Clinical trial NCT05818761: Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Official title: The Effects of Virtual Reality and Stress Ball Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Fear
Anxiety State
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assesed by Wong-Baker FACES
timeFrame: up to 5 minutes after the phelobotomy
measure: Anxiety assesed by Children Anxiety Meter-State
timeFrame: up to 5 minutes after the phelobotomy
measure: Fear assesed by Child Fear Scale
timeFrame: up to 5 minutes after the phelobotomy
Secondary outcomes:
measure: Emotional Appearance
timeFrame: up to 5 minutes after the phelobotomy
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Gülçin Özalp Gerçeker, pHD
role: PRINCIPAL_INVESTIGATOR
References: