Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children

Study Overview
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Brief Summary
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This randomized controlled study was planned to evaluate the effects of distraction methods, using virtual reality or a stress ball, on the emotional appearance, pain, fear, and anxiety associated with the procedure, during the phlebotomy in children aged 6-12 in a private blood collection unit.

Detailed Description
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H1: There is a difference between the groups in terms of pain, fear, anxiety and emotional appearance scores related to the intervention during the blood draw attempt. A standard approach will be applied to all children. Standard approach; giving information about the procedure, the nurse introducing herself, choosing the area together, being with the parent and talking to the child during the procedure, I'm starting now, I'm cleaning the area, take a deep breath, I'm applying it now, it may hurt a little, you shouldn't move, it will take a very short time, I will cover it with tape  contains. In the virtual reality glasses group, a tourniquet will be attached to the extremity where the intervention will be performed. By wearing virtual glasses, the video will be started. In the stress ball group, before the intervention is applied, the other hand will be given a stress ball and asked to squeeze it. In the control group, communication with the child will continue during the intervention with the questions mentioned above. When the nurse decides on the area where the PICT will be performed (the minute will be recorded), she will use the words I am cleaning the area, take a deep breath, now I am applying the injection, it may hurt a little, you should not move, it will be very short. The intervention will be stopped when the blood draw attempt fails in all groups. 5 minutes after the blood draw attempt, the child will be asked to rate the most painful moment felt during the procedure using the Facial Expressions Rating Scale. The Child Fear Scale (CDS) and Child Anxiety Scale-State (CAS-D) will be given to the child to assess how anxious and frightened he is during the procedure. The child will be asked to mark with a pencil. The Emotional Appearance Scale for Children will be evaluated by the nurse after the procedure.

Official Title
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The Effects of Virtual Reality and Stress Ball Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children

Conditions
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Pain, Acute, Fear, Anxiety State

Intervention / Treatment
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* Device: virtual reality
* Behavioral: stress ball


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age range of children is between 6-12 The child's consent to voluntarily participate in the study Parent's willingness to participate in the study voluntarily Obtaining consent forms from child and parent Exclusion Criteria: The child has a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality. fever (>37.5C) and severe dehydration The child takes analgesics before the blood draw Wearing glasses

Ages Eligible for Study
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Minimum Age: 6 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
Interventional Model Description: Randomised
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality<br>watching the application by wearing virtual glasses to the child during the phlebotomy | Device: virtual reality<br>* wearing virtual reality glasses<br>|
| Experimental: Stress ball<br>a stress ball will be given to the child's hand, and he will be asked to squeeze continuously before the blood draw attempt begins, and to continue squeezing during the procedure. | Behavioral: stress ball<br>* squeezing the stress ball during the attempt<br>|
| No Intervention: control<br>standard approach | |

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. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). | up to 5 minutes after 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). This scale ranges from 0 to 10. Higher values represent higher anxiety | up to 5 minutes after the phelobotomy | 
| Fear assesed by Child Fear Scale | 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. It can be used during the procedure for children aged 5-10 years. | up to 5 minutes after the phelobotomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Appearance | Emotional Appearance Scale for Children will use. 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. | up to 5 minutes after the phelobotomy |