Heel Lance ProceduresNCT07348731
Non-Pharmacological Methods in Heel Lance
A study testing Foot bath in people with Heel Lance Procedures, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the… Read more about this study
- Who is it for?
- Ages 4 days to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Heel Lance Procedures
- What is being tested?
- Foot bath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2026to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 days to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns with a gestational age of ≥37 weeks
- Newborns in the neonatal period (0-28 days)
- Stable vital signs
- Obtained informed consent from the parents
- No use of analgesics or sedatives within the 24 hours before the procedure
- Absence of any respiratory problems
- First-time heel lance procedure
- No condition that would interfere with pain assessment
Who cannot join
- Preterm or low birth weight infants (< 2500 g)
- Infants with congenital anomalies or requiring respiratory support
- Infants receiving sedative or analgesic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atlas University
Istanbul, Kağıthane, 34098
About this study
Official title: Comparison of the Effects of Foot Bath, ShotBlocker®, and Buzzy® on Neonatal Vital Signs During Heel Lance
This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care.
Data will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.
Read the detailed description
This study was designed to investigate the effects of three different non-pharmacological interventions applied prior to heel lance on the vital parameters and pain levels of newborns. The study population consists of term newborns who meet the inclusion criteria, and the sample includes newborns who present with their parents to a state hospital for heel lance and meet these criteria. Following ethical approval, data will be collected between November 2025 and November 2026. Data collection will be carried out by Özlem Kum, a graduate student actively working in the relevant clinic and responsible for performing the procedures.
Pain will be assessed using the Neonatal Infant Pain Scale (NIPS), which evaluates procedural pain in both preterm and term newborns. The scale includes five behavioral indicators (facial expression, leg movement, arm movement, crying, and state of arousal) and one physiological indicator (respiratory pattern), with total scores ranging from 0 to 7. A 16-item Information Form containing maternal and neonatal characteristics will also be used. Statistical analyses will be performed using SPSS version 26, including frequency, percentage, mean, standard deviation, t-test, ANOVA, and Pearson correlation analyses.
Heel lance is one of the most frequently performed invasive procedures in the neonatal period. The pain and stress experienced during this procedure may lead to changes in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management strategies is essential for improving the quality of nursing care.
Non-pharmacological methods such as warm foot bath, ShotBlocker®, and the Buzzy® device are commonly used to reduce procedural pain through different mechanisms, including increased peripheral circulation, mechanical stimulation, vibration, and cold application. However, studies comparing the effects of these methods on newborns' heart rate, respiratory rate, oxygen saturation, and pain levels are limited.
This study will be conducted with approximately 90 clinically stable term newborns (37-42 weeks of gestation) in the Neonatal Unit of Kocaeli City Hospital. Data will be collected at three time points-before, during, and after the procedure-and changes in heart rate, respiratory rate, and oxygen saturation will be recorded. With parental consent, the procedure will be video-recorded at all stages, and anonymized recordings will be shared with experts for pain assessment.
The findings of this study are expected to contribute to the identification of effective non-pharmacological methods that can be used during painful procedures such as heel lance and to support the development of evidence-based practices in neonatal nursing.
- Conditions
- Heel Lance Procedures
- Being tested
- Foot bath
- Keywords
- Foot Bath, Buzzy, Shotblocker, heel lance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot bathBehavioural
The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes.
The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine.
The video recording will be stopped once bleeding has ceased at the end of the procedure.
The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.
| Study group | Role | What they receive |
|---|---|---|
| Buzzy | Experimental | Vibration Application with Buzzy® Before Heel Lance Receives: Behavioral: Foot bath |
| Shotblocker | Experimental | After the information form is completed with the parent, the video recording will be initiated. The infant's vital signs will be monitored and recorded using a pulse probe, after which the ShotBlocker® will be placed on the procedure site. Following the heel lance performed with the ShotBlocker®, the time to bleeding cessation and the infant's crying duration will be recorded. Receives: Behavioral: Foot bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale
Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain) moderate pain, >4 = severe pain)
Measured: 0 minutes (T0)
Neonatal Infant Pain Scale
Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain)
Measured: 5th minutes 1st (T1)
Neonatal Infant Pain Scale
Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain)
Measured: 10th minutes (T2)
Heart Rate
beats/min.
Measured: 0 min (T0)
Heart Rate
beats/min.
Measured: 5th min 1st (T1)
Heart Rate
beats/min.
Measured: 10th minutes (T2)
Respiratory rate
respiration/minute
Measured: 0 min (T0)
Respiratory rate
respiration/minute
Measured: 5th min 1st (T1)
Respiratory rate
respiration/minute
Measured: 10th minutes (T2)
Saturation level
%100
Measured: 0 min (T0)
Saturation level
%100
Measured: 5th min 1st (T1)
Saturation level
%100
Measured: 10th minutes (T2)
Secondary outcomes (1)
The infant's crying duration
minutes
Measured: From start to end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start25 Feb 2026
- Primary completion25 Feb 2026
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel Lance ProceduresStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sermin Dinc, Atlas University
- Investigators
- sermin dinç, Dr., Principal investigator, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348731
- Sponsor's protocol ID
- E-22686390-050.99-84286
- Status last verified
- May 2026
- First submitted
- 6 Dec 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Foot Bath, ShotBlocker®, and Buzzy® on Neonatal Vital Signs During Heel Lance
- ClinicalTrials.gov ID
- NCT07348731
- Acronym / sponsor ID
- E-22686390-050.99-84286
- Conditions
- Heel Lance Procedures
- Keywords
- Foot Bath, Buzzy, Shotblocker, heel lance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 16 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.
This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care.
Data will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.
Detailed description
This study was designed to investigate the effects of three different non-pharmacological interventions applied prior to heel lance on the vital parameters and pain levels of newborns. The study population consists of term newborns who meet the inclusion criteria, and the sample includes newborns who present with their parents to a state hospital for heel lance and meet these criteria. Following ethical approval, data will be collected between November 2025 and November 2026. Data collection will be carried out by Özlem Kum, a graduate student actively working in the relevant clinic and responsible for performing the procedures.
Pain will be assessed using the Neonatal Infant Pain Scale (NIPS), which evaluates procedural pain in both preterm and term newborns. The scale includes five behavioral indicators (facial expression, leg movement, arm movement, crying, and state of arousal) and one physiological indicator (respiratory pattern), with total scores ranging from 0 to 7. A 16-item Information Form containing maternal and neonatal characteristics will also be used. Statistical analyses will be performed using SPSS version 26, including frequency, percentage, mean, standard deviation, t-test, ANOVA, and Pearson correlation analyses.
Heel lance is one of the most frequently performed invasive procedures in the neonatal period. The pain and stress experienced during this procedure may lead to changes in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management strategies is essential for improving the quality of nursing care.
Non-pharmacological methods such as warm foot bath, ShotBlocker®, and the Buzzy® device are commonly used to reduce procedural pain through different mechanisms, including increased peripheral circulation, mechanical stimulation, vibration, and cold application. However, studies comparing the effects of these methods on newborns' heart rate, respiratory rate, oxygen saturation, and pain levels are limited.
This study will be conducted with approximately 90 clinically stable term newborns (37-42 weeks of gestation) in the Neonatal Unit of Kocaeli City Hospital. Data will be collected at three time points-before, during, and after the procedure-and changes in heart rate, respiratory rate, and oxygen saturation will be recorded. With parental consent, the procedure will be video-recorded at all stages, and anonymized recordings will be shared with experts for pain assessment.
The findings of this study are expected to contribute to the identification of effective non-pharmacological methods that can be used during painful procedures such as heel lance and to support the development of evidence-based practices in neonatal nursing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buzzy | Experimental | Behavioral: Foot bathVibration Application with Buzzy® Before Heel Lance |
| Shotblocker | Experimental | Behavioral: Foot bathAfter the information form is completed with the parent, the video recording will be initiated. The infant's vital signs will be monitored and recorded using a pulse probe, after which the ShotBlocker® will be placed on the procedure site. Following the heel lance performed with the ShotBlocker®, the time to bleeding cessation and the infant's crying duration will be recorded. |
Who may qualify
- Ages
- 4 days to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Newborns with a gestational age of ≥37 weeks
- Newborns in the neonatal period (0-28 days)
- Stable vital signs
- Obtained informed consent from the parents
- No use of analgesics or sedatives within the 24 hours before the procedure
Key exclusion criteria (3 listed)
- Preterm or low birth weight infants (< 2500 g)
- Infants with congenital anomalies or requiring respiratory support
- Infants receiving sedative or analgesic treatment
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 |
|---|---|---|
| Foot bathThe infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes. The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine. The video recording will be stopped once bleeding has ceased at the end of the procedure. The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts. | Behavioural | Buzzy, Shotblocker |
Primary outcome
Neonatal Infant Pain Scale
Time frame: 0 minutes (T0)
Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain) moderate pain, >4 = severe pain)
Neonatal Infant Pain Scale
Time frame: 5th minutes 1st (T1)
Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain)
Neonatal Infant Pain Scale
Time frame: 10th minutes (T2)
Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain)
Heart Rate
Time frame: 0 min (T0)
beats/min.
Heart Rate
Time frame: 5th min 1st (T1)
beats/min.
Heart Rate
Time frame: 10th minutes (T2)
beats/min.
Respiratory rate
Time frame: 0 min (T0)
respiration/minute
Respiratory rate
Time frame: 5th min 1st (T1)
respiration/minute
Respiratory rate
Time frame: 10th minutes (T2)
respiration/minute
Saturation level
Time frame: 0 min (T0)
%100
Saturation level
Time frame: 5th min 1st (T1)
%100
Saturation level
Time frame: 10th minutes (T2)
%100
1 secondary outcome
The infant's crying duration
Time frame: From start to end of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- The effect of the ShotBlocker® and breastfeeding on pain and comfort level during heel lance procedure in newborns: randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Heel Lance Procedures
Not yet recruiting
Crochet Octopus in Reducing Procedural Pain During Heel Lance in Preterm Neonates
Preterm Neonates, Heel Lance Procedures
Not yet recruiting
The Effect of Su Jok Therapy on Pain During Heel LanceProcedure in Newborn
Heel Lance Procedures, Pain Management
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.
sermin dinç, Dr. principal investigator
Atlas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot bath in people with Heel Lance Procedures, run by Atlas 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sermin Dinc, Dr. (5424033430 ext. +90, sermin.dinc@atlas.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Infant Pain Scale (time frame: 0 minutes (T0)). The study lists 12 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 2 Jun 2026.