The Effect of Watching Video and Blowing Paper Pinwheels in Children
NCT Number: NCT06489353
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Fear
Interventions: BEHAVIORAL: Video-watching|BEHAVIORAL: Blowing Pinwheels
Sponsor: Taichung Veterans General Hospital
Sex: ALL
Age: CHILD
Enrollment: 93
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-12-30

Summary:
The goal of this clinical trial is to evaluate if watching videos and blowing paper pinwheels can reduce pain and fear in children undergoing venipuncture. The participant population includes hospitalized children aged 3-6 years old undergoing venipuncture for the first time.

The main questions it aims to answer are:

1. Does watching videos reduce pain and fear during venipuncture in children?
2. Does blowing paper pinwheels reduce pain and fear during venipuncture in children?

Researchers will compare a group watching videos and a group blowing paper pinwheels to a control group receiving standard care to see if these interventions reduce pain and fear.

Participants will:

* Watch their preferred cartoons on an iPad during the venipuncture process.
* Blow paper pinwheels to distract themselves during the venipuncture process.
* Be accompanied by a family member who will help in holding the child and providing comfort.

Primary Outcome Measures: Wong-Baker Faces Pain Scale (WBFPS) for Children's Self-Reported Pain, The Wong-Baker Faces Pain Scale (WBFPS) is used to measure children's self-reported pain levels. It consists of a series of facial expressions ranging from a smiling face (0) indicating "no pain" to a crying face (10) indicating "worst pain." The child points to the face that best describes their pain., Assessed immediately before and after the venipuncture.|FLACC (Face, Legs, Activity, Cry, Consolability) Behavioral Pain Assessment Scale, The FLACC scale is used to measure pain in children by evaluating five criteria: Face (facial expressions), Legs (movement and positioning), Activity (overall movement and muscle tone), Cry (verbal expressions of pain), and Consolability (the child's ability to be comforted). Each criterion is scored from 0 to 2, with a total score ranging from 0 to 10. Higher scores indicate greater pain severity., Assessed immediately before and after the venipuncture procedure.|Children's Fear Scale (CFS), The Children's Fear Scale (CFS) is used to evaluate the level of fear experienced by children during venipuncture. The scale consists of five facial expressions ranging from a neutral face (0) indicating "no fear" to a very frightened face (4) indicating "high fear." The nurse observes the child's facial expressions and assigns a score based on the child's appearance and behavior during the procedure., Assessed immediately before and after the venipuncture procedure.
Secondary Outcome Measures: Parental State Anxiety Scale (PSAS), The Parental State Anxiety Scale (PSAS) measures the anxiety levels of parents during their child's venipuncture procedure. The scale consists of 20 items, with each item rated on a 4-point scale ranging from 1 (not at all) to 4 (very much). The total score ranges from 20 to 80, with higher scores indicating greater levels of anxiety. The scale assesses the parents' feelings of tension, nervousness, and worry in the specific context of their child's medical procedure., Assessed immediately after the child's venipuncture procedure.|Satisfaction of parents, A 0-10 scale is used to measure family members' satisfaction with the venipuncture process. After the venipuncture procedure, family members fill out this scale, with higher scores indicating greater satisfaction., Assessed immediately after the child's venipuncture procedure.