NeonatalRandomizedNCT07350980
The Effect of Scents Applied During Heel Blood Collection on Newborn Crying Duration, Pain, and Physiological Parameters
A study testing oil in people with Neonatal and Pain Management, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal, Pain Management
- What is being tested?
- oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal, Pain Management
- Being tested
- oil
- Keywords
- newborn
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oilOther
experiment
| Study group | Role | What they receive |
|---|---|---|
| intervention group (Lavender) | Experimental | Lavender Receives: Other: oil |
| intervention group (tangerine) | Experimental | tangerine Receives: Other: oil |
| Control group | No intervention | rutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
crying times
measuring the crying duration with a stopwatch
Measured: Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.
heart rate
Measurement with pulse oximeter
Measured: 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.
Measured: Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start25 Jun 2025
- Primary completion15 Sep 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonatalStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 intervention, 1 control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350980
- Sponsor's protocol ID
- Oznur T.
- Acronym
- Randomized
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Scents Applied During Heel Blood Collection on Newborn Crying Duration, Pain, and Physiological Parameters; A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07350980
- Acronym / sponsor ID
- Randomized / Oznur T.
- Conditions
- Neonatal, Pain Management
- Keywords
- newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 2 intervention, 1 control
| Arm | Type | Receives |
|---|---|---|
| intervention group (Lavender) | Experimental | Other: oilLavender |
| intervention group (tangerine) | Experimental | Other: oiltangerine |
| Control group | No intervention | –rutin |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oilexperiment | Other | intervention group (Lavender), intervention group (tangerine) |
Primary outcome
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
heart rate
Time frame: Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.
Measurement with pulse oximeter
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oil in people with Neonatal and Pain Management, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
crying times (time frame: Before the procedure, during the procedure, and for a total of 10 minutes after the procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.