Procedural PainNCT06377748
The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants
A study testing Facilitated tucking position, ShotBlocker and Combined facilitated tucking and ShotBlocker in people with Procedural Pain and Pain, Acute, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration 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, Pain, Acute, Nursing Caries
- What is being tested?
- Facilitated tucking position, ShotBlocker and Combined facilitated tucking and ShotBlocker
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 30 Sep 2024
- 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
- healthy term neonates
- born at 38-42 weeks gestational week,
- birth weight 2500-4400 g,
- 5th minute APGAR score above 6,
- in stable health,
- able to carry out vital activities without support,
- babies ordered Hepatitis B vaccine by the doctor
Who cannot join
- With a genetic or congenital anomaly,
- neurological, cardiological and metabolic diseases,
- in need of respiratory support,
- acute or chronic illness that causes pain,
- a complication of childbirth,
- infants of hepatitis B carrier mothers,
- nerve damage or deformity in the extremity to be vaccinated, scar tissue or incision in the vastus lateralis region,
- infants 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 Facilitated-tucking, ShotBlocker, and the Combination of the Facilitated-tucking and ShotBlocker on Pain Caused by Hepatitis-B Vaccination in Healthy Term Infants: Randomized Controlled Study
This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.
Read the detailed description
Hepatitis B vaccination is one of the painful procedures routinely performed in newborns. The pain experienced by the newborn negatively affects the prognosis of the disease, the infant's behavior, the harmony with the environment, the development of the brain and senses, as well as the family-infant interaction. Nonpharmacologic methods have been found to be effective in alleviating pain during interventions that cause pain caused by medical procedures that newborns frequently encounter. Facilitated tucking and ShotBlocker are effective methods that can be used in nonpharmacologic procedural pain management.
Studies have commonly used parent-related methods (kangaroo care, mother/father cuddling, breastfeeding, etc.) for neonatal pain management during Hepatitis B vaccine administration. In units where access to the parent is not always possible, nonpharmacologic pain methods that can be used independently of the parent can be used in the management of acute needle-related pain. In addition, no study was found in the literature comparing and combining the effect of fetal position and ShotBlocker application on hepatitis B vaccine-related pain. This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.
- Conditions
- Procedural Pain, Pain, Acute, Nursing Caries
- Being tested
- Facilitated tucking position, ShotBlocker, Combined facilitated tucking and ShotBlocker
- Keywords
- Healthy infant, Nonpharmacological pain management, Procedural pain
- Medical subject headings
- Pain, Procedural, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated tucking positionOther
Also called Positioning
Neonates in this group will be given facilitated tucking position (lower and upper extremities will be held in right lateral flexion position and midline) by a volunteer nurse one minute before the vaccination procedure. The nurse will administer intramuscular vaccine injection into the vastus lateralis region of the left leg of the infant in the facilitated tucking position according to routine practice.
ShotBlockerDevice
Immediately prior to the vaccination procedure, the nurse will place the protruding surface of the ShotBlocker on the neonate's vaccination procedure site (left leg vastus lateralis muscle). The nurse will continue to hold the ShotBlocker at the injection site by pressing against the skin for 20 seconds. At the end of the time, she will grasp the tissue with the ShotBlocker and inject the vaccine through the opening in the center. After the procedure is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin.
Combined facilitated tucking and ShotBlockerCombination product
Neonates in this group will be given facilitated tucking position (lower and upper extremities will be held in right lateral flexion position and midline) by a volunteer nurse one minute before the vaccination procedure. The nurse will place the ShotBlocker on the procedure site and apply pressure to the skin for 20 seconds. At the end of the time, the nurse will grasp the tissue with the ShotBlocker and inject the vaccine through the central opening. After the injection is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin. The newborn will continue to take facilitated tucking position until 1 minute after the ShotBlocker is removed.
| Study group | Role | What they receive |
|---|---|---|
| Facilitated tucking position | Experimental | Newborns in this group will take the facilitated tucking position during routine Hepatitis B vaccine administration. Receives: Other: Facilitated tucking position |
| ShotBlocker | Experimental | ShotBlocker will be used during routine Hepatitis B vaccine administration of newborns in this group. Receives: Device: ShotBlocker |
| Combined facilitated tucking position and ShotBlocker | Experimental | Neonates in this group will take facilitated tucking position during routine Hepatitis B vaccine administration and ShotBlocker will be used during the procedure. Receives: Combination Product: Combined facilitated tucking and ShotBlocker |
| Control | No intervention | The control group will receive routine Hepatitis B vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale
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, during, 1 min after and 3 min after the painful procedure, an average of 4-5 minutes
Secondary outcomes (2)
Crying time during the procedure
Total crying time during the procedure is the time the newborn cries between 1 min before and 3 min after the painful procedure.
Measured: Through painful procedure completion, an average of 4 minutes
Procedure time
For vaccine administration, it is the time between when the needle is inserted into the skin and when it is removed from the skin.
Measured: Through painful procedure completion, an average of 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start15 Jun 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Participants will be assigned to experimental and control groups using block randomization method. Birth weight (2500-3000 g, 3001-3500 g, 3501 g and above), gender (male and female) and mode of delivery (vaginal and cesarean section) variables will be used for block randomization.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 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
- NCT06377748
- Sponsor's protocol ID
- 2023/02
- Status last verified
- Oct 2024
- First submitted
- 17 Apr 2024
- Last updated
- 16 Oct 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
Avcin E, Kucukoglu S. The Effect of Breastfeeding, Kangaroo Care, and Facilitated Tucking Positioning in Reducing the Pain During Heel Stick in Neonates. J Pediatr Nurs. 2021 Nov-Dec;61:410-416. doi: 10.1016/j.pedn.2021.10.002. Epub 2021 Oct 20.
PubMed 34687988Caglar 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 28437308Drago LA, Singh SB, Douglass-Bright A, Yiadom MY, Baumann BM. Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. Am J Emerg Med. 2009 Jun;27(5):536-43. doi: 10.1016/j.ajem.2008.04.011.
PubMed 19497458Kucukoglu S, Kurt S, Aytekin A. The effect of the facilitated tucking position in reducing vaccination-induced pain in newborns. Ital J Pediatr. 2015 Aug 21;41:61. doi: 10.1186/s13052-015-0168-9.
PubMed 26293573
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Facilitated-tucking, ShotBlocker, and the Combination of the Facilitated-tucking and ShotBlocker on Pain Caused by Hepatitis-B Vaccination in Healthy Term Infants: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06377748
- Acronym / sponsor ID
- 2023/02
- Conditions
- Procedural Pain, Pain, Acute, Nursing Caries
- Keywords
- Healthy infant, Nonpharmacological pain management, Procedural pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 22 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 will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.
Detailed description
Hepatitis B vaccination is one of the painful procedures routinely performed in newborns. The pain experienced by the newborn negatively affects the prognosis of the disease, the infant's behavior, the harmony with the environment, the development of the brain and senses, as well as the family-infant interaction. Nonpharmacologic methods have been found to be effective in alleviating pain during interventions that cause pain caused by medical procedures that newborns frequently encounter. Facilitated tucking and ShotBlocker are effective methods that can be used in nonpharmacologic procedural pain management.
Studies have commonly used parent-related methods (kangaroo care, mother/father cuddling, breastfeeding, etc.) for neonatal pain management during Hepatitis B vaccine administration. In units where access to the parent is not always possible, nonpharmacologic pain methods that can be used independently of the parent can be used in the management of acute needle-related pain. In addition, no study was found in the literature comparing and combining the effect of fetal position and ShotBlocker application on hepatitis B vaccine-related pain. This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be assigned to experimental and control groups using block randomization method. Birth weight (2500-3000 g, 3001-3500 g, 3501 g and above), gender (male and female) and mode of delivery (vaginal and cesarean section) variables will be used for block randomization.
| Arm | Type | Receives |
|---|---|---|
| Facilitated tucking position | Experimental | Other: Facilitated tucking positionNewborns in this group will take the facilitated tucking position during routine Hepatitis B vaccine administration. |
| ShotBlocker | Experimental | Device: ShotBlockerShotBlocker will be used during routine Hepatitis B vaccine administration of newborns in this group. |
| Combined facilitated tucking position and ShotBlocker | Experimental | Combination Product: Combined facilitated tucking and ShotBlockerNeonates in this group will take facilitated tucking position during routine Hepatitis B vaccine administration and ShotBlocker will be used during the procedure. |
| Control | No intervention | –The control group will receive routine Hepatitis B vaccination. |
Who may qualify
- Ages
- 38 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- healthy term neonates
- born at 38-42 weeks gestational week,
- birth weight 2500-4400 g,
- 5th minute APGAR score above 6,
- in stable health,
Key exclusion criteria (8 listed)
- With a genetic or congenital anomaly,
- neurological, cardiological and metabolic diseases,
- in need of respiratory support,
- acute or chronic illness that causes pain,
- a complication of childbirth,
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 |
|---|---|---|
| Facilitated tucking positionAlso: PositioningNeonates in this group will be given facilitated tucking position (lower and upper extremities will be held in right lateral flexion position and midline) by a volunteer nurse one minute before the vaccination procedure. The nurse will administer intramuscular vaccine injection into the vastus lateralis region of the left leg of the infant in the facilitated tucking position according to routine practice. | Other | Facilitated tucking position |
| ShotBlockerImmediately prior to the vaccination procedure, the nurse will place the protruding surface of the ShotBlocker on the neonate's vaccination procedure site (left leg vastus lateralis muscle). The nurse will continue to hold the ShotBlocker at the injection site by pressing against the skin for 20 seconds. At the end of the time, she will grasp the tissue with the ShotBlocker and inject the vaccine through the opening in the center. After the procedure is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin. | Device | ShotBlocker |
| Combined facilitated tucking and ShotBlockerNeonates in this group will be given facilitated tucking position (lower and upper extremities will be held in right lateral flexion position and midline) by a volunteer nurse one minute before the vaccination procedure. The nurse will place the ShotBlocker on the procedure site and apply pressure to the skin for 20 seconds. At the end of the time, the nurse will grasp the tissue with the ShotBlocker and inject the vaccine through the central opening. After the injection is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin. The newborn will continue to take facilitated tucking position until 1 minute after the ShotBlocker is removed. | Combination product | Combined facilitated tucking position and ShotBlocker |
Primary outcome
Neonatal Infant Pain Scale
Time frame: 1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 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 during the procedure
Time frame: Through painful procedure completion, an average of 4 minutes
Procedure time
Time frame: Through painful procedure completion, an average of 60 seconds
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 16 Oct 2024.
- Background: PubMed 34687988Avcin E, Kucukoglu S. The Effect of Breastfeeding, Kangaroo Care, and Facilitated Tucking Positioning in Reducing the Pain During Heel Stick in Neonates. J Pediatr Nurs. 2021 Nov-Dec;61:410-416. doi: 10.1016/j.pedn.2021.10.002. Epub 2021 Oct 20.
- 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.
- Background: PubMed 19497458Drago LA, Singh SB, Douglass-Bright A, Yiadom MY, Baumann BM. Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. Am J Emerg Med. 2009 Jun;27(5):536-43. doi: 10.1016/j.ajem.2008.04.011.
- Background: PubMed 26293573Kucukoglu S, Kurt S, Aytekin A. The effect of the facilitated tucking position in reducing vaccination-induced pain in newborns. Ital J Pediatr. 2015 Aug 21;41:61. doi: 10.1186/s13052-015-0168-9.
- 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 Facilitated tucking position, ShotBlocker and Combined facilitated tucking and ShotBlocker in people with Procedural Pain and Pain, Acute, 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 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 16 Oct 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?
Neonatal Infant Pain Scale (time frame: 1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 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 NCT06377748, which also lists 4 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 16 Oct 2024.