Clinical trial NCT06454812: The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Infants During Vaccination
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Nursing Caries
Pain, Acute
Keywords: Healthy infant
Nonpharmacological pain management
Procedural pain
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedural pain score: FLACC Pain Scale
timeFrame: 1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 minutes
Secondary outcomes:
measure: Crying time during the procedure
timeFrame: Through painful procedure completion, an average of 4 minutes
measure: Length of procedure time
timeFrame: Through painful procedure completion, an average of 60 seconds
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadıköy
Study officials:
affiliation: Istanbul Medeniyet University
name: Aynur Aytekin Özdemir, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.