The Effect of Watching Video and Blowing Paper Pinwheels in Children

Not Applicable

Recruiting

• Conditions: Pain; Fear
• Interventions: Behavioral: Blowing Pinwheels; Behavioral: Video-watching

• Registration Number: NCT06489353
• Lead Sponsor: Taichung Veterans General Hospital

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:

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.

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.

Interventions:

Participants will be randomly assigned to one of three groups:

1. Video Watching Group:

* Children will choose their preferred cartoon videos.

* They will watch the video on an iPad for 1 minute before and during venipuncture.

* Parents will assist in stabilizing the child and providing comfort during the procedure.

2. Paper Pinwheel Blowing Group:

* Children will select a paper pinwheel of their choice.

* They will practice blowing the pinwheel for 1 minute before the procedure.

* During venipuncture, they will blow the pinwheel with parental assistance for stabilization and comfort.

3. Control Group:

* Children will receive standard care with parental presence but no additional interventions during venipuncture.

* After the procedure, children will be allowed to play a "pinprick" game and choose a small toy as a reward.

Outcome Measures

The effectiveness of the interventions will be measured using the following tools

1. The Wong-Baker Faces Pain Scale (WBFPS):

* Used to assess children's self-reported pain levels before and after venipuncture.

* Scores range from 0 to 10, with higher scores indicating greater pain.

2. Parental State Anxiety Scale:

* A Chinese version of the state anxiety scale will be used to measure parents' anxiety levels.

* Scores range from 1 to 4 for each item, with higher scores indicating greater anxiety.

3. Parental Satisfaction Scale:

* A 0-10 scale will be used to measure parents' satisfaction with the venipuncture process.

4. The Children's Fear Scale:

* Used to assess children's fear levels before and after venipuncture.

* Scores range from 0 to 4, with higher scores indicating greater fear.

5. FLACC (Face, Legs, Activity, Cry, Consolability) Pain Assessment Scale:

* Used to assess pain in non-verbal children based on facial expressions, leg movements, activity, cry, and consolability.

* Scores range from 0 to 10, with higher scores indicating greater pain.

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.

Study Timeline

• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-05
• Study Start: 2024-07-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-05-16
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• aged 3-6 years.
• undergoing intravenous infusion or blood draw during the hospital stay.

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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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blowing Pinwheels	Blowing Pinwheels	Participants will blow pinwheels during the venipuncture procedure, using breathing control and distraction to reduce pain and fear.
Video-watching group	Video-watching	Participants will watch age-appropriate and engaging videos during the venipuncture procedure to distract them from pain and fear.

Primary Outcome Measures

Name	Time	Method
Children's Fear Scale (CFS)	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	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	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 Outcome Measures

Name	Time	Method
Parental State Anxiety Scale (PSAS)	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.
Satisfaction of parents	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.

Trial Locations

Locations (1)

Taichung Veterans' General Hospital; 🇨🇳 Taichung, Taiwan