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Not yet recruitingNCT07443735Updated Mar 2, 2026

Pinwheel and Bubble Blowing for Pain and Emotional Responses in Children

An interventional study of Bubble Blowing Group and Pinwheel Group in Pain and Emotional Responses in Children During Venous Blood Sampling, sponsored by Trakya University. Not yet recruiting. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by Trakya University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Pain and Emotional Responses in Children During Venous Blood Sampling

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03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 75 is above the median of 66 across 8,493 interventional studies indexed under Pain.

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Lead sponsor

Trakya University is the lead sponsor of 155 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Absence of healthy skin integrity
  • Repeated attempts
  • Unexpected events occurring during blood collection
  • Parents or children not volunteering to participate in the study
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Pinwheel Group

    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.

    Other: Pinwheel Group

  • Experimental
    Bubble Blowing Group

    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.

    Other: Bubble Blowing Group

  • No intervention
    Standard Care Group

    Children aged 3-6 years undergoing venous blood sampling who receive standard care only. Children's pain levels and emotional responses are evaluated.

Interventions

  • OtherBubble Blowing Group

    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.

  • OtherPinwheel Group

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    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.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to ethical considerations and institutional data protection policies.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07443735
Lead sponsor
Trakya University
Responsible party
Esra Nur Kocaaslan Mutlu (Dr. Öğr. Üyesi, Trakya University) — Principal investigator
First posted
Mar 2, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Mar 2, 2026

Study contacts

Cansu Edi, Principal Investigator
Contact
cansuedi34@gmail.com
05452253790
Dr. Öğr. Üyesi Esra Nur KOCASLAN MUTLU
study director · Bağsız

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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