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NCT07032181

The Effect of Non-pharmacological Methods on Pain, Fear

Not yet recruiting NA Last updated 22 June 2025
What this trial tests

NA trial testing Virtual reality, guided imagery in Children in 93 participants. Not yet recruiting.

Timeline
10 September 2025
Primary endpoint
28 August 2026
14 September 2026

Quick facts

Lead sponsorFenerbahce University
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment93
Start date10 September 2025
Primary completion28 August 2026
Estimated completion14 September 2026
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Fenerbahce University

Who can join

Adults 8 to 14, any sex, with Children or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07032181.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing