The Effect of Non-pharmacological Methods on Pain, Fear

NCT07032181 | Not Yet Recruiting DMC

• 1 other identifier: 2025.167.IRB2.075
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric; Pain; Fear; Children; Blood Sampling

Outcome Measures

Primary Outcomes (2)

• Pain

  The Faces Pain Scale-Revised (FPS-R) is a self-report tool designed to assess acute pain intensity in children aged 4 to 16. It features six facial expressions ranging from neutral (score 0) to severe pain (score 10). Scores of 1-3 indicate mild pain, 4-6 moderate pain, and 7-10 severe pain. The scale is valid, reliable, widely used, and freely available for research or clinical use without special permission. In this study, FPS-R will be used to evaluate children's pain levels before and after injections in both experimental and control groups. The Visual Analogue Scale (VAS), developed in 1921 by Hayes and Patterson, is a 10 cm horizontal line marked from "no pain" to "unbearable pain." Participants mark their pain level on the line, and the pain score is calculated by measuring the distance from the "no pain" end. VAS will be used in this study to measure pre- and post-injection pain levels, as assessed by both parents and the researcher.

  5 minutes before the procedure, 1 minute before the procedure, 1 minute after the procedure, 5 minutes after the procedure

• Fear

  Children's Fear Scale (CFS) The Children's Fear Scale (CFS) is used to measure children's fear and anxiety. In this method, a picture displaying five facial expressions rated from 0 to 4 is shown to the child. A score of 0 indicates no fear or anxiety, while a score of 4 indicates the highest level of fear and anxiety. This scale can be administered by both the researcher and the family to assess fear and anxiety before and during a procedure. In this study, the CFS will be used to evaluate the levels of fear in children from both the experimental and control groups before and after the blood collection procedure.

  5 minutes before the procedure, 1 minute before the procedure, 1 minute after the procedure, 5 minutes after the procedure

Secondary Outcomes (2)

• Heart Rate

  5 minutes before the procedure, one minute before the procedure, During procedure, one minute after the procedure, five minutes after the procedure

• Oxygen Saturation

  5 minutes before the procedure, one minute before the procedure, During procedure, one minute after the procedure, five minutes after the procedure

Study Arms (3)

Guided Imagery

EXPERIMENTAL

To implement the guided imagery method, a text titled "A Walk in the Forest" will be used. The text includes descriptions of living and non-living elements in the forest to help the child imagine taking a walk in a forest. It is designed to engage the child's physical senses through sensory language, encouraging a vivid mental experience.One minute before the blood collection procedure, the child will be given headphones and the audio recording will be started. The prepared text was recorded in a studio with the support of a professional audio recording specialist. The narration was performed by a professional voice actor specializing in voice work, who read the text in a calm and gentle tone. In the background, soft and slow-paced music was played, and nature sound effects-such as bird chirping, rustling leaves, and flowing water-were added at various points to match the flow of the text. The total duration of the audio recording is 2 minutes and 35 seconds.

Procedure: Virtual reality, guided imagery

Virtual Reality

EXPERIMENTAL

Virtual reality (VR) glasses will be used in this study. A video or game compatible with a mobile phone will be loaded onto the device, placed in the front compartment of the VR glasses, and the cover will be closed. The glasses will then be positioned on the child's head. When selecting the VR glasses, attention will be given to choosing lightweight and child-friendly models. In the Virtual Reality Glasses group, unlike the Guided Imagery group, the child will wear VR glasses and watch a video titled "A Walk in the Forest", which was created using artificial intelligence.One minute before the blood collection procedure, the child will be start.

Procedure: Virtual reality, guided imagery

Control

NO INTERVENTION

For the children in the control group, only a routine blood collection procedure will be performed, and they will receive only a standard explanation related to the procedure.

Interventions

Virtual reality, guided imagery PROCEDURE

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).

Guided Imagery; Virtual Reality

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child must be between 8 and 14 years old.
• Both the child and the parent must volunteer to participate in the study.
• The child and the parent must speak Turkish at a native level.
• The child must not have taken any medication with analgesic, antipyretic, or anti-inflammatory effects within the last 6 hours

You may not qualify if:

• The child has visual, hearing, or speech impairments.
• The child is illiterate.
• The child has a clinical condition that prevents the use of VR glasses or headphones.
• The child has an allergy to strawberries (mentioned in the guided imagery script) or a fear of forests or squirrels.
• The child has a disease that may cause chronic pain.
• The child has any auditory, mental, or neurological disability that could affect participation in the study

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Koc University

Istanbul, Zeytinburnu, 0090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Duygu Gözen, Professor

CONTACT

+905327065065; duygugozen@gmail.com

NEGARIN AKBARI

CONTACT

+905352679510; negarin.akbari@fbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): September 14, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)