Pain and Emotional Responses in Children During Venous Blood SamplingNCT07443735
Pinwheel and Bubble Blowing for Pain and Emotional Responses in Children
A study testing Bubble Blowing Group and Pinwheel Group in people with Pain and Emotional Responses in Children During Venous Blood Sampling, run by Trakya University.
Trial summary
Venous blood sampling is one of the most frequently performed invasive procedures in children during diagnostic and treatment processes and may lead to pain, fear, and negative emotional responses. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain and Emotional Responses in Children During Venous Blood Sampling
- What is being tested?
- Bubble Blowing Group and Pinwheel Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Apr 2027
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3-6 years
- Willingness to undergo intravenous blood collection
- Children's ability to apply distraction techniques during blood collection
- No communication problems in children
- No mental or neurological disability in the child
- Venous blood collection performed in a single session
- Parents and children must be willing to participate in the study
Who cannot join
- Children not being between the ages of 3 and 6
- Absence of intravenous blood collection request
- Communication problems in children
- Presence of mental or neurological disability in the child
- Complaints that disrupt the child's comfort, such as pain, nausea, vomiting, etc., due to other reasons
- Use of analgesic or sedative medication within 6 hours prior to the study
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- Absence of healthy skin integrity
- Repeated attempts
- Unexpected events occurring during blood collection
- Parents or children not volunteering to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of Pinwheel and Bubble Blowing on Pain and Emotional Responses in Children During Venous Blood Sampling
Venous blood sampling is one of the most frequently performed invasive procedures in children during diagnostic and treatment processes and may lead to pain, fear, and negative emotional responses. Such negative experiences in childhood may contribute to the development of anxiety toward healthcare services and reduced cooperation with healthcare professionals during treatment. Therefore, the use of non-pharmacological interventions aimed at reducing pain levels and emotional responses during procedures is of great importance in pediatric care.
The aim of this study is to determine the effects of pinwheel and bubble blowing techniques applied during venous blood sampling on pain levels and emotional states in children. This study will be conducted as a prospective, randomized controlled trial in the Blood Sampling Unit of the Pediatric Outpatient Clinic of a university hospital located in Edirne. A total of 66 children aged 3-6 years who will undergo venous blood sampling will be included in the study (pinwheel group: 22, bubble blowing group: 22, control group: 22).
Study data will be collected using the Child and Family Information Form, the Wong-Baker Faces Pain Rating Scale, and the Children's Emotional Indicators Scale. During venous blood sampling, pinwheel or bubble blowing techniques will be applied to the children in the experimental groups, while routine procedures will be performed for the children in the control group. The collected data will be analyzed using appropriate statistical methods. The results of this study are expected to contribute to the dissemination of evidence-based non-pharmacological practices aimed at reducing pain and emotional stress in pediatric nursing care.
- Being tested
- Bubble Blowing Group, Pinwheel Group
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble Blowing GroupOther
The bubble blowing technique will be applied to randomly selected children during blood collection. Prior to the procedure, parents (mothers) will complete a "Child and Family Information Form," and the children's pain and emotional responses will be recorded by the researcher through observation using the Wong-Baker Pain Scale and the Emotional Indicators Scale (EIS).
- During the intervention, children will be shown the bubble blowing technique and their attention will be diverted. Compliance with the intervention will be assessed based on the researcher's observations and parental feedback.
- After the procedure, the same scales will be completed by the researcher, and changes in the children's pain and emotional states will be monitored.
Pinwheel GroupOther
The pinwheel blowing technique will be applied to randomly selected children during blood collection. Before the procedure, parents (mothers) will fill out a "Child and Family Information Form," and the children's pain and emotional responses will be observed by the researcher using the Wong-Baker Facial Pain Scale and EIS.
- The use of the pinwheel will be demonstrated during the intervention, and the children's attention will be diverted. Compliance with the intervention will be monitored through the researcher's observations and parental feedback.
- After the procedure, the children's pain and emotional states will be recorded by the researcher using the same scales.
| Study group | Role | What they receive |
|---|---|---|
| Pinwheel Group | Experimental | Children aged 3-6 years undergoing venous blood sampling who receive pinwheel blowing in addition to standard care. Children's pain levels and emotional responses are evaluated. Receives: Other: Pinwheel Group |
| Bubble Blowing Group | Experimental | Children aged 3-6 years undergoing venous blood sampling who receive bubble blowing in addition to standard care. Children's pain levels and emotional responses are evaluated. Receives: Other: Bubble Blowing Group |
| Standard Care Group | No intervention | Children aged 3-6 years undergoing venous blood sampling who receive standard care only. Children's pain levels and emotional responses are evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Pain Level
Children's pain levels will be assessed using the Wong-Baker Faces Pain Scale. This scale consists of six facial expressions ranging from 0 (no pain) to 10 (worst pain). Children indicate their perceived pain intensity by selecting the face that best represents their pain.
Measured: The scale will be administered and recorded by the researcher nurse during the procedure and 1 minute after the procedure is completed.
Secondary outcomes (1)
Children's Emotional Status
Children's emotional responses will be assessed using the Children's Emotional Indicators Scale. The scale includes five parameters: facial expression, vocalization, activity, interaction, and cooperation. Each parameter is scored between 1 and 5, with total scores ranging from 5 to 25. Higher scores indicate more negative emotional responses. The scale will be applied by an observer nurse to evaluate children's emotional reactions such as fear, anxiety, and distress.
Measured: The scale will be administered and recorded by the observer nurse immediately before the procedure, during venous blood sampling, and immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain and Emotional Responses in Children During Venous Blood SamplingStudies 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
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Nur Kocaaslan Mutlu, Trakya University
- Investigators
- Dr. Öğr. Üyesi Esra Nur KOCASLAN MUTLU, Study director, Bağsız
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443735
- Sponsor's protocol ID
- TUTF-SBF-CE-26
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pinwheel and Bubble Blowing on Pain and Emotional Responses in Children During Venous Blood Sampling
- ClinicalTrials.gov ID
- NCT07443735
- Acronym / sponsor ID
- TUTF-SBF-CE-26
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 2 Mar 2026 (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.
Venous blood sampling is one of the most frequently performed invasive procedures in children during diagnostic and treatment processes and may lead to pain, fear, and negative emotional responses. Such negative experiences in childhood may contribute to the development of anxiety toward healthcare services and reduced cooperation with healthcare professionals during treatment. Therefore, the use of non-pharmacological interventions aimed at reducing pain levels and emotional responses during procedures is of great importance in pediatric care.
The aim of this study is to determine the effects of pinwheel and bubble blowing techniques applied during venous blood sampling on pain levels and emotional states in children. This study will be conducted as a prospective, randomized controlled trial in the Blood Sampling Unit of the Pediatric Outpatient Clinic of a university hospital located in Edirne. A total of 66 children aged 3-6 years who will undergo venous blood sampling will be included in the study (pinwheel group: 22, bubble blowing group: 22, control group: 22).
Study data will be collected using the Child and Family Information Form, the Wong-Baker Faces Pain Rating Scale, and the Children's Emotional Indicators Scale. During venous blood sampling, pinwheel or bubble blowing techniques will be applied to the children in the experimental groups, while routine procedures will be performed for the children in the control group. The collected data will be analyzed using appropriate statistical methods. The results of this study are expected to contribute to the dissemination of evidence-based non-pharmacological practices aimed at reducing pain and emotional stress in pediatric nursing care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pinwheel Group | Experimental | Other: Pinwheel GroupChildren aged 3-6 years undergoing venous blood sampling who receive pinwheel blowing in addition to standard care. Children's pain levels and emotional responses are evaluated. |
| Bubble Blowing Group | Experimental | Other: Bubble Blowing GroupChildren aged 3-6 years undergoing venous blood sampling who receive bubble blowing in addition to standard care. Children's pain levels and emotional responses are evaluated. |
| Standard Care Group | No intervention | –Children aged 3-6 years undergoing venous blood sampling who receive standard care only. Children's pain levels and emotional responses are evaluated. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 3-6 years
- Willingness to undergo intravenous blood collection
- Children's ability to apply distraction techniques during blood collection
- No communication problems in children
- No mental or neurological disability in the child
Key exclusion criteria (10 listed)
- Children not being between the ages of 3 and 6
- Absence of intravenous blood collection request
- Communication problems in children
- Presence of mental or neurological disability in the child
- Complaints that disrupt the child's comfort, such as pain, nausea, vomiting, etc., due to other reasons
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 |
|---|---|---|
| Bubble Blowing GroupThe bubble blowing technique will be applied to randomly selected children during blood collection. Prior to the procedure, parents (mothers) will complete a "Child and Family Information Form," and the children's pain and emotional responses will be recorded by the researcher through observation using the Wong-Baker Pain Scale and the Emotional Indicators Scale (EIS). * During the intervention, children will be shown the bubble blowing technique and their attention will be diverted. Compliance with the intervention will be assessed based on the researcher's observations and parental feedback. * After the procedure, the same scales will be completed by the researcher, and changes in the children's pain and emotional states will be monitored. | Other | Bubble Blowing Group |
| Pinwheel GroupThe pinwheel blowing technique will be applied to randomly selected children during blood collection. Before the procedure, parents (mothers) will fill out a "Child and Family Information Form," and the children's pain and emotional responses will be observed by the researcher using the Wong-Baker Facial Pain Scale and EIS. * The use of the pinwheel will be demonstrated during the intervention, and the children's attention will be diverted. Compliance with the intervention will be monitored through the researcher's observations and parental feedback. * After the procedure, the children's pain and emotional states will be recorded by the researcher using the same scales. | Other | Pinwheel Group |
Primary outcome
Children's Pain Level
Time frame: The scale will be administered and recorded by the researcher nurse during the procedure and 1 minute after the procedure is completed.
Children's pain levels will be assessed using the Wong-Baker Faces Pain Scale. This scale consists of six facial expressions ranging from 0 (no pain) to 10 (worst pain). Children indicate their perceived pain intensity by selecting the face that best represents their pain.
1 secondary outcome
Children's Emotional Status
Time frame: The scale will be administered and recorded by the observer nurse immediately before the procedure, during venous blood sampling, and immediately after the 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 2 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations and institutional data protection policies.
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.
Dr. Öğr. Üyesi Esra Nur KOCASLAN MUTLU study director
Bağsız
Questions about this trial
What is this clinical trial studying?
A study testing Bubble Blowing Group and Pinwheel Group in people with Pain and Emotional Responses in Children During Venous Blood Sampling, run by Trakya University.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Cansu Edi, Principal Investigator (05452253790, cansuedi34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Pain Level (time frame: The scale will be administered and recorded by the researcher nurse during the procedure and 1 minute after the procedure is completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.