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Skin-to-skin Contact for Newborn First Injection Pain

NCT05700552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-14

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

skin to skin contact

For skin-to-skin contact (TTT), the newborn is placed naked on the mother's bare chest in the prone (prone) position, the newborn's abdomen and chest are in contact with the mother's skin, and the newborn's head is turned to the side so that the airway remains open.

Sponsors & Collaborators

  • Kocaeli University

    lead OTHER

Principal Investigators

  • Sena Dilek Aksoy, Ph.D · Kocaeli University

  • Seda Yazici, M.Sc. · Kocaeli Darica Farabi Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2023-05-31
Completion
2023-07-18

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05700552 on ClinicalTrials.gov