Pain, AcuteNCT05904483
The Effects of Finger Puppet, Abeslang Puzzle, and Pinwheel on Pain and Anxiety During Blood Sampling Procedures
A study testing PFA in people with Pain, Acute and Anxiety, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
Blood sampling is an invasive, diagnostic, and therapeutic procedure for children. The inability of preschool children to differentiate between reality and imagination and their belief in the power of their thoughts make it difficult for them to accept an invasive procedure. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Pain, Acute, Anxiety, Child, Only
- What is being tested?
- PFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2023to 21 Jun 2024
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between 4-6 years old
- Referring to the pediatric emergency department
- Having consent and approval from the parent and child to participate in the study
- Having a necessity for blood testing in the child.
Who cannot join
- Having visual, hearing, or speech impairment
- Having chronic or genetic diseases
- Having intellectual disability
- Having a history of sedative, narcotic, or analgesic drug use within the past 24 hours
- Having inflammatory diseases
- Being classified under the red triage category
- Unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Finger Puppet, Abeslang Puzzle, and Pinwheel on Pain and Anxiety in Children Aged 4-6 Years During Blood Sampling Procedures in Emergency Rooms: A Randomized Controlled Study
Blood sampling is an invasive, diagnostic, and therapeutic procedure for children. The inability of preschool children to differentiate between reality and imagination and their belief in the power of their thoughts make it difficult for them to accept an invasive procedure. Distraction techniques are used to help children cope with pain and anxiety. The aim of this study is to compare the effects of finger puppet, abeslang puzzle, and pinwheel on pain and anxiety during blood sampling in preschool children presenting to the pediatric emergency department. This randomized controlled study used parallel trial design.
Read the detailed description
The research hypotheses are as follows: H1: Children in the finger puppet group experience lower procedure-related pain than those in the control group. H2: Children in the pinwheel group experience lower procedure-related pain than those in the control group. H3: Children in the abeslang puzzle group experience lower procedure-related pain than those in the control group. H4: Children in the finger puppet group have lower anxiety than those in the control group. H5: Children in the pinwheel group have lower anxiety than those in the control group. H6: Children in the abeslang group have lower anxiety than those in the control group.
Methods:
This randomized controlled study plans to include children aged 4-6 years presenting to the pediatric emergency department of Bartın Maternity and Child Health Hospital. The study utilizes a parallel trial design, defining three different intervention groups (pinwheel, abeslang puzzle, finger puppet) and a control group (standard care). An independent statistician (www.randomize.org) allocates participants to groups using a randomization method according to sampling criteria. Since there is no similar study about the effects of finger puppet, abeslang puzzle, and pinwheel on pain and anxiety during blood sampling in children, the study aims for a medium effect size (0.25) to determine the sample size (Cohen, 2013). Considering a medium effect size (f: 0.25), a power of 80% (1 - β error), and a confidence level of 95% (α error), the sample of the study should include 180 children (G*Power 3.1.9.7) (Faul, 2014). Considering potential data losses, the sample size is increased by 10%, resulting in 200 children with 50 children in each group. Children and their parents are informed about the study, and after obtaining their consent, they are assigned to their respective groups.
A standard approach is applied to all pediatric patients, which includes providing information about the procedure, introducing the nurse, selecting the intervention area together, having the parent present during the procedure, and engaging in conversation with the child. No additional intervention is applied to children in the control group, and after obtaining their parental consent, they are observed during the procedure.
In the finger puppet group, a finger puppet made of felt is introduced to the selected child, and a story (Brave Little Rabbit) is told using the finger puppet. The finger puppet is wiped with a disinfectant before and after the intervention.
In the abeslang puzzle group, a puzzle made of colorful abeslang pieces with animal images (sheep, duck) is introduced to the selected child, and then the child is asked to complete the puzzle using their non-dominant hand, while the blood sampling procedure is being performed. Each child in the abeslang puzzle group receives the same number of puzzle pieces with the same design.
In the pinwheel group, a windmill made of colored cardboard is introduced to the selected child, and then the child is asked to blow on the pinwheel during the blood sampling procedure. The pinwheel is wiped with a disinfectant before and after the intervention.
All blood sampling procedures are performed by the same nurse, and the same researcher is present during all interventions.
Research data is collected by the following data collection forms:
Personal Information Form: The form consists of 4 questions in total, including age, gender, presence of previous injection experience, and number of previous injection experience.
Wong-Baker FACES (WB-FACES) Pain Rating Scale: This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10.
The Children's Anxiety Meter (CAM). This scale assesses children's anxiety in clinical settings and uses before medical procedures. Children are asked to mark how they feel "right now" to measure state anxiety (CAM-S). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.
- Conditions
- Pain, Acute, Anxiety, Child, Only
- Being tested
- PFA
- Medical subject headings
- Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFAOther
PFA
| Study group | Role | What they receive |
|---|---|---|
| Pinwheel Group | Experimental | In the pinwheel group, a windmill made of colored cardboard is introduced to the children, and then they are asked to blow on the pinwheel during the blood sampling procedure.The blood sampling is terminated at the same time by blowing the pinwheel. Receives: Other: PFA |
| Finger Puppet Group | Experimental | In the finger puppet group, a finger puppet made of felt is introduced to the children, and they are told a story (Brave Little Rabbit) by the same researcher using the finger puppet.The blood sampling is terminated at the same time by reading story with finger puppet. Receives: Other: PFA |
| Abeslang Puzzle Group | Experimental | In the abeslang puzzle group, a puzzle made of colorful abeslang pieces with animal images (sheep, duck) is introduced to the children, and then they are asked to complete the puzzle using their non-dominant hand during the blood sampling procedure.The blood sampling is terminated at the same time by completing abeslang puzzle. Receives: Other: PFA |
| Control | No intervention | Children in the control group are monitored during the blood sampling procedure if their informed consent is obtained by the researcher. They have the routine blood draw procedure, and do not receive any distraction techniques and other pharmacological interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of pain during blood sampling is evaluated using the Wong-Baker FACES Pain Rating Scale
This scale is used to assess the severity of pain in children aged 3 years and above. This numerical rating scale ranges from 0 to 10, indicating emotions ranging from no pain/very happy (0) to crying/hurts worst (10). Higher scores indicate a lower pain tolerance. In this study, this scale is evaluated using personal reports and records from children, their parents, the researcher, and the nurse after the blood sampling procedure.
Measured: during the procedure
Secondary outcomes (1)
The level of anxiety is evaluated using the Children Anxiety Meter-State
The Children's Anxiety Meter (CAM-S) assesses children's anxiety in clinical settings and is used prior to medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom and contains horizontal lines at intervals going upwards. Scale scores range from 0 to 10, where higher values represent higher anxiety. Personal reports and records from children, their parents, the researcher, and the nurse, who are asked to mark the scale with a pen, are used to assess the anxiety levels of children regarding blood sampling before and after the procedure.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start20 Jun 2023
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
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 Pain, AcuteStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Dinç, Bartın Unıversity
- Investigators
- Fatma Dinç, PhD Student, Principal investigator, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904483
- Sponsor's protocol ID
- 2023-BRT-SBF-112234
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Dinc F, Kurt A, Gunes San E. The effect of three different methods on pain and anxiety in children during blood sampling procedure in pediatric emergency department: Finger puppet, abeslang puzzle, pinwheel. J Pediatr Nurs. 2024 Nov-Dec;79:e203-e212. doi: 10.1016/j.pedn.2024.10.023. Epub 2024 Oct 24.
PubMed 39448323
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Finger Puppet, Abeslang Puzzle, and Pinwheel on Pain and Anxiety in Children Aged 4-6 Years During Blood Sampling Procedures in Emergency Rooms: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05904483
- Acronym / sponsor ID
- 2023-BRT-SBF-112234
- Conditions
- Pain, Acute, Anxiety, Child, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 15 Jun 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.
Blood sampling is an invasive, diagnostic, and therapeutic procedure for children. The inability of preschool children to differentiate between reality and imagination and their belief in the power of their thoughts make it difficult for them to accept an invasive procedure. Distraction techniques are used to help children cope with pain and anxiety. The aim of this study is to compare the effects of finger puppet, abeslang puzzle, and pinwheel on pain and anxiety during blood sampling in preschool children presenting to the pediatric emergency department. This randomized controlled study used parallel trial design.
Detailed description
The research hypotheses are as follows: H1: Children in the finger puppet group experience lower procedure-related pain than those in the control group. H2: Children in the pinwheel group experience lower procedure-related pain than those in the control group. H3: Children in the abeslang puzzle group experience lower procedure-related pain than those in the control group. H4: Children in the finger puppet group have lower anxiety than those in the control group. H5: Children in the pinwheel group have lower anxiety than those in the control group. H6: Children in the abeslang group have lower anxiety than those in the control group.
Methods:
This randomized controlled study plans to include children aged 4-6 years presenting to the pediatric emergency department of Bartın Maternity and Child Health Hospital. The study utilizes a parallel trial design, defining three different intervention groups (pinwheel, abeslang puzzle, finger puppet) and a control group (standard care). An independent statistician (www.randomize.org) allocates participants to groups using a randomization method according to sampling criteria. Since there is no similar study about the effects of finger puppet, abeslang puzzle, and pinwheel on pain and anxiety during blood sampling in children, the study aims for a medium effect size (0.25) to determine the sample size (Cohen, 2013). Considering a medium effect size (f: 0.25), a power of 80% (1 - β error), and a confidence level of 95% (α error), the sample of the study should include 180 children (G*Power 3.1.9.7) (Faul, 2014). Considering potential data losses, the sample size is increased by 10%, resulting in 200 children with 50 children in each group. Children and their parents are informed about the study, and after obtaining their consent, they are assigned to their respective groups.
A standard approach is applied to all pediatric patients, which includes providing information about the procedure, introducing the nurse, selecting the intervention area together, having the parent present during the procedure, and engaging in conversation with the child. No additional intervention is applied to children in the control group, and after obtaining their parental consent, they are observed during the procedure.
In the finger puppet group, a finger puppet made of felt is introduced to the selected child, and a story (Brave Little Rabbit) is told using the finger puppet. The finger puppet is wiped with a disinfectant before and after the intervention.
In the abeslang puzzle group, a puzzle made of colorful abeslang pieces with animal images (sheep, duck) is introduced to the selected child, and then the child is asked to complete the puzzle using their non-dominant hand, while the blood sampling procedure is being performed. Each child in the abeslang puzzle group receives the same number of puzzle pieces with the same design.
In the pinwheel group, a windmill made of colored cardboard is introduced to the selected child, and then the child is asked to blow on the pinwheel during the blood sampling procedure. The pinwheel is wiped with a disinfectant before and after the intervention.
All blood sampling procedures are performed by the same nurse, and the same researcher is present during all interventions.
Research data is collected by the following data collection forms:
Personal Information Form: The form consists of 4 questions in total, including age, gender, presence of previous injection experience, and number of previous injection experience.
Wong-Baker FACES (WB-FACES) Pain Rating Scale: This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10.
The Children's Anxiety Meter (CAM). This scale assesses children's anxiety in clinical settings and uses before medical procedures. Children are asked to mark how they feel "right now" to measure state anxiety (CAM-S). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pinwheel Group | Experimental | Other: PFAIn the pinwheel group, a windmill made of colored cardboard is introduced to the children, and then they are asked to blow on the pinwheel during the blood sampling procedure.The blood sampling is terminated at the same time by blowing the pinwheel. |
| Finger Puppet Group | Experimental | Other: PFAIn the finger puppet group, a finger puppet made of felt is introduced to the children, and they are told a story (Brave Little Rabbit) by the same researcher using the finger puppet.The blood sampling is terminated at the same time by reading story with finger puppet. |
| Abeslang Puzzle Group | Experimental | Other: PFAIn the abeslang puzzle group, a puzzle made of colorful abeslang pieces with animal images (sheep, duck) is introduced to the children, and then they are asked to complete the puzzle using their non-dominant hand during the blood sampling procedure.The blood sampling is terminated at the same time by completing abeslang puzzle. |
| Control | No intervention | –Children in the control group are monitored during the blood sampling procedure if their informed consent is obtained by the researcher. They have the routine blood draw procedure, and do not receive any distraction techniques and other pharmacological interventions. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being between 4-6 years old
- Referring to the pediatric emergency department
- Having consent and approval from the parent and child to participate in the study
- Having a necessity for blood testing in the child.
Key exclusion criteria (7 listed)
- Having visual, hearing, or speech impairment
- Having chronic or genetic diseases
- Having intellectual disability
- Having a history of sedative, narcotic, or analgesic drug use within the past 24 hours
- Having inflammatory diseases
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 |
|---|---|---|
| PFAPFA | Other | Abeslang Puzzle Group, Finger Puppet Group, Pinwheel Group |
Primary outcome
The level of pain during blood sampling is evaluated using the Wong-Baker FACES Pain Rating Scale
Time frame: during the procedure
This scale is used to assess the severity of pain in children aged 3 years and above. This numerical rating scale ranges from 0 to 10, indicating emotions ranging from no pain/very happy (0) to crying/hurts worst (10). Higher scores indicate a lower pain tolerance. In this study, this scale is evaluated using personal reports and records from children, their parents, the researcher, and the nurse after the blood sampling procedure.
1 secondary outcome
The level of anxiety is evaluated using the Children Anxiety Meter-State
Time frame: during the procedure
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 Jun 2024.
- Derived from this study: PubMed 39448323Dinc F, Kurt A, Gunes San E. The effect of three different methods on pain and anxiety in children during blood sampling procedure in pediatric emergency department: Finger puppet, abeslang puzzle, pinwheel. J Pediatr Nurs. 2024 Nov-Dec;79:e203-e212. doi: 10.1016/j.pedn.2024.10.023. Epub 2024 Oct 24.
- Individual participant dataSharing planned: Yes
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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.
Fatma Dinç, PhD Student principal investigator
Bartın Unıversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFA in people with Pain, Acute and Anxiety, run by Bartın Unıversity 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 4 inclusion and 7 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 Jun 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 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?
The level of pain during blood sampling is evaluated using the Wong-Baker FACES Pain Rating Scale (time frame: during the procedure). 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 NCT05904483, 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 Jun 2024.