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Completed

NCT Number: NCT07350980

The Effect of Scents Applied During Heel Blood Collection on Newborn Crying Duration, Pain, and Physiological Parameters

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.

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Key information

Conditions

Neonatal Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University

Sakarya, Turkey (Türkiye)

About this study

This study was designed as a prospective, three-arm, parallel-group randomized controlled trial. It focused on non-pharmacological methods (lavender oil, mandarin oil, control group/standard care).Mothers of newborns meeting the recruitment criteria were informed of the study before heel prick testing and provided verbal and written consent. The standard approach involves performing heel prick testing on all newborns in their mothers' arms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

oil

Other

experiment

Primary outcomes

  1. crying times

    Time frame: Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.

    measuring the crying duration with a stopwatch

  2. heart rate

    Time frame: Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.

    Measurement with pulse oximeter

  3. Neonatal infant pain scale

    Time frame: Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.

    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.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

The Effect of Scents Applied During Heel Blood Collection on Newborn Crying Duration, Pain, and Physiological Parameters; A Randomized Controlled Study.

Acronym: Randomized

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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