Taichung Veterans' General Hospital
Taichung, 407219, Taiwan
Location status: Recruiting
NCT Number: NCT06489353
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.
Interested in participating?
Request Info3 year–6 year
All sexes
Interventional
Not applicable
Taichung, 407219, Taiwan
Location status: Recruiting
The goal of this clinical trial is to explore the effectiveness of watching videos and blowing paper pinwheels in reducing pain and fear in children undergoing venipuncture in children aged 3-6 years hospitalized for the first time and undergoing intravenous infusion or blood draw. The main questions it aims to answer are:
If there is a comparison group: Researchers will compare the group of children watching videos and the group of children blowing paper pinwheels to the control group receiving standard care to see if these interventions are effective in reducing pain and fear during venipuncture.
Participants will:
Interventions:
Participants will be randomly assigned to one of three groups:
Outcome Measures
The effectiveness of the interventions will be measured using the following tools
Study Design
This study will be conducted at the 66th Ward of Taichung Veterans General Hospital. After obtaining informed consent from parents and assent from children, participants will be randomly assigned to one of the three groups using a random number generator. The nurse performing the venipuncture will be blinded to the group assignment. Data will be collected by research personnel not involved in the data collection process.
Statistical Analysis
Descriptive statistics will include frequencies, means, and standard deviations. Inferential statistics will be conducted using ANOVA to determine the significance of the differences between groups.
Expected Outcomes
The study expects that children in the intervention groups (video watching and paper pinwheel blowing) will have lower pain and fear scores, and their parents will have lower anxiety scores and higher satisfaction compared to the control group. This research aims to improve the quality of care for hospitalized children undergoing venipuncture.
Handling of Adverse Reactions
If participants experience dizziness or discomfort during the intervention, the procedure will be stopped immediately, and necessary assistance will be provided.
Funding and Compensation
The study is funded by the Taichung Veterans General Hospital internal research project (project number: TCVGH-1137404B). Any adverse reactions caused by the study will be covered by the hospital, excluding anticipated side effects listed in the informed consent form.
Conflict of Interest There are no potential conflicts of interest associated with this study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will watch age-appropriate and engaging videos.
Participants will blow pinwheels during the venipuncture procedure
Time frame: Assessed immediately before and after the venipuncture.
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.
Time frame: Assessed immediately before and after the venipuncture procedure.
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.
Time frame: Assessed immediately before and after the venipuncture procedure.
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.
Time frame: Assessed immediately after the child's venipuncture procedure.
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.
Time frame: Assessed immediately after the child's venipuncture procedure.
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.
Contact information is provided by the study sponsor or research team.
Taichung Veterans General Hospital
Other
The Effect of Watching Video and Blowing Paper Pinwheels on Pain and Fear in Children Undergoing Venipuncture.
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