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Completed

NCT Number: NCT05818761

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Anxiety Disorders Anxiety State Fear Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

wearing virtual reality glasses

stress ball

Behavioral

squeezing the stress ball during the attempt

Primary outcomes

  1. Pain assesed by Wong-Baker FACES

    Time frame: up to 5 minutes after the phelobotomy

    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).

  2. Anxiety assesed by Children Anxiety Meter-State

    Time frame: up to 5 minutes after the phelobotomy

    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

  3. Fear assesed by Child Fear Scale

    Time frame: up to 5 minutes after the phelobotomy

    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.

Secondary outcomes

  1. Emotional Appearance

    Time frame: up to 5 minutes after the phelobotomy

    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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Acronym: VR-DEU22

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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