The Effects of Virtual Reality on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- procedure related pain
Study Overview
Brief Summary
This randomized controlled study was conducted to evaluate the effect of distraction methods using virtual reality on the emotional appearance, pain, fear, and anxiety associated with the procedure during phlebotomy in children aged 6-12 in a private blood collection unit.
Detailed Description
The data of the study was collected with Socio-demographic Data Collection Form, Emotional Appearance Scale for Children, Facial Expression Rating Scale, Child Anxiety Scale-State, and Child Fear Scale. Demographic data and mean scores obtained from the scales were compared between the virtual reality groups, and the control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Masking Description
Before blood collection, the "Emotional Appreance Scale for Children" was evaluated by a non-researcher nurse. Pediatric patients between the ages of 6 and 12, from whom blood would be collected, were distributed to groups according to the randomization scheme.
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The child agrees to participate in the study voluntarily.
- •The parent agrees to participate in the study voluntarily.
- •Obtaining consent forms from the child and parent
Exclusion Criteria
- •The child has a physical and psychological deficit that will prevent him from wearing the glasses that will be placed on his head to watch virtual reality.
- •Having fever (>37.5C) and severe dehydration
- •The patient did not take analgesics before the intervention
Arms & Interventions
Control
No additional intervention will be performed on the patient in the control group, and until the intervention begins, "How old are you?" Which grade are you in? What is the name of your favorite friend? Which sport do you enjoy doing more? His attention was distracted by asking questions such as.
active Virtual reality
The remote control of the virtual glasses will be given to the hand that will not be interfered with, and the child will start, slow down or stop the application herself. Samsung Gear Oculus Guest 2 headset allows watching virtual reality applications.
Intervention: active virtual reality distraction (Device)
passive virtual reality
It was said that he could watch videos by wearing virtual headset glasses during the procedure. A virtual reality application that will attract the attention of children was determined by the researchers.
Intervention: passive virtual reality distraction (Device)
Outcomes
Primary Outcomes
procedure related pain
Time Frame: 3 minutes after the phlebotomy
Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).
anxiety
Time Frame: 3 minutes before and after the phlebotomy
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety
fear
Time Frame: 3 minutes before and after the phlebotomy
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear.
emotional apperance
Time Frame: 3 minutes before and after the phlebotomy
This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors
Secondary Outcomes
No secondary outcomes reported
Investigators
Gülçin Özalp Gerçeker
Assoc. Prof.
Dokuz Eylul University