Skin-to-skin Contact for Newborn First Injection Pain
Condition: Pain
Study type: Interventional

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.
    

Detailed description: 
      Aim: This study will be carried out to examine the effect of skin-to-skin contact after
      elective cesarean section on the pain and stress level of the first intramuscular injection
      given to the newborn.

      Research hypothesis:

      Hypothesis (H0): Skin-to-skin contact has no effect on the level of pain and stress felt
      during the first intramuscular injection in newborns after elective cesarean section.

      Hypothesis (H1): Skin-to-skin contact has an effect on the level of pain and stress felt
      during the first intramuscular injection in newborns after elective cesarean section.

      Type of Study: This study was designed as a randomized controlled experimental study.

      Data will be collected by the researcher from the Delivery Room and Operating Room units.
      Before the skin-to-skin contact procedure after elective cesarean section, the mother will be
      informed about the application and the purpose of the research will be explained. 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. In determining the selection process, the random number
      generation program will be divided into two groups by using the website called "Random List".
      (https://www.randomlists.com/). Thus, each participant's group and group number will be
      determined and recorded. 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.

      Research data will be collected by using the Pregnancy Information Form, Neonatal Follow-up
      Form and Neonatal Pain and Stress Assessment Scale (ALPS-Neo) created by the researchers
      within the framework of the relevant literature.

      Pregnant Information Form: It was prepared by the researcher within the framework of the
      literature. The form consists of a total of 19 questions, 7 open-ended and 12 closed-ended,
      questioning women's socio-demographic knowledge of obstetrics.

      Neonatal Follow-up Form: Newborn's vital sign measurements (body temperature, blood pressure,
      heart rate, oxygen saturation, respiratory rate), orocephalic response (head orientation,
      sucking reflex, oral movement, facial expression) and first breastfeeding initiation,
      including newborn introductory features. It contains 26 questions consisting of a table in
      which time and duration measurements will be recorded.

      Neonatal pain and stress rating scale (ALPS-Neo): Lundqvist et al. (2014) to evaluate pain
      and stress in premature and term newborns. The Cronbach's alpha coefficient of the scale was
      reported as 0.95. 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.

      Applicable to the Intervention Group 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. Preheated
      blankets will be placed on the chest area of the mother in the same way and her temperature
      will be measured with a thermometer before skin-to-skin contact. Those with low body
      temperature will be excluded. 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 due to the implementation of hospital
      procedures, skin-to-skin contact will be applied for about 3 minutes and the first injection
      will be performed. After the injection, vital signs of the newborn (body temperature, blood
      pressure, peak heart rate, oxygen saturation, respiratory rate) will be measured, oxygen
      demand, orocephalic responses (head orientation, sucking reflex, oral movement, facial
      expression) will be observed, ALPS-Neo Newborn Pain and the scores from the Stress Rating
      Scale will be evaluated and recorded. Further examinations of the newborn will take place in
      the delivery room. When the mother is transferred from the operating room to the gynecology
      service, her newborn will be taken. And the time and duration of first breastfeeding
      initiation will be evaluated and recorded.

      Applicable to the Control Group 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. After the injection, vital signs of the newborn (body temperature,
      blood pressure, peak heart rate, oxygen saturation, respiratory rate) will be measured,
      oxygen demand, orocephalic responses (head orientation, sucking reflex, oral movement, facial
      expression) will be observed, ALPS-Neo Newborn Pain and the scores from the Stress Rating
      Scale will be evaluated and recorded. After the newborn's procedures and examination, he is
      transferred to his room in the gynecology service. On average, these processes and transfer
      time take 30-45 minutes. As a routine practice of the hospital, due to the transfer process
      and stabilization of the patient, the first skin contact of the mother and the baby and the
      time to start breastfeeding take place approximately 1-2 hours later. This process will be
      observed and the first breastfeeding time will be recorded by evaluating the skin-to-skin
      contact time and breastfeeding time.

      Statistical and Analytical Methods:

      Statistical analysis will be performed using the IBM SPSS Statistic 22.0 (IBM Corp. , Armonk
      , NY, USA) program. Descriptive statistical methods (number, percentage, mean, standard
      deviation) will be used in the evaluation of sociodemographic data. Parametric tests
      (chi-square, T test, etc.) and non-paramedic tests (Mann-Whitney U Test, Kruskal Wallis,
      etc.) will be used in the comparison of categorical variables when it is seen that the data
      are suitable for normal distribution) will be used when it is not suitable for a normal
      distribution. P significance level will be accepted as 0.05.
    

Intervention name(s): skin to skin contact
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): kangaroo care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: skin to skin contact; Newborn; stress; cesarean section