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

NCT05588687 | Completed

• 1 other identifier: Koç University
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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.

  1 minute before the blood draw procedure

• 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.

  1 minute after the blood draw procedure

• 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.

  1 minute before the blood draw procedure

• 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.

  1 minute after the blood draw procedure

• 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.

  1 minute before the blood draw procedure

• 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.

  1 minute after the blood draw procedure

Study Arms (3)

Control group

NO INTERVENTION

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

Virtual reality group

EXPERIMENTAL

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

Tablet group

EXPERIMENTAL

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

Device: Tablet

Interventions

Virtual reality BEHAVIORAL

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

Virtual reality group

Tablet DEVICE

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

Tablet group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Remziye Semerci

Edirne, Center, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Remziye Semerci, PhD

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is an experimental, parallel-group (intervention-control), randomized controlled design

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: October 20, 2022
• Study Start: February 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)