The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Infants During Vaccination

Pain, Acute Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454812
• Other study ID #: 20.09.2023/174
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2024
• Source: Istanbul Medeniyet University
• Contact: Aynur Aytekin Özdemir, PhD
• Phone: +902162804104
• Email: aynur.ozdemir[@]medeniyet.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to determine the effect of mechanical vibration and Helfer Skin Tap technique applied during intramuscular Hepatitis B vaccination on procedural pain level, crying time and procedure time in healthy infants.

Description:

Hepatitis B 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 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 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 vaccination-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 Hepatitis B vaccination in healthy term infants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 7 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Nursing Caries
• Pain, Acute
• Pain, Procedural
• Procedural Pain

Intervention

Device:
• Mechanical vibration
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 baby will be swaddled and placed in the mother's lap.

Behavioral:
• 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)

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul	Kadiköy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Baba 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. — View Citation

Guven 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. — View Citation

McGinnis 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 minutes
Secondary	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.	Through painful procedure completion, an average of 4 minutes
Secondary	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.	Through painful procedure completion, an average of 60 seconds