Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489353
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-05
Brief Title:
The Effect of Watching Video and Blowing Paper Pinwheels in Children
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
The Effect of Watching Video and Blowing Paper Pinwheels on Pain and Fear in Children Undergoing Venipuncture
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 childrens 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 Childrens Fear Scale
Used to assess childrens 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
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 childrens 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 Childrens Fear Scale
Used to assess childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None