The Effect of Virtual Reality Goggles and Distraction Cards Applied to Children Aged 6-12 Years During Inhaler Therapy on Physiological Parameters and Anxiety
The Effect of Virtual Reality Goggles and Distraction Cards Applied to Children Aged 6-12 Years During Inhaler Therapy on Physiological Parameters and Anxiety: a Randomised Controlled Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: virtual reality group
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.
|
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.
|
|
Experimental: group of distraction cards
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.
|
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.
|
|
Active Comparator: control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Emotional Manifestation Scale-CEMS
Time Frame: 1 minute before and 10 minutes after the start of the procedure and for approximately 1 year
|
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
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- UskudarU-SBE-TK-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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