The Effect of Non-pharmacological Methods on Pain, Fear

Summary

This randomized controlled experimental study aims to evaluate the effectiveness of guided imagery and virtual reality (VR) in reducing pain and fear in children during blood draw procedures. The sample will consist of children aged 8-14 who meet the inclusion criteria and present to the Koç Hospital Pediatric Clinic Blood Drawing Room. After informing the children and their parents about the study, written and verbal consents will be obtained. Participants will then be randomly assigned into one of three groups-two experimental (guided imagery and VR) and one control-using a random number list generated via Excel.

Pre-procedure: Prior to the intervention, children and parents will be informed using consent forms. Demographic and baseline data will be collected using the Child Patient Introductory Information Form. Pain will be assessed with the Faces Pain Scale-Revised (FPS-R) by the child and the Visual Analog Scale (VAS) by the parent and observer. Fear will be evaluated using the Children's Fear Scale (CFS), self-rated by the child and assessed by the parent/observer. A pulse oximeter will be attached to measure baseline pulse and oxygen saturation (SpO2) levels starting 1 minute before the procedure.

Guided Imagery Group: Children will listen to an audio recording titled "A Walk in the Forest" using headphones. They will be instructed to close their eyes and imagine the scene described, focusing on the sound to facilitate distraction. The audio will start 1 minute prior to the procedure.

Virtual Reality Group: Children in this group will wear VR glasses and watch an immersive AI-generated video of "A Walk in the Forest." This aims to provide a more interactive distraction during the blood draw.

Control Group: Children will undergo routine blood draw procedures with no additional distraction techniques. The procedure will be explained as usual.

Procedure: A trained nurse will perform all blood draws. During the procedure, SpO2 and pulse data will be recorded. Post-procedure, these will also be documented immediately and 1 minute after the intervention.

Post-procedure: After the procedure, FPS-R and CFS will be used again by children to assess pain and fear. Parents and observers will complete VAS and CFS to evaluate observed pain and fear. Headphones or VR glasses will be removed following the final measurement.

Conditions

• Children
• Pain
• Fear
• Pediatric ALL

Interventions

PROCEDURE

Virtual reality, guided imagery

Before the procedure, children will be informed via the Child Consent Form, and parents through the Informed Consent Form. Verbal and written consents will be obtained, and data will be recorded in the Child Patient Introductory Information Form. Pre-procedural pain will be assessed using the Faces Pain Scale-Revised scale, and the child will mark their pain. Parents will use the VAS scale for pain assessment. The CFS scale will be explained to both the child and parent to assess the child's fear. A pulse oximeter will measure SPO2 and pulse one minute before the procedure. The blood collection procedure will be performed by an experienced nurse, and heart rate and oxygen saturation will be recorded in the Application Record Form. After the procedure, measurements will be taken immediately after the procedure and one minute later. Children will mark their pain and fear levels on the FPS-R and CFS scales. Parents and observers will also assess the child's pain (VAS) and fear (CFS).

Sponsors & Collaborators

• Fenerbahce University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-10

Primary Completion

2026-08-28

Completion

2026-09-14

Countries

• Turkey (Türkiye)

Study Locations