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Recruiting NCT05700552

Skin-to-skin Contact for Newborn First Injection Pain

Conditions: Pain

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 60
Sponsor: Kocaeli University

Location: Turkey

Summary

This study is carried out to examine the effect of skin-to-skin contact on the pain and stress level of the first intramuscular injection after elective cesarean section. The universe of the research will be women who have had elective cesarean section at Darıca Farabi Training and Research Hospital. The sample size of the study was calculated using the G*Power 3.1.9.2 program. The minimum number of individuals to be included in the sample of this study was calculated by taking G*Power 3.1.9.2, effect size: 1.42 α= 0.05, power: 0.95, and the sample size was determined as at least 14 mothers and their newborns in each group (skin skin-to-skin contact group: 14, non-skin-to-skin contact group: 14). In the study, possible data losses will be foreseen and 60 newborns and mothers, 30 of which will be in the intervention group and 30 in the control group, will be taken. The group of the participants included in the research will be divided into two groups by determining the random number generation program on the website called "Random List". (https://www.randomlists.com/). After obtaining the necessary ethics committee and institutional permissions for the implementation of the study, participants who had a cesarean delivery and who met the inclusion criteria of the study will be interviewed by going to the institution. Those who accept and want to participate in the research will have the Voluntary Consent Form read and their signatures will be taken. Term newborns meeting the criteria will be divided into intervention and control groups. The data will be collected by the researcher working in the delivery room of the hospital through face-to-face interviews. In the study, newborns who received skin-to-skin contact during the first IM injection will be included in the intervention group, and newborns who have been routinely injected intramuscularly in the delivery room will be included in the control group. In the study, all the steps of the intervention and control group newborns before and after the application will be carried out by the researcher.

Eligibility Criteria

Inclusion Criteria:Able to speak and understand Turkish,Conceiving naturally,At the end of the gestational week (37-42 weeks),Will have an elective cesarean delivery,In cesarean delivery, only spinal anesthesia is applied,No hearing problem,Women willing to participate in the research,Not having a risky pregnancy,Single fetus,A first-minute APGAR score (scoring system that shows the newborn's health status) is 7 and above (healthy newborn that does not require any intervention),No congenital anomaly,Does not require observation in neonatal intensive care,Newborns with a birth weight between 2500 - 4000 g.Exclusion Criteria:Those who do not have sufficient mental health to fill out the questionnaire,Newborns who need oxygen support or dead newbornsExposed to any painful stimulus (Venous-capillary sample),Those who may refuse to receive the hepatitis B vaccine, vitamin K or any injectionsWomen and newborns with any maternal and/or neonatal risk conditions in the early postpartum period will not be included in the study.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05700552). StuddyBuddy aggregates publicly available trial information.