PainNCT06607575
The Effect of Warming and Vibration Applications on Pain in Newborns
A study testing Warming, Vibration and Warming and vibration in people with Pain, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial summary
This study aimed to determine the effects of warming and vibration applications on pain during heel blood collection in newborns. H1: Warming application has a positive effect on pain during heel blood collection in newborns. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Warming, Vibration and Warming and vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 12 Mar 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborns
Who cannot join
- Newborns with any lower extremity anomalies
- Newborns with congenital diseases
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Acıbadem University
Istanbul, Ata
Acıbadem University
Istanbul, Ataşehir, 34750
About this study
Official title: The Effect of Warming and Vibration Applications on Pain During Heel Blood Collection in Newborns
This study aimed to determine the effects of warming and vibration applications on pain during heel blood collection in newborns.
H1: Warming application has a positive effect on pain during heel blood collection in newborns.
H2: Vibration application has a positive effect on pain during heel blood collection in newborns.
H3: The combined application of warming and vibration during heel blood collection in newborns has a positive effect on pain.
Read the detailed description
Heel blood collection is frequently used for neonatal metabolic screening and analysis of bilirubin, glucose and other biochemical/hematologic parameters. This process is both painful and stressful for the newborn. Pain experience in the neonatal period can cause intense stress in the infant and cause physiopathological changes such as respiratory irregularity, impaired thermoregulation, changes in heart rhythm, changes in oxygen saturation and blood pressure. Therefore, it is recommended to use evidence-based non-pharmacological methods to reduce the pain experiences of newborns and to minimize the short and long-term negative effects of pain.
Based on this rationale, this study was planned to evaluate the effect of non-pharmacologic methods on pain and procedure time together.
- Conditions
- Pain
- Being tested
- Control group, Warming, Vibration, Warming and vibration
- Keywords
- Newborn, pain, vibration, warming, heel blood collection, infant
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
- The procedure for heel blood collection will be performed.
- Pain assessment will be performed with the N-PASS scale during and after the procedure.
WarmingOther
- The cotton sock will be warmed under the heater for 3 minutes. The sock will be put on the newborn and taken off after 3 minutes.
- The procedure for heel blood collection will be performed.
- Pain assessment will be performed with the N-PASS scale during and after the procedure.
VibrationOther
- A rechargeable toothbrush will be prepared for the newborn to whom vibration will be applied. The vibration process will be applied to the midline of the gastrocnemius muscle for 3 minutes.
- The procedure for heel blood collection will be performed.
- Pain assessment will be performed with the N-PASS scale during and after the procedure.
Warming and vibrationOther
- After the socks are warmed, they will be put on the newborn\'s feet and both warming and vibration will be applied for 3 minutes.
- The procedure for heel blood collection will be performed.
- Pain assessment will be performed with the N-PASS scale during and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Newborns who will be subjected to routine practices during heel blood collection procedure and who will not be subjected to warming and vibration will constitute the control group. Receives: Other: Control group |
| Experimental group (warming) | Experimental | Newborns who will be subjected to warming application during the heel blood collection procedure will constitute the 1st experimental group. Receives: Other: Warming |
| Experimental group (vibration) | Experimental | Newborns who will be subjected to vibration during the heel blood collection procedure will constitute the 2nd experimental group. Receives: Other: Vibration |
| Experimental group (warming and vibration) | Experimental | Newborns who will be subjected to both warming and vibration during the heel blood collection procedure will constitute the 3rd experimental group. Receives: Other: Warming and vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of pain
The level of pain will be measured using the N-PASS: Neonatal Pain/Agitation, Sedation Scale. The scale was developed by Hummel, Lawlor-Klean and Weiss in 2010, its Turkish validity and reliability were made by Açıkgöz et al. in 2017. N-PASS consists of two sections: sedation and pain assessment. Total pain score varies between 0 and +11 and total sedation score varies between 0 and +10. A high score indicates severe pain. The aim is to keep the score at 3 and below. If it is above 3 points, sedation requirements are evaluated. The average time spent to administer the scale is 1 minute.
Measured: Immediately before the prosedure, during the procedure, immediately after the procedure. The change in these time period will be measured.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start15 Oct 2024
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
- Investigators
- Hande Keskin Nurse, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607575
- Sponsor's protocol ID
- ATADEK 2023-10/403
- Status last verified
- Mar 2025
- First submitted
- 19 Sep 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avan Antepli N, Bilsin Kocamaz E, Gungormus Z. The Effect of Vibration on Pain During Heel Lance Procedures in Newborns: A Randomized Controlled Trial. Adv Neonatal Care. 2022 Apr 1;22(2):E43-E47. doi: 10.1097/ANC.0000000000000918.
PubMed 34334677Shepherd AJ, Glenesk A, Niven CA, Mackenzie J. A Scottish study of heel-prick blood sampling in newborn babies. Midwifery. 2006 Jun;22(2):158-68. doi: 10.1016/j.midw.2005.07.002. Epub 2005 Dec 28.
PubMed 16386341Ray R, Godwin Y, Shepherd A. Convective burn from use of hairdryer for heel warming prior to the heel prick test - a case report. BMC Pediatr. 2011 May 10;11:30. doi: 10.1186/1471-2431-11-30.
PubMed 21569274Napiorkowska-Orkisz M, Gutysz-Wojnicka A, Tanajewska M, Sadowska-Krawczenko I. Evaluation of Methods to Minimize Pain in Newborns during Capillary Blood Sampling for Screening: A Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Jan 13;19(2):870. doi: 10.3390/ijerph19020870.
PubMed 35055694Hassan Z, Shah M. Scald injury from the Guthrie test: should the heel be warmed? Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F533-4. doi: 10.1136/adc.2005.072678.
PubMed 16244215
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Warming and Vibration Applications on Pain During Heel Blood Collection in Newborns
- ClinicalTrials.gov ID
- NCT06607575
- Acronym / sponsor ID
- ATADEK 2023-10/403
- Conditions
- Pain
- Keywords
- Newborn, pain, vibration, warming, heel blood collection, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 23 Sep 2024 (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 study aimed to determine the effects of warming and vibration applications on pain during heel blood collection in newborns.
H1: Warming application has a positive effect on pain during heel blood collection in newborns.
H2: Vibration application has a positive effect on pain during heel blood collection in newborns.
H3: The combined application of warming and vibration during heel blood collection in newborns has a positive effect on pain.
Detailed description
Heel blood collection is frequently used for neonatal metabolic screening and analysis of bilirubin, glucose and other biochemical/hematologic parameters. This process is both painful and stressful for the newborn. Pain experience in the neonatal period can cause intense stress in the infant and cause physiopathological changes such as respiratory irregularity, impaired thermoregulation, changes in heart rhythm, changes in oxygen saturation and blood pressure. Therefore, it is recommended to use evidence-based non-pharmacological methods to reduce the pain experiences of newborns and to minimize the short and long-term negative effects of pain.
Based on this rationale, this study was planned to evaluate the effect of non-pharmacologic methods on pain and procedure time together.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Control groupNewborns who will be subjected to routine practices during heel blood collection procedure and who will not be subjected to warming and vibration will constitute the control group. |
| Experimental group (warming) | Experimental | Other: WarmingNewborns who will be subjected to warming application during the heel blood collection procedure will constitute the 1st experimental group. |
| Experimental group (vibration) | Experimental | Other: VibrationNewborns who will be subjected to vibration during the heel blood collection procedure will constitute the 2nd experimental group. |
| Experimental group (warming and vibration) | Experimental | Other: Warming and vibrationNewborns who will be subjected to both warming and vibration during the heel blood collection procedure will constitute the 3rd experimental group. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy newborns
Key exclusion criteria (2 listed)
- Newborns with any lower extremity anomalies
- Newborns with congenital diseases
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 |
|---|---|---|
| Control group1. The procedure for heel blood collection will be performed. 2. Pain assessment will be performed with the N-PASS scale during and after the procedure. | Other | Control group |
| Warming1. The cotton sock will be warmed under the heater for 3 minutes. The sock will be put on the newborn and taken off after 3 minutes. 2. The procedure for heel blood collection will be performed. 3. Pain assessment will be performed with the N-PASS scale during and after the procedure. | Other | Experimental group (warming) |
| Vibration1. A rechargeable toothbrush will be prepared for the newborn to whom vibration will be applied. The vibration process will be applied to the midline of the gastrocnemius muscle for 3 minutes. 2. The procedure for heel blood collection will be performed. 3. Pain assessment will be performed with the N-PASS scale during and after the procedure. | Other | Experimental group (vibration) |
| Warming and vibration1. After the socks are warmed, they will be put on the newborn\'s feet and both warming and vibration will be applied for 3 minutes. 2. The procedure for heel blood collection will be performed. 3. Pain assessment will be performed with the N-PASS scale during and after the procedure. | Other | Experimental group (warming and vibration) |
Primary outcome
Change in level of pain
Time frame: Immediately before the prosedure, during the procedure, immediately after the procedure. The change in these time period will be measured.
The level of pain will be measured using the N-PASS: Neonatal Pain/Agitation, Sedation Scale. The scale was developed by Hummel, Lawlor-Klean and Weiss in 2010, its Turkish validity and reliability were made by Açıkgöz et al. in 2017. N-PASS consists of two sections: sedation and pain assessment. Total pain score varies between 0 and +11 and total sedation score varies between 0 and +10. A high score indicates severe pain. The aim is to keep the score at 3 and below. If it is above 3 points, sedation requirements are evaluated. The average time spent to administer the scale is 1 minute.
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 15 Sep 2026.
- Results publication: PubMed 34334677Avan Antepli N, Bilsin Kocamaz E, Gungormus Z. The Effect of Vibration on Pain During Heel Lance Procedures in Newborns: A Randomized Controlled Trial. Adv Neonatal Care. 2022 Apr 1;22(2):E43-E47. doi: 10.1097/ANC.0000000000000918.
- Results publication: PubMed 16386341Shepherd AJ, Glenesk A, Niven CA, Mackenzie J. A Scottish study of heel-prick blood sampling in newborn babies. Midwifery. 2006 Jun;22(2):158-68. doi: 10.1016/j.midw.2005.07.002. Epub 2005 Dec 28.
- Results publication: PubMed 21569274Ray R, Godwin Y, Shepherd A. Convective burn from use of hairdryer for heel warming prior to the heel prick test - a case report. BMC Pediatr. 2011 May 10;11:30. doi: 10.1186/1471-2431-11-30.
- Results publication: PubMed 35055694Napiorkowska-Orkisz M, Gutysz-Wojnicka A, Tanajewska M, Sadowska-Krawczenko I. Evaluation of Methods to Minimize Pain in Newborns during Capillary Blood Sampling for Screening: A Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Jan 13;19(2):870. doi: 10.3390/ijerph19020870.
- Results publication: PubMed 16244215Hassan Z, Shah M. Scald injury from the Guthrie test: should the heel be warmed? Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F533-4. doi: 10.1136/adc.2005.072678.
- Individual participant dataSharing planned: No
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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.
Hande Keskin Nurse principal investigator
Acibadem University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warming, Vibration and Warming and vibration in people with Pain, run by Acibadem University at 2 sites 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 1 inclusion and 2 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in level of pain (time frame: Immediately before the prosedure, during the procedure, immediately after the procedure. The change in these time period will be measured.). 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 NCT06607575, which also lists 5 linked publications.
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 15 Sep 2026.