Clinical trial NCT06886828: Virtual Reality Application During High Flow Nasal Oxygen Therapy in Children Effect on Anxiety Levels
Official title: Virtual Reality Application During High Flow Nasal Oxygen Therapy in Children Effect on Anxiety Levels: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Distress
Keywords: high flow nasal oxygen therapy
virtual reality
Anxiety
distraction of attention
child
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with traditional therapy control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Children's Emotional Manifestation Scale-CEMS
timeFrame: 1 minute before the start of the procedure and 1 minute after 10 minutes of VR viewing
Secondary outcomes:
measure: Wong and Baker Faces Pain Scale
timeFrame: immediately before starting the process
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital
state: Sancaktepe
Study officials:
affiliation: Üsküdar University Faculty of Health Sciences
name: Tuğba KARAKUŞ TÜRKER
role: STUDY_DIRECTOR
References: