PainNCT05827783
The Effect of Buzzy and Puppet on Pain and Fear
A study testing Implementation of Bee Buzzy and Implementation of Puppet Zuzu in people with Pain and Fear, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Summary Aim: This study was conducted to evaluate the effects of the use of Bee Buzzy, external vibrating cold application, and the use of puppets on pain and fear in children aged 3 to 6 years during phlebotomy. Method: This study is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Fear, Nurse's Role
- What is being tested?
- Implementation of Bee Buzzy and Implementation of Puppet Zuzu
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants whose child and parents agreed to participate in the study
- Children who had successful phlebotomy on the first attempt
Who cannot join
- Children with chronic disease, mental disability, or mental retardation
- Children who had taken analgesics in the last 24 hours
- Children who were hospitalized
- Children who had undergone a surgical procedure
- Children who did not have successful phlebotomy on the first attempt
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Buzzy and Puppet on Pain and Fear During Phlebotomy in Children: A Randomized Controlled Study
Summary Aim: This study was conducted to evaluate the effects of the use of Bee Buzzy, external vibrating cold application, and the use of puppets on pain and fear in children aged 3 to 6 years during phlebotomy.
Method: This study is a randomized controlled trial. The study was conducted with 105 children aged 3-6 years who came to the pediatric phlebotomy unit of a university hospital. The sample of children (n=105) was divided into groups (group 1, Bee Buzzy; group 2, puppet; group 3, control) by block randomization. Children's pain and fear scores were evaluated using the Wong-Baker Pain Scale and Child Fear Scale, as well as the investigator's report, after phlebotomy, their parents, and the nurse who attempted phlebotomy.
- Conditions
- Pain, Fear, Nurse's Role
- Being tested
- Implementation of Bee Buzzy, Implementation of Puppet Zuzu
- Keywords
- Pain, Fear, External cold and vibration, pediatrics, Puppet
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of Bee BuzzyProcedure or surgery
Implementation of Bee Buzzy It is defined as the use of a device called Bee Buzzy, which applies cold and vibrates in the form of a toy bee, by the researcher for fear and pain during phlebotomy in children.
Nurse performs phlebotomy on pediatric patients in the pediatric phlebotomy unit. During this application, the researcher puts the Bee Buzzy device on the child's arm just above the area from which blood was taken, and remains attached to the arm during the phlebotomy procedure. This device applies cold and vibrates. Pain and fear during the procedure are evaluated by the researcher, the nurse, and the child's parent.
Implementation of Puppet ZuzuProcedure or surgery
Implementation of puppet zuzu It is defined as the use of a puppet that is seized and made to talk by the researcher for fear and pain during phlebotomy in children.
Nurse performs phlebotomy on pediatric patients in the pediatric phlebotomy unit. During this practice, a puppet is seized by the researcher and made to talk, and the child's attention is tried to be drawn. While this procedure is in progress, the researcher, the nurse, and the child's parent evaluate the pain and fear during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Bee Buzzy | Experimental | Bee Buzzy Group: Bee Buzzy was attached to the 3-6-year-old child included in this group by the researcher on the arm of the nurse to perform the phlebotomy procedure. Bee Buzzy reduces pain thanks to its cold wings and vibration. It helps to distract attention during phlebotomy and reduces the feeling of pain and fear. Bee Buzzy was tied 5 cm above the area from which blood will be drawn, and after waiting for 15 seconds, the nurse performed a phlebotomy. Receives: Procedure: Implementation of Bee Buzzy |
| Puppet Zuzu | Experimental | While the nurse was going to perform the phlebotomy operation on the 3-6-year-old child included in this group, one of the researchers (no. 2) tried to distract the child by putting the puppet on her hand and making her talk. The puppet used is an easy-to-use and hand-held puppet that will not cause fear in children. The puppet was named 'Zuzu' by researchers. Receives: Procedure: Implementation of Puppet Zuzu |
| Control | No intervention | No attempt was made to the 3-6-year-old child included in this group, during the process when the nurse performed the phlebotomy. Routine phlebotomy was performed. Pain and fear of the child during the procedure were evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical difference between groups about pain scores
Implementation of interventions aimed at reducing pain in experimental groups. Wong-Baker Facial Pain Rating Scale: The Facial Expression Rating Scale is a scale that includes 6 facial expressions and provides a rating between 0-10. This scale, which does not require words, is a reliable and valid measurement tool in the assessment of acute pain. A score of 0 indicates no pain and a score of 10 indicates the highest level of pain. In the scale, it means that as the pain score increases, the pain also increases.
Measured: During the procedure, approximately 5-10 minutes
Statistical difference between groups about fear scores
Implementation of interventions aimed at reducing fear in experimental groups. Children's Fear Scale: This scale includes 5 different facial expressions. This scale is scored between 0-4 and it is stated to be a reliable and valid measurement tool in the evaluation of fear. This scale does not require words. A score of 0 indicates no fear and a score of 4 indicates the highest level of fear. In the scale, it means that as the fear score increases, the fear also increases.
Measured: During the procedure, approximately 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start8 Jul 2022
- Primary completion17 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was a randomized controlled experimental study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyda BİNAY YAZ, Ege University
- Investigators
- Şeyda Binay Yaz, PhD, Principal investigator, Izmir Bakircay University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827783
- Sponsor's protocol ID
- Bakircay University
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yaz SB, Basdemir S, Gectan E. The effect of vibrating cold application and puppet use on pain and fear during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Jan-Feb;74:77-84. doi: 10.1016/j.pedn.2023.11.018. Epub 2023 Nov 28.
PubMed 38029689
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Buzzy and Puppet on Pain and Fear During Phlebotomy in Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05827783
- Acronym / sponsor ID
- Bakircay University
- Conditions
- Pain, Fear, Nurse's Role
- Keywords
- Pain, Fear, External cold and vibration, pediatrics, Puppet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 25 Apr 2023 (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.
Summary Aim: This study was conducted to evaluate the effects of the use of Bee Buzzy, external vibrating cold application, and the use of puppets on pain and fear in children aged 3 to 6 years during phlebotomy.
Method: This study is a randomized controlled trial. The study was conducted with 105 children aged 3-6 years who came to the pediatric phlebotomy unit of a university hospital. The sample of children (n=105) was divided into groups (group 1, Bee Buzzy; group 2, puppet; group 3, control) by block randomization. Children's pain and fear scores were evaluated using the Wong-Baker Pain Scale and Child Fear Scale, as well as the investigator's report, after phlebotomy, their parents, and the nurse who attempted phlebotomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The study was a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Bee Buzzy | Experimental | Procedure: Implementation of Bee BuzzyBee Buzzy Group: Bee Buzzy was attached to the 3-6-year-old child included in this group by the researcher on the arm of the nurse to perform the phlebotomy procedure. Bee Buzzy reduces pain thanks to its cold wings and vibration. It helps to distract attention during phlebotomy and reduces the feeling of pain and fear. Bee Buzzy was tied 5 cm above the area from which blood will be drawn, and after waiting for 15 seconds, the nurse performed a phlebotomy. |
| Puppet Zuzu | Experimental | Procedure: Implementation of Puppet ZuzuWhile the nurse was going to perform the phlebotomy operation on the 3-6-year-old child included in this group, one of the researchers (no. 2) tried to distract the child by putting the puppet on her hand and making her talk. The puppet used is an easy-to-use and hand-held puppet that will not cause fear in children. The puppet was named 'Zuzu' by researchers. |
| Control | No intervention | –No attempt was made to the 3-6-year-old child included in this group, during the process when the nurse performed the phlebotomy. Routine phlebotomy was performed. Pain and fear of the child during the procedure were evaluated. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants whose child and parents agreed to participate in the study
- Children who had successful phlebotomy on the first attempt
Key exclusion criteria (5 listed)
- Children with chronic disease, mental disability, or mental retardation
- Children who had taken analgesics in the last 24 hours
- Children who were hospitalized
- Children who had undergone a surgical procedure
- Children who did not have successful phlebotomy on the first attempt
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 |
|---|---|---|
| Implementation of Bee BuzzyImplementation of Bee Buzzy It is defined as the use of a device called Bee Buzzy, which applies cold and vibrates in the form of a toy bee, by the researcher for fear and pain during phlebotomy in children. Nurse performs phlebotomy on pediatric patients in the pediatric phlebotomy unit. During this application, the researcher puts the Bee Buzzy device on the child's arm just above the area from which blood was taken, and remains attached to the arm during the phlebotomy procedure. This device applies cold and vibrates. Pain and fear during the procedure are evaluated by the researcher, the nurse, and the child's parent. | Procedure or surgery | Bee Buzzy |
| Implementation of Puppet ZuzuImplementation of puppet zuzu It is defined as the use of a puppet that is seized and made to talk by the researcher for fear and pain during phlebotomy in children. Nurse performs phlebotomy on pediatric patients in the pediatric phlebotomy unit. During this practice, a puppet is seized by the researcher and made to talk, and the child's attention is tried to be drawn. While this procedure is in progress, the researcher, the nurse, and the child's parent evaluate the pain and fear during the procedure. | Procedure or surgery | Puppet Zuzu |
Primary outcome
Statistical difference between groups about pain scores
Time frame: During the procedure, approximately 5-10 minutes
Implementation of interventions aimed at reducing pain in experimental groups. Wong-Baker Facial Pain Rating Scale: The Facial Expression Rating Scale is a scale that includes 6 facial expressions and provides a rating between 0-10. This scale, which does not require words, is a reliable and valid measurement tool in the assessment of acute pain. A score of 0 indicates no pain and a score of 10 indicates the highest level of pain. In the scale, it means that as the pain score increases, the pain also increases.
Statistical difference between groups about fear scores
Time frame: During the procedure, approximately 5-10 minutes
Implementation of interventions aimed at reducing fear in experimental groups. Children's Fear Scale: This scale includes 5 different facial expressions. This scale is scored between 0-4 and it is stated to be a reliable and valid measurement tool in the evaluation of fear. This scale does not require words. A score of 0 indicates no fear and a score of 4 indicates the highest level of fear. In the scale, it means that as the fear score increases, the fear also increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 38029689Yaz SB, Basdemir S, Gectan E. The effect of vibrating cold application and puppet use on pain and fear during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Jan-Feb;74:77-84. doi: 10.1016/j.pedn.2023.11.018. Epub 2023 Nov 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Şeyda Binay Yaz, PhD principal investigator
Izmir Bakircay University 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 Implementation of Bee Buzzy and Implementation of Puppet Zuzu in people with Pain and Fear, run by Ege University at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 25 Apr 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical difference between groups about pain scores (time frame: During the procedure, approximately 5-10 minutes). The study lists 2 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 NCT05827783, which also lists 1 linked publication.
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 25 Apr 2023.