Kaleidoscope Virtual Reality Glasses Pain and Anxiety Levels in Venous Blood Collection Children

NCT06576141 | Not Yet Recruiting

• 1 other identifier: EBYU-SBF-TO-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our research is to investigate the effects of distracting children's attention with a kaleidoscope and virtual reality glasses during venous blood collection on perceived pain and anxiety levels.

Conditions

Child, Only

Keywords

PAİN; Kaleidoscope; Venous Blood Collection; Anxiety; Virtual Reality Glasses; Children

Outcome Measures

Primary Outcomes (2)

• Wong-Baker Facial Expression Rating Scale (WB-FRS)

  measuring fear

  1 year

• State-Trait Anxiety Inventory for Children

  measuring anxiety

  1 year

Study Arms (3)

Kaleidoscope group

ACTIVE COMPARATOR

The kaleidoscope will be used 5 minutes before the blood collection procedure, as the child who will be included in the kaleidoscope group sits in the patient chair. The nurse will start preparing the child for the blood collection procedure at that time.

Other: Kaleidoscope

virtual reality glasses

ACTIVE COMPARATOR

The child to be included in the virtual reality group will be seated in the patient chair and the virtual reality will be used 5 minutes before the blood collection procedure. The nurse will start preparing the child for the blood collection procedure at that time.

Other: Virtual Reality

control group

OTHER

Children in the control group will not undergo any interventional procedures. Blood collection will be arranged to be taken from the antecubital region by the same nurse via a vacutainer.

Other: control

Interventions

Kaleidoscope OTHER

The participation of patients in this group in the study will take approximately 15-20 minutes.

Kaleidoscope group

Virtual Reality OTHER

The participation of patients in this group in the study will take approximately 15-20 minutes.

virtual reality glasses

control OTHER

The participation of patients in this group in the study will take approximately 5-10 minutes.

control group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child must be between the ages of 9-12, The child and parents must agree to participate in the research, The child must be able to communicate and be open to communication, The child must not have any hearing, speech or vision disorders

You may not qualify if:

• The child is not within the age range specified above The child and parents do not agree to participate in the research. The child has a communication problem The child has a hearing, speech or vision disorder.

Sponsors & Collaborators

• Erzincan Binali Yildirim Universitesi: lead

Study Sites (1)

To Sakarya University Training and Research Hospital

Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

tuğba oluç, nursing

CONTACT

(0446) 226 6666; tugba.oluc@erzincan.edu.tr

metin yıldız, nursing

CONTACT

02642953853; yildizz.metin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done via random.org.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: There are three groups. Kaleidoscope ,Virtual Reality Glasses and control group

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)