The Effect of Non-pharmacological Methods on Pain, Fear
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-14
SponsorFenerbahce University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual reality, guided imagery
Procedure/SurgeryBefore 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).
Treatment groups
93 Participants
are divided into 3 treatment groupsGroup A: Guided ImageryExperimental treatment 1 intervention
Group B: Virtual RealityExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
5 minutes before the procedure, 1 minute before the procedure, 1 minute after the procedure, 5 minutes after the procedure2
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.
Time frame
5 minutes before the procedure, 1 minute before the procedure, 1 minute after the procedure, 5 minutes after the procedureSecondary outcomes
1
Heart Rate
A finger-type pulse oximeter will be used to measure the children's heart rate values before, during, and after the blood collection procedure. These pulse oximeter devices can measure a child's oxygen saturation and pulse values without the need for invasive procedures.
Time frame
5 minutes before the procedure, one minute before the procedure, During procedure, one minute after the procedure, five minutes after the procedure2
Oxygen Saturation
A finger-type pulse oximeter will be used to measure the children's oxygen saturation values before, during, and after the blood collection procedure. These pulse oximeter devices can measure a child's oxygen saturation and pulse values without the need for invasive procedures.
Time frame
5 minutes before the procedure, one minute before the procedure, During procedure, one minute after the procedure, five minutes after the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: