Fear, Pain Management
Conditions
Keywords
Distraction, 3D Hologram, Gum Chewing
Brief summary
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.
Detailed description
This study is a four-arm, parallel-group randomized controlled trial involving children aged 5-10 years undergoing blood draw in a pediatric phlebotomy unit. The study aims to compare three nonpharmacological methods involving different mechanisms: active distraction through pinwheel blowing, passive visual distraction through 3D hologram viewing, and rhythmic oral and gustatory stimulation through flavored gum chewing. Eligible children will be assigned to the study groups in a 1:1:1:1 ratio using block randomization stratified by sex (female or male) and age group (5-7 or 8-10 years). A block size of four will be used within each stratum. In the pinwheel blowing group, children will begin blowing a colorful handheld pinwheel one minute before the blood draw and continue until the procedure is completed. In the 3D hologram viewing group, children will watch an age-appropriate holographic video featuring colorful flying butterflies, beginning one minute before the blood draw and continuing until the procedure is completed. In the gum chewing group, children will select a flavored sugar-free gum, begin chewing it one minute before the blood draw, and continue throughout the procedure. Children in the control group will receive the routine blood draw procedure without any additional pharmacological or nonpharmacological pain-relieving intervention. The accompanying parent will remain with the child throughout the procedure. All blood draws will be performed by the same nurse, who has at least five years of pediatric phlebotomy experience, using a standardized procedure. Pain experienced during the blood draw will be assessed using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 to 10. Fear will be assessed using the Children's Fear Scale, which ranges from 0 to 4. Immediately after the procedure, pain and fear will be rated independently by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will be evaluated using a single-item numerical rating scale ranging from 1 to 10. Because of the visible nature of the interventions, the children, parents, researcher delivering the interventions, phlebotomy nurse, and observer nurse cannot be blinded to group allocation.
Interventions
BEHAVIORAL3D Hologram Viewing
Children 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.
BEHAVIORALPinwheel Blowing
Children 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.
BEHAVIORALGum Chewing
Children 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.
Sponsors
Gülsev Kutman
Tekirdağ City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Blinding was not possible because the interventions were directly visible to the participants, parents, researcher, phlebotomy nurse, and observer nurse.
Intervention model description
Participants are assigned to one of four parallel study groups: 3D hologram viewing, pinwheel blowing, gum chewing, or control.
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * No neurological disorder * No oral or jaw condition that may prevent gum chewing * No chronic illness requiring frequent invasive procedures * Written informed consent provided by the parent or legal guardian * Verbal assent provided by the children
Exclusion criteria
* 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 * Withdrawal of consent or assent by the parent or child at any stage of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child-Reported Pain Intensity During Blood Draw Assessed Using the Wong-Baker FACES Pain Rating Scale | Immediately after the blood draw, within approximately 5 minutes | 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. |
| Child-Reported Fear During Blood Draw Assessed Using the Children's Fear Scale | Immediately after the blood draw, within approximately 5 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent-Reported Satisfaction With the Blood Draw Procedure | Immediately after the blood draw, within approximately 5 minutes | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTGülsev Kutman, Rn Msc
PRINCIPAL_INVESTIGATORGülsev Kutman
Tekirdağ City Hospital
Outcome results
None listed