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CompletedNCT05588687Updated Apr 11, 2023

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

An interventional study of Virtual reality and Tablet in Pain, Anxiety and Fear, sponsored by Trakya University. Completed at 1 site in Turkey. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Trakya University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2022, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Pain
  • Anxiety
  • Fear
  • Venipuncture Site Reaction
  • Nursing Caries

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 159 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Trakya University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • No intervention
    Control group

    Children in the control group will be received standard care. Control group children will not receive any distraction techniques.

  • Experimental
    Virtual reality group

    The children in the VR groups will watch the video by wearing virtual glasses during the blood draw. By wearing the VR headsets in the VR-Rollercoaster Group, will watch Ice Age.

    Behavioral: Virtual reality

  • Experimental
    Tablet group

    The children in the tablet groups will watch the video during the blood draw with tablet. They will watch Ice Age.

    Device: Tablet

Interventions

  • BehavioralVirtual reality

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

  • DeviceTablet

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

06

What researchers measure

Primary outcomes

  1. 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). 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.

    Time frame: 1 minute before the blood draw procedure

  2. 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). 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.

    Time frame: 1 minute after the blood draw procedure

  3. Procedure Related Fear

    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.

    Time frame: 1 minute before the blood draw procedure

  4. Procedure Related Fear

    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.

    Time frame: 1 minute after the blood draw procedure

  5. Procedure Related Anxiety

    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.

    Time frame: 1 minute before the blood draw procedure

  6. Procedure Related Anxiety

    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.

    Time frame: 1 minute after the blood draw procedure

07

Study locations

1 site
  • Remziye Semerci
    Edirne, Center 22030, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05588687
Lead sponsor
Trakya University
Responsible party
Remziye Semerci (Assistant Professor, Trakya University) — Principal investigator
First posted
Oct 20, 2022
Start date
Feb 1, 2022
Primary completion
May 1, 2022
Completion
Jun 1, 2022
Last update
Apr 11, 2023

Study contacts

Remziye Semerci, PhD
principal investigator · Koç University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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