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

NCT07350980 — Not applicable, Completed, 120 participants, Sakarya University

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

Registry	NCT07350980, acronym Randomized
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, health services research
Enrollment	120 (Actual)
Sponsor	Sakarya University (Other)
Conditions	Neonatal, Pain Management
Interventions	oil (Other)
Dates	start 2025-06-25, primary completion 2025-09-15, completion 2025-10-20, first posted 2026-01-20, last updated 2026-01-20
Locations	1 site in Turkey (Türkiye)

-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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
intervention group (Lavender)	Experimental	Other: oil	Lavender
intervention group (tangerine)	Experimental	Other: oil	tangerine
Control group	No intervention		rutin

oil (Other): experiment

+Outcome measures

Primary outcomes

crying times [Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.]: measuring the crying duration with a stopwatch
heart rate [Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.]: Measurement with pulse oximeter
Neonatal infant pain scale [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.

+Eligibility

Sex: All, ages: 37 Weeks to 42 Weeks, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Sakarya University	Sakarya	Turkey (Türkiye)