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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Procedural Pain
- Sponsor
- Istanbul Medeniyet University
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Neonatal Infant Pain Scale
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
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.
Investigators
Aynur Aytekin Ozdemir
Professor
Istanbul Medeniyet University
Eligibility Criteria
Inclusion Criteria
- •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
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,
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Crying time during the procedure(Through painful procedure completion, an average of 4 minutes)
- Procedure time(Through painful procedure completion, an average of 60 seconds)