Procedural PainNCT06380556
The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates
A study testing ShotBlocker and Mechanical vibration in people with Procedural Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants. Read more about this study
- Who is it for?
- Ages 38 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain
- What is being tested?
- ShotBlocker and Mechanical vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2022to 13 Jul 2023
- 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 38 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- with a postnatal age of 24-72 hours,
- birth weight of 2500 g and above,
- 5th minute APGAR score above 6,
- able to carry out vital activities without support,
- fed within one hour before the procedure,
- calm and not crying before the procedure,
- babies who had heel prick for the first time
Who cannot join
- with genetic or congenital anomaly,
- with neurological, cardiological and metabolic diseases,
- in need of respiratory support,
- having a history of sedative, analgesic, or narcotic use within 24 h before admission,
- hospitalization and surgical procedure experience in neonatal intensive care unit,
- experience with needle interventions other than vitamin K and Hepatitis B vaccine,
- babies of mothers with a history of substance abuse
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University
Istanbul, Kadıköy, 34720
About this study
Official title: The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates: A Randomized Controlled Trial
This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants.
Read the detailed description
Heel prick blood collection, which is one of the painful medical procedures, is one of the diagnostic methods used in newborns and is a more painful procedure compared to other blood collection procedures. Prevention of pain in newborns should be the primary goal of all healthcare personnel working with newborns, both because it is an ethical obligation and because repeated painful exposures have the potential to cause harmful consequences. Nonpharmacologic methods used for the control of acute pain associated with medical procedures are easy to use, have no side effects, are inexpensive and time-saving. Mechanical vibration and ShotBlocker application are among the non-pharmacologic methods frequently used in the management of pain associated with heel prick procedure in term infants.
Previous studies have shown that parent-related methods (kangaroo care, mother/father hug, breastfeeding, etc.) are commonly used for pain management of the newborn during heel prick. In this respect, it is important to determine the effectiveness of mechanical vibration and ShotBlocker methods that can be used independently of the parent, especially in intensive care settings where access to the parent is not always possible.
- Conditions
- Procedural Pain
- Being tested
- ShotBlocker, Mechanical vibration
- Keywords
- Procedural pain, Term neonate, Nonpharmacological pain management
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlockerDevice
The protruding surface of the ShotBlocker was placed on the heel lance procedure site. While applying pressure on the skin through the ShotBlocker, the nurse performed heel lancing with the needle through the opening in the center of the ShotBlocker. During the 10-second waiting phase, the ShotBlocker was kept at the procedure site with the same pressure. Then ShotBlocker was removed from the skin and routine capillary blood collection procedure was performed.
Mechanical vibrationDevice
The vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes. The device was secured to the extremity with a gauze bandage. The vibration device was operated for 30 seconds with reference to previous studies. While the vibration continued, the nurse punctured the heel with a needle. Then, the vibration device continued to work in the waiting phase for 10 seconds. The vibration device was removed from the baby's extremity and routine capillary blood collection procedure was performed.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The heel lance procedure of the infants in the control group was performed according to the routine heel lance procedure of the clinic. |
| ShotBlocker | Experimental | ShotBlocker was applied to the infants in this group before and during the heel lance procedure. Receives: Device: ShotBlocker |
| Mechanical vibration | Experimental | Mechanical vibration was applied to the infants in this group before and during the heel lance procedure. Receives: Device: Mechanical vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural pain score- Neonatal Infant Pain Scale (NIPS)
The scale is used to assess procedural pain in neonates. It is a behavioral scale assessing five behavioral indicators (facial expression, cry, arms, legs, and state of alertness) and one physiological indicator (breathing patterns). Five items (facial expression, breathing pattern, arms, legs, and state of alertness) are scored as 0 (Good) or 1 (Bad), while one item (crying) is scored as 0 (Good), 1, or 2 (Bad). The total scale score ranges from 0 to 7, with higher scores indicating more pain.
Measured: 1 min before the heel lance procedure (T-1 min), during the procedure (T+0 sec), 2 min (T+2 min) and 5 min (T+5 min) after the procedure; an average of 6 minutes
Secondary outcomes (2)
Crying time
Crying time is the crying time between the moment of heel puncture and 5 minutes after the procedure.
Measured: Through painful procedure completion, an average of 5 minutes
Procedure time
The duration of the procedure is the time between the moment of heel lance and the closure of the heel with gauze after the collection of capillary blood.
Measured: Through painful procedure completion, an average of 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start10 Nov 2022
- Primary completion30 Jan 2023
- Study completion13 Jul 2023
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 Procedural PainStudies 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
- Model description
- In the study, participants were assigned to groups by block randomization. Type of delivery (vaginal and cesarean section), gender (male and female) and birth weight (2500-3000 g, 3001-3500 g, 3501 and above) variables were used for block randomization. Blocks were repeated three times in each group and 36 participants were assigned to each. A randomization list with 2 X 2 X 3 X 3 blocks was developed using an online randomization tool. In the study, the group to which the first participant was assigned was determined by a sealed envelope method.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Aytekin Ozdemir, Istanbul Medeniyet University
- Investigators
- Aynur Aytekin Özdemir, PhD, Study director, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380556
- Sponsor's protocol ID
- 25.05.2022/68
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
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 34334677McGinnis K, Murray E, Cherven B, McCracken C, Travers C. Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial. Adv Neonatal Care. 2016 Dec;16(6):439-448. doi: 10.1097/ANC.0000000000000315.
PubMed 27533335Baba LR, McGrath JM, Liu J. The efficacy of mechanical vibration analgesia for relief of heel stick pain in neonates: a novel approach. J Perinat Neonatal Nurs. 2010 Jul-Sep;24(3):274-83. doi: 10.1097/JPN.0b013e3181ea7350.
PubMed 20697246Caglar S, Buyukyilmaz F, Cosansu G, Caglayan S. Effectiveness of ShotBlocker for Immunization Pain in Full-Term Neonates: A Randomized Controlled Trial. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):166-171. doi: 10.1097/JPN.0000000000000256.
PubMed 28437308Catal RA, Ozdemir AA, Karatekin G. Effect of mechanical vibration and ShotBlocker(R) on pain levels during heel lance in healthy term neonates: A randomized controlled trial. J Pediatr Nurs. 2024 Nov-Dec;79:e51-e59. doi: 10.1016/j.pedn.2024.09.019. Epub 2024 Oct 11.
PubMed 39394025
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06380556
- Acronym / sponsor ID
- 25.05.2022/68
- Conditions
- Procedural Pain
- Keywords
- Procedural pain, Term neonate, Nonpharmacological pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 24 Apr 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 was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants.
Detailed description
Heel prick blood collection, which is one of the painful medical procedures, is one of the diagnostic methods used in newborns and is a more painful procedure compared to other blood collection procedures. Prevention of pain in newborns should be the primary goal of all healthcare personnel working with newborns, both because it is an ethical obligation and because repeated painful exposures have the potential to cause harmful consequences. Nonpharmacologic methods used for the control of acute pain associated with medical procedures are easy to use, have no side effects, are inexpensive and time-saving. Mechanical vibration and ShotBlocker application are among the non-pharmacologic methods frequently used in the management of pain associated with heel prick procedure in term infants.
Previous studies have shown that parent-related methods (kangaroo care, mother/father hug, breastfeeding, etc.) are commonly used for pain management of the newborn during heel prick. In this respect, it is important to determine the effectiveness of mechanical vibration and ShotBlocker methods that can be used independently of the parent, especially in intensive care settings where access to the parent is not always possible.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- In the study, participants were assigned to groups by block randomization. Type of delivery (vaginal and cesarean section), gender (male and female) and birth weight (2500-3000 g, 3001-3500 g, 3501 and above) variables were used for block randomization. Blocks were repeated three times in each group and 36 participants were assigned to each. A randomization list with 2 X 2 X 3 X 3 blocks was developed using an online randomization tool. In the study, the group to which the first participant was assigned was determined by a sealed envelope method.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The heel lance procedure of the infants in the control group was performed according to the routine heel lance procedure of the clinic. |
| ShotBlocker | Experimental | Device: ShotBlockerShotBlocker was applied to the infants in this group before and during the heel lance procedure. |
| Mechanical vibration | Experimental | Device: Mechanical vibrationMechanical vibration was applied to the infants in this group before and during the heel lance procedure. |
Who may qualify
- Ages
- 38 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- with a postnatal age of 24-72 hours,
- birth weight of 2500 g and above,
- 5th minute APGAR score above 6,
- able to carry out vital activities without support,
- fed within one hour before the procedure,
Key exclusion criteria (7 listed)
- with genetic or congenital anomaly,
- with neurological, cardiological and metabolic diseases,
- in need of respiratory support,
- having a history of sedative, analgesic, or narcotic use within 24 h before admission,
- hospitalization and surgical procedure experience in neonatal intensive care unit,
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 |
|---|---|---|
| ShotBlockerThe protruding surface of the ShotBlocker was placed on the heel lance procedure site. While applying pressure on the skin through the ShotBlocker, the nurse performed heel lancing with the needle through the opening in the center of the ShotBlocker. During the 10-second waiting phase, the ShotBlocker was kept at the procedure site with the same pressure. Then ShotBlocker was removed from the skin and routine capillary blood collection procedure was performed. | Device | ShotBlocker |
| Mechanical vibrationThe vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes. The device was secured to the extremity with a gauze bandage. The vibration device was operated for 30 seconds with reference to previous studies. While the vibration continued, the nurse punctured the heel with a needle. Then, the vibration device continued to work in the waiting phase for 10 seconds. The vibration device was removed from the baby's extremity and routine capillary blood collection procedure was performed. | Device | Mechanical vibration |
Primary outcome
Procedural pain score- Neonatal Infant Pain Scale (NIPS)
Time frame: 1 min before the heel lance procedure (T-1 min), during the procedure (T+0 sec), 2 min (T+2 min) and 5 min (T+5 min) after the procedure; an average of 6 minutes
The scale is used to assess procedural pain in neonates. It is a behavioral scale assessing five behavioral indicators (facial expression, cry, arms, legs, and state of alertness) and one physiological indicator (breathing patterns). Five items (facial expression, breathing pattern, arms, legs, and state of alertness) are scored as 0 (Good) or 1 (Bad), while one item (crying) is scored as 0 (Good), 1, or 2 (Bad). The total scale score ranges from 0 to 7, with higher scores indicating more pain.
2 secondary outcomes
Crying time
Time frame: Through painful procedure completion, an average of 5 minutes
Procedure time
Time frame: Through painful procedure completion, an average of 2 minutes
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 24 Apr 2024.
- Background: 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.
- Background: PubMed 27533335McGinnis K, Murray E, Cherven B, McCracken C, Travers C. Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial. Adv Neonatal Care. 2016 Dec;16(6):439-448. doi: 10.1097/ANC.0000000000000315.
- Background: PubMed 20697246Baba LR, McGrath JM, Liu J. The efficacy of mechanical vibration analgesia for relief of heel stick pain in neonates: a novel approach. J Perinat Neonatal Nurs. 2010 Jul-Sep;24(3):274-83. doi: 10.1097/JPN.0b013e3181ea7350.
- Background: PubMed 28437308Caglar S, Buyukyilmaz F, Cosansu G, Caglayan S. Effectiveness of ShotBlocker for Immunization Pain in Full-Term Neonates: A Randomized Controlled Trial. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):166-171. doi: 10.1097/JPN.0000000000000256.
- Derived from this study: PubMed 39394025Catal RA, Ozdemir AA, Karatekin G. Effect of mechanical vibration and ShotBlocker(R) on pain levels during heel lance in healthy term neonates: A randomized controlled trial. J Pediatr Nurs. 2024 Nov-Dec;79:e51-e59. doi: 10.1016/j.pedn.2024.09.019. Epub 2024 Oct 11.
- Individual participant dataSharing planned: Yes. Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
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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.
Aynur Aytekin Özdemir, PhD study director
Istanbul Medeniyet 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 ShotBlocker and Mechanical vibration in people with Procedural Pain, run by Istanbul Medeniyet 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 7 inclusion and 7 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 24 Apr 2024. 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?
Procedural pain score- Neonatal Infant Pain Scale (NIPS) (time frame: 1 min before the heel lance procedure (T-1 min), during the procedure (T+0 sec), 2 min (T+2 min) and 5 min (T+5 min) after the procedure; an average of 6 minutes). 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 NCT06380556, 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 24 Apr 2024.