The Effect of Virtual Reality Goggles and Distraction Cards Applied to Children Aged 6-12 Years During Inhaler Therapy on Physiological Parameters and Anxiety

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

About this trial

In the literature, studies examining the effect of virtual reality application on physiological parameters and anxiety during inhalation therapy, which is frequently used in children, are quite limited. Therefore, this study will be conducted to determine the effect of virtual reality goggles and distraction cards on physiological parameters and anxiety in patients receiving inhalation therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The child is receiving inhalation (salbutamol) treatment in the pediatric intensive care unit.

The child must be between 6-12 years old

The child must not have any vision or hearing problems.

Being conscious and being able to communicate verbally

Disqualifiers

The child's clinical treatment is due to a history of surgery,

The child is taking a sedative medication,

The child has a fever over 37°C,

The child has applied with a severe asthma attack,

Trial design

Design model

Parallel

Treatments tested in this trial

  • virtual reality goggles and inhalation treatment

    Other intervention

    Video recording will be started after the consent is obtained. One minute before the procedure, the child's physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, the child will be fitted with virtual reality goggles and inhalation treatment will be started by watching the aquarium and sea creatures video. Inhalation treatment will last for 10 minutes with the most appropriate air flow rate of 6-8 L/min. Then, the virtual reality goggles will be removed and the child's physiological parameters and anxiety will be measured and recorded again after 1 minute. For participants who want to participate in the study but do not approve the video recording, the evaluations will be made by a nurse independent of the study.

  • distraction cards and inhalation therapy

    Other intervention

    After the consent is obtained, the video recording will be started. 1 minute before the procedure, the child's physical parameters (heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, the child will be shown distraction cards and inhalation therapy will be started simultaneously. Playing with the distraction cards will continue for 10 minutes until the end of the inhalation therapy. Then, the use of the toys will be stopped and the child's physiological parameters and anxiety will be recorded after 1 minute. The video recording will be ended. For participants who want to participate in the study but do not consent to being video recorded, the evaluations will be made by a nurse independent of the study.

  • inhalation therapy

    Other intervention

    After the consent is received, the video recording will be started. 1 minute before the procedure, the child's physical parameters (heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, inhalation therapy will be started with routine service application. The child will receive inhalation therapy for 10 minutes. 1 minute after the procedure, physiological parameters and anxiety will be measured and recorded again. The video recording will be ended. For participants who want to participate in the study but do not approve of being video recorded, evaluations will be made by a nurse independent of the study.

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: virtual reality groupExperimental treatment 1 intervention
Group B: group of distraction cardsExperimental treatment 1 intervention
Group C: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Children's Emotional Manifestation Scale-CEMS

This scale was developed by William Li and Lopez in 2003 to assess the anxiety level in children aged 7-12. The Turkish validity and reliability of the scale was conducted by Yanık et al. in 2019, after receiving the approval and opinion of William Li and Lopez regarding the suitability of assessing anxiety in children aged 3-6. The scale has 5 different categories and 25 items and is used to assess the anxiety level of children aged 3-12 during medical interventions. The child's facial expressions are assessed in the facial expression category. Tears are assessed in the vocalization category. Evaluation is made according to the child's body language in the movement category. The child's verbal/nonverbal communication is assessed in the interaction category. The child's active/passive participation is assessed in the cooperation category. Each category is between 1-5 points and a total score of 5-25 points is obtained.

Time frame
1 minute before and 10 minutes after the start of the procedure and for approximately 1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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