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

NCT ID: NCT05588687

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-06-01

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: BEHAVIORAL

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

Tablet group

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

Group Type: EXPERIMENTAL

Tablet

Intervention Type: DEVICE

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

Interventions

Virtual reality

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

Intervention Type: BEHAVIORAL

Tablet

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Remziye Semerci

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Remziye Semerci, PhD

Role: PRINCIPAL_INVESTIGATOR

Koç University

Locations

Remziye Semerci

Edirne, Center, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Koç University

Identifier Type: -

Identifier Source: org_study_id