Heel Lance ProceduresNCT04674982
Vibration and During Heel Lance Procedures in Newborns
A study testing a vibrating device in people with Heel Lance Procedures, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns. . Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Heel Lance Procedures
- What is being tested?
- a vibrating device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2018to 12 Dec 2018
- 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 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age 38 and older
Who cannot join
- Disrupted skin integrity in the device placement site, nerve damage or -deformity of the limb from which the blood would be collected,
- Genetic and congenital anomalies
- Congenital metabolic disorders,
- those who had undergone cardiopulmonary resuscitation,
- Stayed in the neonatal intensive care unit for any reason,
- Heel blood could not be collected at the first attempt,
- Osteogenesis imperfecta
- Had been given an analgesic within the preceding 6 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vibration on Pain During Heel Lance Procedures in Newborns
This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns.
.
Read the detailed description
Methods: This randomized, controlled, experimental study. The study sample consisted of 56 newborns determined using power analysis (vibration: 28, control:28). Newborns who underwent a heel lance procedure at the specified center, whose parents agreed to participate in the study and who had reached gestational age 38 and older were enrolled in the study. In the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and continued throughout the procedure. No interventions were made on the newborns in the control group. Two nurses were employed for the heel lance procedure both for the experimental and control groups. One nurse performed the heel lance procedure for all newborns and the other nurse recorded the procedure. Pain in newborns was evaluated by the nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five minutes after the procedure, as well as by two specialists through observation of the video footage of the procedures using the NIPS. The heel lance procedure was performed by the same nurse both in the vibration and control groups.
- Conditions
- Heel Lance Procedures
- Being tested
- a vibrating device
- Keywords
- newborns, vibration, pain, heel lance
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a vibrating deviceDevice
vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz)
| Study group | Role | What they receive |
|---|---|---|
| Vibration Group | Experimental | In the vibration group, a vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz) was applied to the middle/side area through which the sural nerve passes immediately below the knee of the extremity from which heel blood was to be collected approximately 30 seconds prior to commencement of the heel lance procedure. The vibration was continued throughout the heel lance procedure unless there was redness, swelling, bruising or a change in the skin integrity in the area to which the vibration was applied, and the vibration was stopped once the procedure was over. Receives: Device: a vibrating device |
| Control Group | No intervention | No interventions were made on the newborns in the control group during the heel lance procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
G Power software was used to calculate the sample size of the study.
G Power
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start9 Sep 2018
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
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 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif BİLSİN KOCAMAZ, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674982
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 34334677
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vibration on Pain During Heel Lance Procedures in Newborns
- ClinicalTrials.gov ID
- NCT04674982
- Conditions
- Heel Lance Procedures
- Keywords
- newborns, vibration, pain, heel lance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 19 Dec 2020 (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 evaluate the effect of applying vibration on pain during heel lance procedures in newborns.
.
Detailed description
Methods: This randomized, controlled, experimental study. The study sample consisted of 56 newborns determined using power analysis (vibration: 28, control:28). Newborns who underwent a heel lance procedure at the specified center, whose parents agreed to participate in the study and who had reached gestational age 38 and older were enrolled in the study. In the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and continued throughout the procedure. No interventions were made on the newborns in the control group. Two nurses were employed for the heel lance procedure both for the experimental and control groups. One nurse performed the heel lance procedure for all newborns and the other nurse recorded the procedure. Pain in newborns was evaluated by the nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five minutes after the procedure, as well as by two specialists through observation of the video footage of the procedures using the NIPS. The heel lance procedure was performed by the same nurse both in the vibration and control groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration Group | Experimental | Device: a vibrating deviceIn the vibration group, a vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz) was applied to the middle/side area through which the sural nerve passes immediately below the knee of the extremity from which heel blood was to be collected approximately 30 seconds prior to commencement of the heel lance procedure. The vibration was continued throughout the heel lance procedure unless there was redness, swelling, bruising or a change in the skin integrity in the area to which the vibration was applied, and the vibration was stopped once the procedure was over. |
| Control Group | No intervention | –No interventions were made on the newborns in the control group during the heel lance procedure. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age 38 and older
Key exclusion criteria (8 listed)
- Disrupted skin integrity in the device placement site, nerve damage or -deformity of the limb from which the blood would be collected,
- Genetic and congenital anomalies
- Congenital metabolic disorders,
- those who had undergone cardiopulmonary resuscitation,
- Stayed in the neonatal intensive care unit for any reason,
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 |
|---|---|---|
| a vibrating devicevibrating device (Mini vibrator, 8.5 cm, 92-100 Hz) | Device | Vibration Group |
Primary outcome
G Power software was used to calculate the sample size of the study.
Time frame: 5 days
G Power
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 22 Dec 2020.
- Derived from this study: 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.
- Individual participant dataSharing planned: Undecided
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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 a vibrating device in people with Heel Lance Procedures, run by University of Gaziantep 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 1 inclusion and 8 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 22 Dec 2020. 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?
G Power software was used to calculate the sample size of the study. (time frame: 5 days). 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 NCT04674982, 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 22 Dec 2020; AzTrials last refreshed its copy on 2 Nov 2026.