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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05588687
• Other study ID #: Koç University
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2023
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

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

Locations

Country	Name	City	State
Turkey	Remziye Semerci	Edirne	Center

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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