Effects of Yakson Method and Swaddling on Pain and Physiological Parameters

Istanbul University - Cerrahpasa48 enrolled

Overview

Type of Study: The study was planned to be conducted in a randomized controlled experimental design. Place and Time of the Research: Institutional permission will be obtained from the Balcalı Training and Research Hospital in Adana for the collection of research data. Researchers commit to start data collection after obtaining institutional permission. The data collection process will take 1 year after obtaining the institutional permission. 48 newborns who are suited the inclusion criteria will be included in the study. Participants will be assigned to 3 groups according to randomization: Swaddling, Yakson Method, and Control.

Total processing time and baby's crying time are calculated by watching video recordings. In order to find the total procedure time, starting from the puncture of the baby's heel, the time until the dry cotton is placed on the baby's heel after the blood collection process is completed is calculated. The heart rate and SpO2 are noted by the investigator during the heel lancing procedure. Pain assessment of infants is done by two independent neonatal nurses, apart from the researcher, by watching video recordings. The scores given by the two observers will be evaluated by making inter-observer harmony. Before the evaluation, the nurses will be trained about the scale and its evaluation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Pain During Heal Lancing

Eligibility

Sex: ALLMin age: 0 DaysMax age: 28 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion Criteria for Newborn: * Born at term (38-42 weeks) * Healthy newborn * Absence of congenital anomaly * No analgesic or sedative medication has been administered in the last 6 hours * Parent's consent for inclusion in the study in accordance with the consent form Inclusion Criteria for Mother: * Mother's willingness to participate in the study * The mother can be mobilized and not have a physical disability (so that she can appyl Yakson therapy for her baby) * Being communicative Exclusion Criteria: * Babies whose blood cannot be drawn on the first try

Outcomes

Primary Outcomes

Neonatal Infant Pain Scale (NIPS):

This scale was developed in 1993 by Lawrence et al. for premature and newborns. The scale measures the infant's response to pain behaviorally. The total score of the scale ranges from 0 to 7, and scores higher than 3 indicate the presence of pain.

Time frame: 1 year