Procedural PainNCT06454812
The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Infants During Vaccination
A study testing Mechanical vibration and Helfer skin tap technique (HSTT) in people with Procedural Pain and Nursing Caries, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to determine the effect of mechanical vibration and Helfer Skin Tap technique applied during intramuscular vaccinations on procedural pain level, crying time and procedure time in healthy infants. Read more about this study
- Who is it for?
- Ages 6 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Nursing Caries, Pain, Acute
- What is being tested?
- Mechanical vibration and Helfer skin tap technique (HSTT)
- Type of treatment
- Vaccines, Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 15 Dec 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 6 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy term infants
- born at 38-42 weeks gestational week,
- birth weight 2500-4400 g,
- in stable health,
- able to carry out vital activities without support,
- babies ordered third dose 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,
- nerve damage or deformity in the extremity to be vaccinated, scar tissue or incision in the vastus lateralis region.
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 Helfer Skin Tap Technique on Procedural Pain in Healthy Infants During Intramuscular Vaccination: a Randomized Controlled Study
This study will be conducted to determine the effect of mechanical vibration and Helfer Skin Tap technique applied during intramuscular vaccinations on procedural pain level, crying time and procedure time in healthy infants.
Read the detailed description
Vaccination is one of the painful procedures routinely performed in infants. The pain experienced by the infant 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 infants frequently encounter. Mechanical vibration and Helfer skin tap technique 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 vaccine administrations. 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 needle related acute pain. In addition, no study was found in the literature comparing the effect of mechanical vibration and Helfer skin tap technique on hepatitis B and DTaP-IPV-Hib vaccinations-related pain. This study will be investigated the effects of mechanical vibration and Helfer skin tap technique methods on procedural pain, crying time and duration of the procedure during intramuscular vaccinations in healthy term infants.
- Conditions
- Procedural Pain, Nursing Caries, Pain, Acute
- Being tested
- Mechanical vibration, Helfer skin tap technique (HSTT)
- 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.
Mechanical vibrationDevice
The vibration device will be placed on the procedure site (on the vastus lateralis muscle) on the left extremity and fixed through a long gauze. The vibration device will be operated for 30 seconds with reference to previous studies, then the nurse will administer routine intramuscular Hepatitis B vaccine. A gap of approximately 1-2 cm will be left between the device and the injection site. After the vaccination procedure is completed, the vibration will be terminated. The same procedure was repeated for DTaP-IPV-Hib vaccine administered to the the right extremity. The baby will be swaddled and placed in the mother's lap.
Helfer skin tap technique (HSTT)Behavioural
In this group, HSTT consisting of 4-stage strokes will be applied to the vaccination site. The nurse will make approximately 10 strokes for 5 seconds with the palmar side of the fingers of the dominant hand to the injection site to relax the muscles (Stage 1). The nurse will give a V-shaped position to the thumb and index finger of the non-dominant hand and give 3 strokes to the injection site with the palmar side of the fingers (Stage 2). The skin entry site of the needle will remain inside the V-shape. Simultaneously with the 3rd stroke, the nurse will insert the needle into the muscle at a 90 degree angle. The nurse will inject the vaccine into the muscle while continuing to tap the skin with the palmar side of the fingers of the non-dominant hand (Stage 3). The nurse will make 3 strokes on the skin with the palmar side of the fingers of the non-dominant hand at the injection site, simultaneously with the 3rd stroke, the needle will be removed from the baby's skin (Stage 4).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will receive routine vaccinations. |
| Mechanical vibration | Experimental | Mechanical vibration will be used during routine vaccination of infants in this group. Receives: Device: Mechanical vibration |
| Helfer skin tap technique | Experimental | Helfer skin tap technique will be used during routine vaccinations of infants in this group. Receives: Behavioral: Helfer skin tap technique (HSTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural pain score: FLACC Pain Scale
The FLACC scale includes the evaluation of five basic behavioural categories. The validity and reliability of the Turkish version of the Pain Diagnostic Scale (FLACC) was conducted. Each of facial expressions, leg movements, activity, crying, and consolability parameters also consists of three sub-items. The items are scored as 0, 1, and 2 point(s) respectively, with total score ranging between 0 to 10 point(s). The "0" point shows that there is no pain, 1-3 points refer to mild pain, 4-6 points refer to moderate pain, and 7-10 points refer to severe pain in infants.
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
Length of 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 posted12 Jun 2024
- Study start15 Jul 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 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. Body weight and sex variables will be used for block randomization.
- 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
- NCT06454812
- Sponsor's protocol ID
- 20.09.2023/174
- Status last verified
- Nov 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jan 2025
- 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 20697246Guven SD, Cakirer Calbayram N. The effect of Helfer skin tap technique on hepatitis B vaccine intramuscular injection pain in neonates: A randomized controlled trial. Explore (NY). 2023 Mar-Apr;19(2):238-242. doi: 10.1016/j.explore.2022.09.001. Epub 2022 Sep 8.
PubMed 36115789
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Healthy Infants During Intramuscular Vaccination: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06454812
- Acronym / sponsor ID
- 20.09.2023/174
- Conditions
- Procedural Pain, Nursing Caries, Pain, Acute
- Keywords
- Healthy infant, Nonpharmacological pain management, Procedural pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 12 Jun 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 conducted to determine the effect of mechanical vibration and Helfer Skin Tap technique applied during intramuscular vaccinations on procedural pain level, crying time and procedure time in healthy infants.
Detailed description
Vaccination is one of the painful procedures routinely performed in infants. The pain experienced by the infant 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 infants frequently encounter. Mechanical vibration and Helfer skin tap technique 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 vaccine administrations. 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 needle related acute pain. In addition, no study was found in the literature comparing the effect of mechanical vibration and Helfer skin tap technique on hepatitis B and DTaP-IPV-Hib vaccinations-related pain. This study will be investigated the effects of mechanical vibration and Helfer skin tap technique methods on procedural pain, crying time and duration of the procedure during intramuscular vaccinations 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
- 3
- Model description
- Participants will be assigned to experimental and control groups using block randomization method. Body weight and sex variables will be used for block randomization.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive routine vaccinations. |
| Mechanical vibration | Experimental | Device: Mechanical vibrationMechanical vibration will be used during routine vaccination of infants in this group. |
| Helfer skin tap technique | Experimental | Behavioral: Helfer skin tap technique (HSTT)Helfer skin tap technique will be used during routine vaccinations of infants in this group. |
Who may qualify
- Ages
- 6 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- healthy term infants
- born at 38-42 weeks gestational week,
- birth weight 2500-4400 g,
- in stable health,
- able to carry out vital activities without support,
Key exclusion criteria (6 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 |
|---|---|---|
| Mechanical vibrationThe vibration device will be placed on the procedure site (on the vastus lateralis muscle) on the left extremity and fixed through a long gauze. The vibration device will be operated for 30 seconds with reference to previous studies, then the nurse will administer routine intramuscular Hepatitis B vaccine. A gap of approximately 1-2 cm will be left between the device and the injection site. After the vaccination procedure is completed, the vibration will be terminated. The same procedure was repeated for DTaP-IPV-Hib vaccine administered to the the right extremity. The baby will be swaddled and placed in the mother's lap. | Device | Mechanical vibration |
| Helfer skin tap technique (HSTT)In this group, HSTT consisting of 4-stage strokes will be applied to the vaccination site. The nurse will make approximately 10 strokes for 5 seconds with the palmar side of the fingers of the dominant hand to the injection site to relax the muscles (Stage 1). The nurse will give a V-shaped position to the thumb and index finger of the non-dominant hand and give 3 strokes to the injection site with the palmar side of the fingers (Stage 2). The skin entry site of the needle will remain inside the V-shape. Simultaneously with the 3rd stroke, the nurse will insert the needle into the muscle at a 90 degree angle. The nurse will inject the vaccine into the muscle while continuing to tap the skin with the palmar side of the fingers of the non-dominant hand (Stage 3). The nurse will make 3 strokes on the skin with the palmar side of the fingers of the non-dominant hand at the injection site, simultaneously with the 3rd stroke, the needle will be removed from the baby's skin (Stage 4). | Behavioural | Helfer skin tap technique |
Primary outcome
Procedural pain score: FLACC 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 FLACC scale includes the evaluation of five basic behavioural categories. The validity and reliability of the Turkish version of the Pain Diagnostic Scale (FLACC) was conducted. Each of facial expressions, leg movements, activity, crying, and consolability parameters also consists of three sub-items. The items are scored as 0, 1, and 2 point(s) respectively, with total score ranging between 0 to 10 point(s). The "0" point shows that there is no pain, 1-3 points refer to mild pain, 4-6 points refer to moderate pain, and 7-10 points refer to severe pain in infants.
2 secondary outcomes
Crying time during the procedure
Time frame: Through painful procedure completion, an average of 4 minutes
Length of 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 13 Jan 2025.
- 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 36115789Guven SD, Cakirer Calbayram N. The effect of Helfer skin tap technique on hepatitis B vaccine intramuscular injection pain in neonates: A randomized controlled trial. Explore (NY). 2023 Mar-Apr;19(2):238-242. doi: 10.1016/j.explore.2022.09.001. Epub 2022 Sep 8.
- 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 Mechanical vibration and Helfer skin tap technique (HSTT) in people with Procedural Pain and Nursing Caries, 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 6 inclusion and 6 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 13 Jan 2025. 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: FLACC 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 NCT06454812, 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 13 Jan 2025.