PainNCT06489353
The Effect of Watching Video and Blowing Paper Pinwheels in Children
A study testing Video-watching and Blowing Pinwheels in people with Pain and Fear, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- What is being tested?
- Video-watching and Blowing Pinwheels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jul 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 3-6 years.
- undergoing intravenous infusion or blood draw during the hospital stay.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans' General Hospital
Taichung, 407219
HuiMing Hou, 886-4-23592525 ext. 8066, hmjj6x@yahoo.com.tw
About this study
Official title: The Effect of Watching Video and Blowing Paper Pinwheels on Pain and Fear in Children Undergoing Venipuncture.
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:
Read more
- 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.
Read the 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:
- 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.
- 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.
- 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
- 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.
- 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.
- Parental Satisfaction Scale:
- A 0-10 scale will be used to measure parents' satisfaction with the venipuncture process.
- 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.
- 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.
- Being tested
- Video-watching, Blowing Pinwheels
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-watchingBehavioural
Participants will watch age-appropriate and engaging videos.
Blowing PinwheelsBehavioural
Participants will blow pinwheels during the venipuncture procedure
| Study group | Role | What they receive |
|---|---|---|
| Video-watching group | Experimental | Participants will watch age-appropriate and engaging videos during the venipuncture procedure to distract them from pain and fear. Receives: Behavioral: Video-watching |
| Blowing Pinwheels | Experimental | Participants will blow pinwheels during the venipuncture procedure, using breathing control and distraction to reduce pain and fear. Receives: Behavioral: Blowing Pinwheels |
| routine care group | No intervention | Participants will receive standard routine care during the venipuncture procedure without additional interventions, serving as the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed immediately before and after the venipuncture procedure.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Assessed immediately after the child's venipuncture procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start18 Jul 2024
- Primary completion16 May 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will: * Be randomly assigned to one of three groups in parallel for the duration of the study: * Watch their preferred cartoons on an iPad during the venipuncture process. * Blow paper pinwheels to distract themselves during the venipuncture process. * Receive standard care without any additional distractions.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HuiMing Hou, Taichung Veterans General Hospital
- Investigators
- Hui-Ming Hou, MD, Principal investigator, Taichung Veterans' General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489353
- Sponsor's protocol ID
- CF24157B
- Status last verified
- Nov 2024
- First submitted
- 5 Jun 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen T, Wang X, Xue Q, Chen D. Active versus passive distraction for reducing procedural pain and anxiety in children: a meta-analysis and systematic review. Ital J Pediatr. 2023 Aug 31;49(1):109. doi: 10.1186/s13052-023-01518-4.
PubMed 37653423Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26.
PubMed 27112434Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4.
PubMed 22134226Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.
PubMed 23857075Vetri Buratti C, Angelino F, Sansoni J, Fabriani L, Mauro L, Latina R. Distraction as a technique to control pain in pediatric patients during venipuncture. A narrative review of literature. Prof Inferm. 2015 Jan-Mar;68(1):52-62. doi: 10.7429/pi.2015.681052.
PubMed 25837616da Silva JR, Pizzoli LM, Amorim AR, Pinheiros FT, Romanini GC, da Silva JG, Joanete S, Alves SS. Using Therapeutic Toys to Facilitate Venipuncture Procedure in Preschool Children. Pediatr Nurs. 2016 Mar-Apr;42(2):61-8.
PubMed 27254974Rimon A, Shalom S, Wolyniez I, Gruber A, Schachter-Davidov A, Glatstein M. Medical Clowns and Cortisol levels in Children Undergoing Venipuncture in the Emergency Department: A Pilot Study. Isr Med Assoc J. 2016 Nov;18(11):680-683.
PubMed 28466619Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.
PubMed 29155488Ballard A, Khadra C, Adler S, Doyon-Trottier E, Le May S. Efficacy of the Buzzy(R) device for pain management of children during needle-related procedures: a systematic review protocol. Syst Rev. 2018 May 22;7(1):78. doi: 10.1186/s13643-018-0738-1.
PubMed 29788987Susam V, Friedel M, Basile P, Ferri P, Bonetti L. Efficacy of the Buzzy System for pain relief during venipuncture in children: a randomized controlled trial. Acta Biomed. 2018 Jul 18;89(6-S):6-16. doi: 10.23750/abm.v89i6-S.7378.
PubMed 30038198Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.
PubMed 30284240Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.
PubMed 31047650Dumoulin S, Bouchard S, Ellis J, Lavoie KL, Vezina MP, Charbonneau P, Tardif J, Hajjar A. A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Games Health J. 2019 Aug;8(4):285-293. doi: 10.1089/g4h.2018.0111. Epub 2019 May 24.
PubMed 31135178Celikol S, Tural Buyuk E, Yildizlar O. Children's Pain, Fear, and Anxiety During Invasive Procedures. Nurs Sci Q. 2019 Jul;32(3):226-232. doi: 10.1177/0894318419845391.
PubMed 31203776Wong CL, Lui MMW, Choi KC. Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial. Trials. 2019 Jun 20;20(1):369. doi: 10.1186/s13063-019-3443-z.
PubMed 31221208
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Watching Video and Blowing Paper Pinwheels on Pain and Fear in Children Undergoing Venipuncture.
- ClinicalTrials.gov ID
- NCT06489353
- Acronym / sponsor ID
- CF24157B
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 16 May 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Interventions:
Participants will be randomly assigned to one of three groups:
- 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.
- 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.
- 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
- 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.
- 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.
- Parental Satisfaction Scale:
- A 0-10 scale will be used to measure parents' satisfaction with the venipuncture process.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will: * Be randomly assigned to one of three groups in parallel for the duration of the study: * Watch their preferred cartoons on an iPad during the venipuncture process. * Blow paper pinwheels to distract themselves during the venipuncture process. * Receive standard care without any additional distractions.
| Arm | Type | Receives |
|---|---|---|
| Video-watching group | Experimental | Behavioral: Video-watchingParticipants will watch age-appropriate and engaging videos during the venipuncture procedure to distract them from pain and fear. |
| Blowing Pinwheels | Experimental | Behavioral: Blowing PinwheelsParticipants will blow pinwheels during the venipuncture procedure, using breathing control and distraction to reduce pain and fear. |
| routine care group | No intervention | –Participants will receive standard routine care during the venipuncture procedure without additional interventions, serving as the control group. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 3-6 years.
- undergoing intravenous infusion or blood draw during the hospital stay.
Key exclusion criteria (6 listed)
- chronic diseases.
- developmental delays or epilepsy.
- difficulty speaking.
- hearing or visual impairments.
- use sedatives within the past 6 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-watchingParticipants will watch age-appropriate and engaging videos. | Behavioural | Video-watching group |
| Blowing PinwheelsParticipants will blow pinwheels during the venipuncture procedure | Behavioural | Blowing Pinwheels |
Primary outcome
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.
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.
2 secondary outcomes
Parental State Anxiety Scale (PSAS)
Time frame: Assessed immediately after the child's venipuncture procedure.
Satisfaction of parents
Time frame: Assessed immediately after the child's venipuncture procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 37653423Shen T, Wang X, Xue Q, Chen D. Active versus passive distraction for reducing procedural pain and anxiety in children: a meta-analysis and systematic review. Ital J Pediatr. 2023 Aug 31;49(1):109. doi: 10.1186/s13052-023-01518-4.
- Background: PubMed 27112434Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26.
- Background: PubMed 22134226Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4.
- Background: PubMed 23857075Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.
- Background: PubMed 25837616Vetri Buratti C, Angelino F, Sansoni J, Fabriani L, Mauro L, Latina R. Distraction as a technique to control pain in pediatric patients during venipuncture. A narrative review of literature. Prof Inferm. 2015 Jan-Mar;68(1):52-62. doi: 10.7429/pi.2015.681052.
- Background: PubMed 27254974da Silva JR, Pizzoli LM, Amorim AR, Pinheiros FT, Romanini GC, da Silva JG, Joanete S, Alves SS. Using Therapeutic Toys to Facilitate Venipuncture Procedure in Preschool Children. Pediatr Nurs. 2016 Mar-Apr;42(2):61-8.
- Background: PubMed 28466619Rimon A, Shalom S, Wolyniez I, Gruber A, Schachter-Davidov A, Glatstein M. Medical Clowns and Cortisol levels in Children Undergoing Venipuncture in the Emergency Department: A Pilot Study. Isr Med Assoc J. 2016 Nov;18(11):680-683.
- Background: PubMed 29155488Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.
- Background: PubMed 29788987Ballard A, Khadra C, Adler S, Doyon-Trottier E, Le May S. Efficacy of the Buzzy(R) device for pain management of children during needle-related procedures: a systematic review protocol. Syst Rev. 2018 May 22;7(1):78. doi: 10.1186/s13643-018-0738-1.
- Background: PubMed 30038198Susam V, Friedel M, Basile P, Ferri P, Bonetti L. Efficacy of the Buzzy System for pain relief during venipuncture in children: a randomized controlled trial. Acta Biomed. 2018 Jul 18;89(6-S):6-16. doi: 10.23750/abm.v89i6-S.7378.
- Background: PubMed 30284240Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.
- Background: PubMed 31047650Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.
- Individual participant dataSharing planned: No
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Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui-Ming Hou, MD principal investigator
Taichung Veterans' General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-watching and Blowing Pinwheels in people with Pain and Fear, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HuiMing Hou, MD (0933252727, hmjj6x@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker Faces Pain Scale (WBFPS) for Children's Self-Reported Pain (time frame: Assessed immediately before and after the venipuncture.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06489353, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.