Procedural Pain, Pain, Acute, Nursing Caries
Conditions
Keywords
Healthy infant, Nonpharmacological pain management, Procedural pain
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.
Interventions
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.
DEVICEShotBlocker
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.
COMBINATION_PRODUCTCombined facilitated tucking and ShotBlocker
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.
Sponsors
Istanbul Medeniyet University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Using the block randomization technique, participants will be divided into 4 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B, C and D using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each baby is in just before the application (researcher blinding). Parents will know which group the baby is in within the scope of the research. By the nature of the sample group, babies are blind. Research data will be entered into the computer database by coding the group name as A, B, C and D, and statistical analysis will be performed using this coding (statistician blinding).
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
38 Weeks to 42 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Infant Pain Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Crying time during the procedure | Through painful procedure completion, an average of 4 minutes | Total crying time during the procedure is the time the newborn cries between 1 min before and 3 min after the painful procedure. |
| Procedure time | Through painful procedure completion, an average of 60 seconds | For vaccine administration, it is the time between when the needle is inserted into the skin and when it is removed from the skin. |
Countries
Turkey (Türkiye)
Outcome results
None listed