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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUskudar University

About this trial

Determination of the effect of virtual reality goggles used during high-flow oxygen therapy on child anxiety in children

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality goggles during HFNC

    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.

  • HFNC oxygen therapy with routine service application

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: virtual realityExperimental treatment 1 intervention
Group B: routine procedureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
immediately before starting the process

Other outcomes

Sponsors and contacts

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