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

NCT06893237 | Not Yet Recruiting

• 1 other identifier: UskudarU-SBE-TK-02
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Respiratory Infections, Acute; Respiratory Tract Diseases

Keywords

inhalation therapy; child; virtual reality glasses; anxiety; distraction of attention

Outcome Measures

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.

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

Study Arms (3)

virtual reality group

EXPERIMENTAL

Video recording will be started after the consent is obtained. Physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety of the child will be measured and recorded 1 minute before the procedure. 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.

Other: virtual reality goggles and inhalation treatment

group of distraction cards

EXPERIMENTAL

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 shown the distraction cards and inhalation treatment will be started simultaneously. Playing with the distraction cards will continue for 10 minutes until the end of inhalation treatment. Then, the use of toys will be terminated and the child's physiological parameters and anxiety will be recorded after 1 minute. Video recording will be terminated. For participants who want to participate in the study but do not consent to be video recorded, the evaluations will be carried out by a nurse independent of the study.

Other: distraction cards and inhalation therapy

control group

ACTIVE COMPARATOR

Video recording will be started after the consent is obtained. Physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety of the child will be measured and recorded 1 minute before the procedure. Then, inhalation treatment will be started with routine service practice. The child will receive inhalation treatment for 10 minutes. Physiological parameters and anxiety will be measured and recorded again 1 minute after the procedure. Video recording will be terminated. 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.

Other: inhalation therapy

Interventions

virtual reality goggles and inhalation treatment OTHER

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.

virtual reality group

distraction cards and inhalation therapy OTHER

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.

group of distraction cards

inhalation therapy OTHER

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.

control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• After being informed, the child and parent agree to participate in the study in writing and verbally
• No genetic, congenital, chronic or metabolic disease
• The child has no signs of respiratory failure

You may not qualify if:

• 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,
• The child's saturation value is below 92% at the time of application.

Sponsors & Collaborators

• Uskudar University: lead

MeSH Terms

Conditions

Respiratory Tract Infections; Respiratory Tract Diseases; Anxiety Disorders

Interventions

Respiratory Therapy

Condition Hierarchy (Ancestors)

Infections; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: three groups with traditional therapy control group.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share