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

January 10, 2026 updated by: öznur tiryaki, Sakarya University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group (Lavender)
Lavender
Other: oil
experiment
Experimental: intervention group (tangerine)
tangerine
Other: oil
experiment
No Intervention: Control group
rutin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.
heart rate
Time Frame: Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.
Measurement with pulse oximeter
Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.
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.
Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2025

Primary Completion (Actual)

September 15, 2025

Study Completion (Actual)

October 20, 2025

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

January 10, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oznur T.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain Management

Clinical Trials on oil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe