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

The Effect of Kaleidoscope and Virtual Reality Glasses on Pain and Anxiety Levels in Venous Blood Collection in Children Aged 9-12

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Child, Only
• Intervention / Treatment: Other: Kaleidoscope; Other: Virtual Reality; Other: control

Detailed Description

After obtaining the necessary institutional permissions, parents and children who come to the blood collection room will be informed about the research through the "Informed Consent Form". The research data will be collected by the researcher using a face-to-face interview technique. Before the blood collection procedure, the children and their families who will be included in the kaleidoscope group, virtual reality group and control group will be informed about the research. 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. The nurse will apply a tourniquet and determine the vein from the antecubital region to be taken from. The blood collection procedure will be taken from the antecubital region by the same nurse in one go using a vakuteynir (vacuum blood collection tube) and blood coming to the Vakuteynir within 5 seconds will indicate that the procedure was successful. This procedure will take approximately 2-3 minutes and the children will watch the kaleidoscope throughout the procedure. After the procedure is completed, the children will be taken out of the blood collection room and taken to the waiting area and the children will be asked to determine the level of pain they felt during the procedure. The child will assess how much fear the child experienced during the blood collection procedure and the level of anxiety.

The child who will be taken into the virtual reality group will be seated in the patient chair and 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. The nurse will perform the tourniquet application and the determination of the vein from the antecubital region from which the blood will be taken. The blood collection procedure will be performed by the same nurse in one go from the antecubital region using a vakutainer (vacuum blood collection tube) and blood coming into the vakutainer within 5 seconds will indicate that the procedure was successful. This procedure will take approximately 2-3 minutes and the children will be shown virtual reality throughout the procedure. After the procedure is completed, the children will be taken out of the blood collection room and taken to the waiting area and the children will be asked to determine the level of pain they felt during the procedure. The child will assess how much fear the child experienced during the blood collection procedure and the level of anxiety they experienced. 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. After the procedure is completed, children will be taken out of the blood collection room and taken to the waiting area. After being allowed to rest for 1-2 minutes, a questionnaire will be administered to the children. The child will evaluate how much fear the child has during the blood collection procedure and what their anxiety is. Children in the control group will not undergo any interventional procedures.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: tuğba oluç, nursing; Phone Number: (0446) 226 6666; Email: tugba.oluc@erzincan.edu.tr
• Study Contact Backup: Name: metin yıldız, nursing; Phone Number: 02642953853; Email: yildizz.metin@gmail.com

Study Locations

• Turkey
  • Sakarya, Turkey
    • To Sakarya University Training and Research Hospital
    • Contact: metin yıldız; Phone Number: 02642953853; Email: yildizz.metin@gmail.com
    • Principal Investigator: TUĞBA OLUÇ, NURSİNG
    • Principal Investigator: METİN YILDIZ, NURSİNG
    • Sub-Investigator: KÜBRA YESİN, MIDWIFERY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Kaleidoscope group; 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; The participation of patients in this group in the study will take approximately 15-20 minutes.
Active Comparator: virtual reality glasses; 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; The participation of patients in this group in the study will take approximately 15-20 minutes.
Other: control group; 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; The participation of patients in this group in the study will take approximately 5-10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wong-Baker Facial Expression Rating Scale (WB-FRS)	measuring fear	1 year
State-Trait Anxiety Inventory for Children	measuring anxiety	1 year

Collaborators and Investigators

• Sponsor: Erzincan Binali Yildirim Universitesi

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Children; Kaleidoscope; Virtual Reality Glasses; PAİN; Venous Blood Collection
• Other Study ID Numbers: EBYU-SBF-TO-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No