NCT07350980

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

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 28, 2025

Last Update Submit

January 10, 2026

Conditions

Keywords

newborn

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)

EXPERIMENTAL

Lavender

Other: oil

intervention group (tangerine)

EXPERIMENTAL

tangerine

Other: oil

Control group

NO INTERVENTION

rutin

Interventions

oilOTHER

experiment

intervention group (Lavender)intervention group (tangerine)

Eligibility Criteria

Age37 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Oils

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 2 intervention, 1 control
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

Locations