NCT07443735

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

February 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 23, 2026

Last Update Submit

February 23, 2026

Conditions

Outcome Measures

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.

    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

    The scale will be administered and recorded by the observer nurse immediately before the procedure, during venous blood sampling, and immediately after the procedure.

Study Arms (3)

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.

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.

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.

Interventions

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.

Bubble Blowing 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.

Pinwheel Group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr. Öğr. Üyesi Esra Nur KOCASLAN MUTLU

    Bağsız

    STUDY DIRECTOR

Central Study Contacts

Cansu Edi, Principal Investigator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Öğr. Üyesi

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 2, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical considerations and institutional data protection policies.