NewbornNCT05448508
The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection
A study testing Automatic lancet in people with Newborn and Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Heel blood sampling is a routine but painful procedure for newborns. A limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets. Read more about this study
- Who is it for?
- Ages 0 days to 1 dayHealthy volunteers can take part
- What is being tested?
- Automatic lancet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Jul 2022
- 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 0 days to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Postnatal age zero day
- Term newborn
- No congenital anomalies
- No advanced medical intervention at birth
- Infants not receiving oxygen or respiratory support
Who cannot join
- Legal guardian not giving consent to research
Trial locations and contacts
1 site in 1 country.
About this study
Heel blood sampling is a routine but painful procedure for newborns. A limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets.
In line with this information, this study was planned to investigate the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection.
- Being tested
- Automatic lancet
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic lancetDevice
An automatic lancet, which can reach a depth of 2.4 mm-3 mm, was used for safe piercing in babies.
| Study group | Role | What they receive |
|---|---|---|
| Automatic Lancet | Experimental | Manual lancet, needle tips and automatic lancets are used in the heel blood collection process. It has been reported that there may be complications arising from health professionals in the use of manual lancet or needle tip. In this study, an automatic lancet penetrating 2.4 mm-3 mm depth was used for safe puncture in term newborns. Receives: Device: Automatic lancet |
| Control | No intervention | No intervention, routine maintenance performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The neo pain assessment scale
The neo scale was developed (2014) to assess pain and stress in premature and mature neonates. The Neo is a five-item scale including facial expression, breathing pattern, tone of extremities, hand and foot activity, and level of activity. The lowest and the highest scores obtainable from the scale are 0 and 10, respectively. As the score increases, stress and pain increase.
Measured: 12 week
Crying time in second
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Apr 2022
- Primary completion30 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- MSc Meral Güven, MSc Reyhan YALÇIN, PhD Adem ASLAN
- Responsible party
- Principal investigator, Türkan Kadiroğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448508
- Sponsor's protocol ID
- TKP-2022-10664
- Status last verified
- Jul 2022
- First submitted
- 2 Jul 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kadiroglu T, Guven M, Yalcin R, Aslan A. The effects of manual and automatic lancet use on pain, stress, physiological parameters and crying duration during capillary heel blood collection in term neonates: a randomized controlled trial. BMC Nurs. 2025 Nov 18;24(1):1409. doi: 10.1186/s12912-025-04056-y.
PubMed 41254729
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection
- ClinicalTrials.gov ID
- NCT05448508
- Acronym / sponsor ID
- TKP-2022-10664
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- MSc Meral Güven, MSc Reyhan YALÇIN, PhD Adem ASLAN
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 7 Jul 2022 (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.
Heel blood sampling is a routine but painful procedure for newborns. A limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets.
In line with this information, this study was planned to investigate the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automatic Lancet | Experimental | Device: Automatic lancetManual lancet, needle tips and automatic lancets are used in the heel blood collection process. It has been reported that there may be complications arising from health professionals in the use of manual lancet or needle tip. In this study, an automatic lancet penetrating 2.4 mm-3 mm depth was used for safe puncture in term newborns. |
| Control | No intervention | –No intervention, routine maintenance performed |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Postnatal age zero day
- Term newborn
- No congenital anomalies
- No advanced medical intervention at birth
- Infants not receiving oxygen or respiratory support
Key exclusion criteria (1 listed)
- Legal guardian not giving consent to research
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 |
|---|---|---|
| Automatic lancetAn automatic lancet, which can reach a depth of 2.4 mm-3 mm, was used for safe piercing in babies. | Device | Automatic Lancet |
Primary outcome
The neo pain assessment scale
Time frame: 12 week
The neo scale was developed (2014) to assess pain and stress in premature and mature neonates. The Neo is a five-item scale including facial expression, breathing pattern, tone of extremities, hand and foot activity, and level of activity. The lowest and the highest scores obtainable from the scale are 0 and 10, respectively. As the score increases, stress and pain increase.
Crying time in second
Time frame: 12 week
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 7 Jul 2022.
- Derived from this study: PubMed 41254729Kadiroglu T, Guven M, Yalcin R, Aslan A. The effects of manual and automatic lancet use on pain, stress, physiological parameters and crying duration during capillary heel blood collection in term neonates: a randomized controlled trial. BMC Nurs. 2025 Nov 18;24(1):1409. doi: 10.1186/s12912-025-04056-y.
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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 Automatic lancet in people with Newborn and Pain, run by Ataturk 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 5 inclusion and 1 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 7 Jul 2022. 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?
The neo pain assessment scale (time frame: 12 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05448508, which also lists 1 linked publication.
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 7 Jul 2022.