Virtual Reality Application During High Flow Nasal Oxygen Therapy in Children Effect on Anxiety Levels

NCT ID: NCT06886828

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-04-30

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.

Conditions

Respiratory Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

virtual reality

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

Group Type: EXPERIMENTAL

Virtual reality goggles during HFNC

Intervention Type: DEVICE

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.

routine 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 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.

Group Type: ACTIVE_COMPARATOR

HFNC oxygen therapy with routine service application

Intervention Type: DEVICE

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

Interventions

Virtual reality goggles during HFNC

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.

Intervention Type: DEVICE

HFNC oxygen therapy with routine service application

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

Tuğba Karakaya

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuğba KARAKUŞ TÜRKER

Role: STUDY_DIRECTOR

Üsküdar University Faculty of Health Sciences

Locations

Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital

Istanbul, Sancaktepe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Tuğba KARAKAYA

Role: CONTACT

tuggbbakarakaya@gmail.com

+905435701207

Facility Contacts

İlhan Varank Sancaktepe Training and Research Hospital Training and Research Hospital

Role: primary

istanbuleah35.bsh@saglik.gov.tr

+902166063300

Other Identifiers

UskudarU-SBE-TK-01

Identifier Type: -

Identifier Source: org_study_id