/non-verbal communication status is evaluated. In the cooperation category, the child's active / passive participation is evaluated. Each category is between 1-5 points and a total score between 5-25 points is obtained. Cronbach's Alpha value is 0.969.
1 secondary outcome
Wong and Baker Faces Pain Scale
Time frame: immediately before starting the process
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No. I'll share it if necessary, I'm not thinking about it now.
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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.
Tuğba KARAKUŞ TÜRKER study director
Üsküdar University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality goggles during HFNC and HFNC oxygen therapy with routine service application in people with Respiratory Distress, run by Uskudar University 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba KARAKAYA (+905435701207, tuggbbakarakaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Emotional Manifestation Scale-CEMS (time frame: 1 minute before the start of the procedure and 1 minute after 10 minutes of VR viewing). 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 26 Mar 2025.