Distraction Methods for Reducing Pain and Fear During Blood Draw in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorGülsev Kutman
About this trial
Blood draw is a common invasive procedure that can cause pain and fear in children. This randomized controlled trial aims to compare the effects of pinwheel blowing, 3D hologram viewing, and sugar-free gum chewing on pain and fear during blood draw among children aged 5-10 years. Parental satisfaction with the care provided during the procedure will also be evaluated.
A total of 164 children will be assigned in a 1:1:1:1 ratio to the pinwheel blowing, 3D hologram viewing, gum chewing, or control group using block randomization stratified by age and sex. The interventions will begin one minute before the blood draw and continue until the procedure is completed. Children in the control group will receive the routine blood draw procedure without any additional nonpharmacological intervention.
Immediately after the blood draw, the child's pain and fear during the procedure will be independently evaluated by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will also be assessed after the procedure.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 5 to 10 years
Scheduled to undergo a blood draw
No analgesic medication use within 6 hours before the procedure
No visual, hearing, or speech impairment
Disqualifiers
Previous history of syncope during blood draw procedures
Blood draw not completed on the first attempt
Development of syncope during the procedure
Inability or unwillingness to complete the assigned intervention
Trial design
Design model
Parallel
Treatments tested in this trial
3D Hologram Viewing
BehavioralChildren will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The holographic display will be positioned approximately 50 cm from the child. The intervention will begin one minute before the blood draw and continue until the procedure is completed.
Pinwheel Blowing
BehavioralChildren blow a colorful handheld pinwheel with a diameter of 16 cm. The intervention begins one minute before the blood draw and continues until the procedure is completed. Children hold the pinwheel with the hand not used for blood collection; the researcher holds it when necessary.
Gum Chewing
BehavioralChildren will select a 14.5-g piece of sugar-free flavored gum and begin chewing it one minute before the blood draw. The available flavors will include watermelon, strawberry, orange, and mixed fruit. Children will continue chewing the gum until the procedure is completed.
Treatment groups
164 Participants
are divided into 4 treatment groupsGroup A: 3D Hologram Viewing GroupExperimental treatment 1 intervention
Group B: Pinwheel Blowing GroupExperimental treatment 1 intervention
Group C: Gum Chewing GroupExperimental treatment 1 intervention
Group D: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Child-Reported Pain Intensity During Blood Draw Assessed Using the Wong-Baker FACES Pain Rating Scale
Pain experienced during the blood draw will be assessed by the child using the Wong-Baker FACES Pain Rating Scale. The scale consists of six faces scored as 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Time frame
Immediately after the blood draw, within approximately 5 minutes2
Child-Reported Fear During Blood Draw Assessed Using the Children's Fear Scale
Fear experienced during the blood draw will be assessed by the child using the Children's Fear Scale. The scale consists of five facial expressions scored from 0 to 4, where 0 indicates no fear and 4 indicates extreme fear. Higher scores indicate greater fear.
Time frame
Immediately after the blood draw, within approximately 5 minutesSecondary outcomes
1
Parent-Reported Satisfaction With the Blood Draw Procedure
Parental satisfaction with the care provided during the blood draw procedure will be assessed using a single-item numerical rating scale ranging from 1 to 10, where 1 indicates the lowest level of satisfaction and 10 indicates the highest level of satisfaction. Higher scores indicate greater parental satisfaction.
Time frame
Immediately after the blood draw, within approximately 5 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov