The Effect of Scents Applied During Heel Blood Collection on Newborn Crying Duration, Pain, and Physiological Parameters
Randomized
1 other identifier
interventional
120
1 country
1
Brief Summary
One of the most common and painful procedures in newborns is taking a capillary blood sample from the heel. This basic procedure, widely used in early health assessments, particularly in newborn screening tests, can cause mild to moderate pain.While both pharmacological and non-pharmacological approaches are used in pain management in newborns, the primary goal is to minimize and prevent painful stimuli as much as possible. Non-pharmacological methods are preferred in newborn care because they have no side effects, are easy to apply, low-cost, and caregiver-friendly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
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 Start
First participant enrolled
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2025
CompletedFirst Submitted
Initial submission to the registry
December 28, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2026
CompletedJanuary 20, 2026
December 1, 2025
3 months
December 28, 2025
January 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
crying times
measuring the crying duration with a stopwatch
Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.
heart rate
Measurement with pulse oximeter
Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.
Neonatal infant pain scale
The scale includes f ive behavioral parameters (facial expression, crying, armmovements, leg movements, and state of arousal) and one physiological parameter (breathing patterns). Each behavior is scored 0-1; the crying parameter is scored 0-1-2. The lowest score is 0 and the highest score is 7.
Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.
Study Arms (3)
intervention group (Lavender)
EXPERIMENTALLavender
intervention group (tangerine)
EXPERIMENTALtangerine
Control group
NO INTERVENTIONrutin
Interventions
Eligibility Criteria
You may qualify if:
- Gestational age between 38-42 weeks,
- APGAR score of 7 or higher at 5 minutes,
- Neither mother nor baby should have used sedatives, tranquilizers, or anticonvulsants in the last 24 hours,
- Heel prick blood should be planned as part of the routine neonatal screening program,
- No blood should be taken from the heel prick for any other reason before the procedure,
- Parents should voluntarily participate in the study.
You may not qualify if:
- Gestational age of 37 weeks or less,
- APGAR score of 6 or lower at 5 minutes,
- Having a diagnosed lung disease,
- Having a history of atopic dermatitis, hypersensitivity, or allergies,
- Parents should not wish to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sakarya University
Sakarya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 28, 2025
First Posted
January 20, 2026
Study Start
June 25, 2025
Primary Completion
September 15, 2025
Study Completion
October 20, 2025
Last Updated
January 20, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons