Skin-to-skin Contact for Newborn First Injection Pain

NCT05700552 | Completed

• 1 other identifier: sdilek3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

skin to skin contact; Newborn; stress; cesarean section

Outcome Measures

Primary Outcomes (2)

• ALPS-Neo Neonatal Pain and Stress Rating Scale

  The scale is a 0-1-2, 3-point Likert type scale consisting of 5 items in one dimension, including the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made by observation. A minimum of 0 and a maximum of 10 points are obtained from the scale. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress. The higher the stress and pain, the higher the score.

  This scala will be evaluated just before the intramuscular injection.

• ALPS-Neo Neonatal Pain and Stress Rating Scale

  The scale is a 0-1-2, 3-point Likert type scale consisting of 5 items in one dimension, including the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made by observation. A minimum of 0 and a maximum of 10 points are obtained from the scale. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress. The higher the stress and pain, the higher the score.

  This scala will be evaluated after administering the intramuscular injection.

Study Arms (2)

Intervention Group

EXPERIMENTAL

In the intervention group, after cesarean delivery in the operating room, maternal vital signs and the newborn's 1st and 5th minute Apgar Score will be evaluated. After the newborn baby is aspirated if necessary, dried with a green cover under the radiant warmer, tied the diaper, and put on a hat, the newborn with an Apgar Score ≥7 and vital signs stable will be wrapped in pre-warmed operating room covers. After providing a suitable environment, the newborn whose body temperature is stabilized will be placed in the prone position without any covering and clothing on the chest area of the mother, and the ALPS value will be applied for about 3 minutes due to the application of hospital procedures, the intramuscular injection will be applied and the ALPS score will be evaluated again after the injection.

Behavioral: skin to skin contact

Control group

NO INTERVENTION

The routine procedure of the institution where the study will be performed will be applied to the newborn baby after cesarean section in the control group. Within the scope of this procedure, after the baby is born, the umbilical cord is cut, mouth and nose aspiration is performed under the radiant heater in the operating room, they are dried, and the Apgar Score is evaluated at the 1st and 5th minutes by the midwife. The newborn is wrapped in pre-heated operating room covers, and after being shown to the mother, anthropometric measurements (height, body weight, head circumference) are taken and taken to the delivery room for the administration of vitamin K, hepatitis B vaccine, and the first examination of the baby. The first ALPS value will be recorded in the delivery room in the baby care area, the intramuscular injection will be applied and the ALPS score will be evaluated again after the injection.

Interventions

skin to skin contact BEHAVIORAL

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.

Also known as: kangaroo care

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Those who do not have sufficient mental health to fill out the questionnaire,
• Newborns who need oxygen support or dead newborns
• Exposed to any painful stimulus (Venous-capillary sample),
• Those who may refuse to receive the hepatitis B vaccine, vitamin K or any injections
• Women and newborns with any maternal and/or neonatal risk conditions in the early postpartum period will not be included in the study.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sena Dilek Aksoy, Ph.D

  Kocaeli University

  STUDY DIRECTOR

• Seda Yazici, M.Sc.

  Kocaeli Darica Farabi Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 26, 2023
• Study Start: January 6, 2023
• Primary Completion: May 31, 2023
• Study Completion: July 18, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)