Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients

Study Overview
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Brief Summary
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In this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology outpatient clinic.

Detailed Description
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This prospective randomized controlled study was conducted in the pediatric hematology and oncology polyclinic blood collection unit of a university hospital in Turkey. Patients undergoing phelobotomy were allocated to virtual reality or control groups according to a stratified randomization scheme.

Official Title
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Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients

Conditions
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Virtual Reality, Pain, Acute, Pediatric Cancer

Intervention / Treatment
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* Behavioral: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the age range is between 4-12 to apply to the pediatric hematology and oncology outpatient clinic and to have blood taken consent of the child and parent to voluntarily participate in the study The child does not have a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality. Exclusion Criteria: having a fever (>37.5C) and severe dehydration Before the invasive procedure, the patient was given anagesics.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality<br>In the study, Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used, and the Epic Roller Coasters train game, an application that would attract the attention of children, was determined by the researchers. The virtual reality application was started 2 minutes before the procedure and continued until the procedure was completed. | Behavioral: Virtual Reality<br>* Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used in the study.<br>|
| No Intervention: control<br>The child in the control group did not receive any additional intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assesed by Wong-Baker FACES | Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10 | procedure - during the phelobotomy | 
| Fear assesed by Child Fear Scale | The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. | procedure -during the phelobotomy | 
| Anxiety assesed by Children Anxiety Meter-State | 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). | procedure- during the phelobotomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emotional apperance assesed by Emotional Appearance Scale for Children | 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. | Baseline - before the phelobotomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, phlebotomy, pain, fear, anxiety, emotional apperance