The Effect of Watching Video and Blowing Paper Pinwheels on Pain and Fear in Children Undergoing Venipuncture.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Children's Fear Scale (CFS)
Study Overview
Brief 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:
- Does watching videos reduce pain and fear during venipuncture in children?
- 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.
Detailed Description
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:
- Does watching videos reduce the pain experienced by children during venipuncture?
- Does blowing paper pinwheels reduce the fear experienced by children during venipuncture?
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:
- Be children aged 3-6 years hospitalized for the first time and undergoing intravenous infusion or blood draw.
- Have no chronic diseases, developmental delays, or epilepsy.
- Have no difficulty speaking, auditory or visual impairments, and have not used sedatives within 6 hours prior to the procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
- Randomization and Allocation: Participants are randomly assigned to one of three groups using a computer-generated table. Group assignments are sealed in opaque envelopes and revealed by a research coordinator not involved in assessments.
- Blinding Care Providers: The nurse is unaware of the group assignment. The coordinator informs the parent and child of the intervention just before the procedure.
- Blinding outcomes assessor: Outcome assessors and data analysts are kept blind to group assignments and only receive anonymized data.
Eligibility Criteria
- Ages
- 3 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged 3-6 years.
- •undergoing intravenous infusion or blood draw during the hospital stay.
Exclusion Criteria
- •chronic diseases.
- •developmental delays or epilepsy.
- •difficulty speaking.
- •hearing or visual impairments.
- •use sedatives within the past 6 hours.
- •history of fainting during intravenous infusion or blood draw.
Arms & Interventions
Video-watching group
Participants will watch age-appropriate and engaging videos during the venipuncture procedure to distract them from pain and fear.
Intervention: Video-watching (Behavioral)
Blowing Pinwheels
Participants will blow pinwheels during the venipuncture procedure, using breathing control and distraction to reduce pain and fear.
Intervention: Blowing Pinwheels (Behavioral)
routine care group
Participants will receive standard routine care during the venipuncture procedure without additional interventions, serving as the control group.
Outcomes
Primary Outcomes
Children's Fear Scale (CFS)
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.
Wong-Baker Faces Pain Scale (WBFPS) for Children's Self-Reported Pain
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.
FLACC (Face, Legs, Activity, Cry, Consolability) Behavioral Pain Assessment Scale
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.
Secondary Outcomes
- Parental State Anxiety Scale (PSAS)(Assessed immediately after the child's venipuncture procedure.)
- Satisfaction of parents(Assessed immediately after the child's venipuncture procedure.)
Investigators
HuiMing Hou
Head Nurse, Department of Nursing
Taichung Veterans General Hospital