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Completed

NCT Number: NCT05588687

The Effect of Two Distraction Methods on the Level of Pain, Fear and Anxiety in Children

The aim of this study is to determine the effect of watching cartoons with virtual reality glasses and tablets applied during the blood collection process on the level of pain, fear and anxiety experienced by children.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Fear Mental Disorders Neurologic Manifestations Nursing Caries Pathological Conditions, Signs and Symptoms Signs and Symptoms Venipuncture Site Reaction

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Remziye Semerci

Edirne, Center, 22030, Turkey (Türkiye)

About this study

Needle procedures applied to children for diagnosis and treatment cause fear, anxiety, and pain. In cases where children's pain and fear cannot be controlled, health professionals and parents may experience feelings of stress, helplessness, and guilt. Many approaches reduce pain and anxiety in children during painful procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. There are many methods used to divert attention. Some of those; watching cartoons, inflating balloons, creating balloons by blowing foam, directing techniques, parent coaching, using virtual reality (VR) glasses, listening to music, kaleidoscope, and using distraction cards. The research is a randomized controlled experimental study designed to determine the effects of two different methods (watching 360-degree cartoons with virtual reality glasses and watching cartoons with a tablet) during the blood collection procedure in children, on the level of pain, fear, and anxiety experienced by children.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The child and family agree to participate in the research,
  • The child is between the ages of 5-12
  • The child does not have a chronic and mental health problem.
  • Not having a visual and hearing disability
  • No history of sedative, analgesic or narcotic substance use within 24 hours before admission
  • Not having a febrile illness at the time of application
  • Absence of a disease causing chronic pain
  • Being treated in the green area according to the 3-level (red-yellow-green) triage system.
  • Performing the operation at once

Exclusion criteria

  • • The child and family's refusal to participate in the research
  • Having a visual and auditory problem
  • The child is less than 5 years old or older than 12 years old
  • The child has a chronic and mental health problem
  • Being treated in the red or yellow area according to the 3-level (red-yellow-green) triage system.

Treatment and study plan

Virtual reality

Behavioral

Children will watch Ice Age in virtual reality during blood draw and the researcher will monitor their pain, anxiety and fear.

Tablet

Device

Children will watch Ice Age with a tablet during blood draw and the researcher will monitor their pain, anxiety and fear.

Primary outcomes

  1. Pain assesed by Wong-Baker FACES

    Time frame: 1 minute before the blood draw procedure

    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). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.

  2. Pain assesed by Wong-Baker FACES

    Time frame: 1 minute after the blood draw procedure

    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). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.

  3. Procedure Related Fear

    Time frame: 1 minute before the blood draw procedure

    The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.

  4. Procedure Related Fear

    Time frame: 1 minute after the blood draw procedure

    The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.

  5. Procedure Related Anxiety

    Time frame: 1 minute before the blood draw procedure

    The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.

  6. Procedure Related Anxiety

    Time frame: 1 minute after the blood draw procedure

    The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

The Effect of Two Different Distraction Methods Applied During Venous Blood Collection Procedure on the Level of Pain, Fear and Anxiety in Pediatric Emergency Department

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2022
Registry last updated
Apr 11, 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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