<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04478162</url>
  </required_header>
  <id_info>
    <org_study_id>16214662/050.01.04/14</org_study_id>
    <nct_id>NCT04478162</nct_id>
  </id_info>
  <brief_title>The Effect of Family Integrated Care on Preparing Parents With Premature Infants Hospitalized in the Neonatal Intensive Care Unit for Discharge</brief_title>
  <official_title>Investigation of the Effect of Family Integrated Care Method on Preparedness for Discharge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sakarya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sakarya University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physiological and structural features of premature infants differ from mature newborns.&#xD;
      Families worry about touching their very sensitive and fragile babies, which are quite&#xD;
      different from their expectations, and they seriously concern about how they will take care&#xD;
      of their babies who are cared for by the specialist staff at the hospital when they are&#xD;
      discharged to home. Different approaches and models are applied in the Neonatal Intensive&#xD;
      Care Units (NICU) to prepare families, especially mothers, for the discharge process and to&#xD;
      overcome these fears of the parents. However, most of the time, investigators observe in both&#xD;
      researches and units that these approaches are not efficient. In this study, which&#xD;
      investigators started with the questions as &quot;What can investigators do better in this issue?&quot;&#xD;
      and &quot;How can investigators help families more in this process?&quot;, investigator have seen that&#xD;
      Family Integrated Care (FICare) model is applied in some clinics abroad and successful&#xD;
      results have been obtained. However, investigators did not come across a study that applied&#xD;
      this model and examined the effect of it on parents on being ready for discharge. Since this&#xD;
      study will be a first in terms of both this aspect and the application of this model in our&#xD;
      country, in this unique study, investigators aim to draw attention to this approach in our&#xD;
      country, also contribute to keeping the premature babies healthy.&#xD;
&#xD;
      Research Hypotheses:&#xD;
&#xD;
      H0: Family Integrated Care Model is not an effective method for parents to be ready for&#xD;
      discharge.&#xD;
&#xD;
      H1: Family Integrated Care Model can be applied in NICU. H2: Family Integrated Care Model&#xD;
      positively affects parents' readiness for discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The Family Integrated Care (FICare) model is a modern approach that supports the&#xD;
      participation of parents (excluding ventilation, monitor adjustments, vascular fluid and drug&#xD;
      administration) developed in collaboration between parents and healthcare professionals,&#xD;
      which is carried out gradually in the NICU (1). Parents are informed about the general&#xD;
      development of the baby, brain and sensory development, motor and behavior development, care&#xD;
      of the premature. In addition, parents are informed about what they can do about general body&#xD;
      cleaning and care, especially in touch, attachment, skin-to-skin contact, breastfeeding and&#xD;
      increased breast milk and diaper change (2).FICare; It is a care model with a 25% increase in&#xD;
      the weight gain of premature babies, a 80% increase in breastfeeding rate, a 25% decrease in&#xD;
      parental stress, a significant decrease in critical incident reports such as hospital&#xD;
      infection and sudden infant death (3). The care that these babies receive in their first&#xD;
      hours, days, weeks and months is vital to determine their future health and long-term&#xD;
      outcomes. Evidence suggests that if parents are supported and encouraged to take care of&#xD;
      their babies while in hospital, this will have better outcomes for both the baby and their&#xD;
      family. FICare support not only reduces the length of hospital stay of parents, but also&#xD;
      reduces the rate of re-hospitalization, and strengthens the bond between parents and babies.&#xD;
      It helps parents feel safer when taking care of their babies, both in the hospital and at&#xD;
      home (4).&#xD;
&#xD;
      A standard care model for discharge preparation is not applied to parents who have a&#xD;
      premature baby in their NICU. Institutions make the decision to discharge with the opinions&#xD;
      of the doctor and nurse working in the unit. With the FICare model, it is thought that&#xD;
      parents will be prepared for discharge, bonding between parents and babies, fulfilling their&#xD;
      parental roles, supporting babies' breastfeeding, reducing hospital stay, enhancing&#xD;
      parental-employee communication, and increasing the quality of care services..&#xD;
&#xD;
      Method: This research is a randomized controlled experimental study. The data of the research&#xD;
      will be carried out between 01.08.2020-01.05.2021 with the parents of the premature babies in&#xD;
      accordance with the inclusion criteria in the Neonatal Intensive Care Unit of the Ministry of&#xD;
      Health University Education and Research Hospital. The sample of the study was calculated in&#xD;
      accordance with the intervention group selection criteria and by performing power analysis.&#xD;
      Power analysis was performed using G * Power (v3.1.7) program in order to determine sample&#xD;
      size. The effect range value was taken as 0.70 as the method used in cases where it is&#xD;
      unknown how many units difference is significant between the groups. In cases where Type 1&#xD;
      error probability (α) was 0.05 (at a confidence level of 95%), at a power level of 80% and&#xD;
      the effect range was 0.70, the study was planned with a total of 68 mothers, including 34&#xD;
      mothers women for each group. It will be ensured that the mothers to be assigned to the study&#xD;
      and control groups show similarity in terms of two factors (age, education level). People&#xD;
      will be assigned to groups with simple random sampling. The sample of the study will randomly&#xD;
      allocated into two groups: the FICare model will be applied to the intervention group, and&#xD;
      the other group, which was the control group, will be followed in the routine maintenance of&#xD;
      the service. Since the Family Integrated Care model will be given by researchers and baby&#xD;
      nurses trained in this subject, single blind (researchers are not blind) randomization will&#xD;
      be provided. The statistician was also blinded for the data analysis purpose. In the data&#xD;
      collection tools, investigators would use the &quot;Parental Identification Information Form&quot;&#xD;
      containing the sociodemographic characteristics of the family, the &quot;Newborn Identification&#xD;
      Information Form containing the characteristic features of the babies&quot; and the&#xD;
      readiness-ready scales prepared for mother and father, with validity and reliability studies.&#xD;
&#xD;
      FICare trainings will be given to the parents in the study group, and the parents will&#xD;
      experience their care (sub-care, skin care, bath etc.) applications on the model and then on&#xD;
      their babies.&#xD;
&#xD;
      There will be no intervention to the control group and the routine care and discharge process&#xD;
      of the clinic will be applied. The questionnaire will be applied to both groups in the first&#xD;
      24 hours of the baby's hospitalization, and the same questionnaire will be applied 24 hours&#xD;
      before the discharge plan. The results of the two surveys will be compared.&#xD;
&#xD;
      Statistical Analysis in Data Evaluation will be done using Statistical Package for the Social&#xD;
      Sciences (SPSS) software. For normality, the Kolmogorov-Smirnov (K-S) test will be used. In&#xD;
      order to determine whether there are differences in dependent variables according to&#xD;
      independent variables, independent group t-test will be used if the distribution is normal,&#xD;
      and if the distribution is not in normal percentages, Mann Whitney-U test will be used.&#xD;
      Results will be evaluated at 95% confidence interval and significance at p &lt;0.05 level&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">August 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The randomization will be done through the program with the Uniform Resource Locator (URL) address httpp://www.randomizer.org and it is planned to work with 1 month intervention and 1 month control group to prevent the groups from being affected by each other.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Family Integrated Care model and evaluation of routine care practicesevaluation) will increase the readiness of parents.</measure>
    <time_frame>up to nine months</time_frame>
    <description>With the questionnaire to be used separately for mothers (Preparedness for Discharge Scale of the Mother with a Premature Baby in the Neonatal Intensive Care Unit) and fathers (Preparedness for Discharge Scale of the Father with a Premature Baby in the Neonatal Intensive Care Unit) with premature babies, their readiness for discharge will be measured. A minimum score of 22, a maximum of 154 points are obtained from the form applied to mothers, a minimum of 20 and a maximum of 140 points from the form applied to fathers. High scores indicate that parents are ready for discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Premature infants weight (kg)</measure>
    <time_frame>up to nine months</time_frame>
    <description>Body weight will be measured every day from the day the baby is admitted to NICU until the day she is discharged.Body weight will be measured every day from the day the baby is admitted to NICU until the day she is discharged.&#xD;
Measurements obtained by the percentile curve are evaluated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Neonatal Intensive Care Unit</condition>
  <condition>Parents</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Newborn to be premature (28-34 Gestation Weeks), The baby is admitted to the neonatal intensive care unit,sleeps for at least 7 days, Any screened newborn gastrointestinal, neurological, and Genetic the absence of disease, Mother and father being open to communication and cooperation, Mother and father volunteering to participate in the research, Being a literate mother and father, The mother has primiparous and first maternity experience, Having the first parenting experience in your father, Your mom and dad being 19 and over, Participation of parents in the initiative group in training and practices for the FICare model, Participation in routine care in parents in the NICU to the parents in the control group, Baby nurses in charge of a 4-hour training on the Family Integrated Care model, Mothers and fathers in the venture group stay at least 6-8 hours a day in hospital, Mothers and fathers in the intervention group to perform at least 3 treatments a day with a nurse,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Groups</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Babies in the control group will be monitored in routine service care. There will be no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.</intervention_name>
    <description>At least 1 week of FICare training for parents At least 4 hours of training on FICare for health professionals Trainings will be held between 13:30 and 15:30 in a training room with heat, light and seating arrangement (for parents who are not able to participate in the training during the week, trainings will be held at the appropriate time interval on the weekend .) Premature baby dummy on oral care, eye care, nose care, ear care, skin care, bath, attired in clothes,/removal, safe sleeping baby, safe transport, kangaroo care (physical contact), non-invasive drug application will be shown and the parents also will be asked to implement,</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborn to be premature (between 28 and 34 weeks of gestation)&#xD;
&#xD;
          -  The baby is admitted to the neonatal intensive care unit and sleeps for at least 7&#xD;
             days&#xD;
&#xD;
          -  The absence of congenital anomaly in the newborn (craniofacial anomaly such as cleft&#xD;
             palate, cleft lip, paralysis of facial muscles)&#xD;
&#xD;
          -  Any screened newborn gastrointestinal, neurological, and Genetic the absence of&#xD;
             disease&#xD;
&#xD;
          -  The absence of congenital heart disease requiring surgical treatment in newborns&#xD;
&#xD;
          -  The mother and father do not have a diagnosed psychiatric illness&#xD;
&#xD;
          -  Mother and father being open to communication and cooperation&#xD;
&#xD;
          -  Mother and father volunteering to participate in the research&#xD;
&#xD;
          -  Being a literate mother and father&#xD;
&#xD;
          -  The mother has primiparous and first maternity experience,&#xD;
&#xD;
          -  Having the first parenting experience in participant father&#xD;
&#xD;
          -  Participant mom and dad being 19 and over&#xD;
&#xD;
          -  Participation of parents in the initiative group in training and practices for the&#xD;
             FICare model&#xD;
&#xD;
          -  Participation in routine care in parents in the NICU to the parents in the control&#xD;
             group&#xD;
&#xD;
          -  Baby nurses in charge of a 4-hour training on the Family Integrated Care model&#xD;
&#xD;
          -  Mothers and fathers in the venture group stay at least 6-8 hours a day in hospital&#xD;
&#xD;
          -  Mothers and fathers in the intervention group to perform at least 3 treatments a day&#xD;
             with a nurse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  One of the parents does not want to join&#xD;
&#xD;
          -  Congenital anomaly of premature baby&#xD;
&#xD;
          -  Premature baby undergoing surgical intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Parents with premature babies at NICU</gender_description>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nursan ÇINAR, Proffesor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sakarya University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sakarya Education and Training Hospital</name>
      <address>
        <city>Sakarya</city>
        <state>Adapazarı</state>
        <zip>54050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/31502862/</url>
    <description>httpp</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/31502862/</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>May 13, 2023</last_update_submitted>
  <last_update_submitted_qc>May 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sakarya University</investigator_affiliation>
    <investigator_full_name>öznur tiryaki</investigator_full_name>
    <investigator_title>Nursing</investigator_title>
  </responsible_party>
  <keyword>premature</keyword>
  <keyword>Family Integrated Care</keyword>
  <keyword>discharge</keyword>
  <keyword>readiness</keyword>
  <keyword>parents</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Planning of the study, literature review, development of data collection tools, preparation of training slides and videos, provision of materials to be used in the study (2 months)&#xD;
Application of Family Integrated Care model, Collection of Data (8 months)&#xD;
Statistical analysis and evaluation of results (1 months)&#xD;
Writing the research report (1 months)</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04478162
org study id: 16214662/050.01.04/14
nct id: NCT04478162
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Physiological and structural features of premature infants differ from mature newborns.
      Families worry about touching their very sensitive and fragile babies, which are quite
      different from their expectations, and they seriously concern about how they will take care
      of their babies who are cared for by the specialist staff at the hospital when they are
      discharged to home. Different approaches and models are applied in the Neonatal Intensive
      Care Units (NICU) to prepare families, especially mothers, for the discharge process and to
      overcome these fears of the parents. However, most of the time, investigators observe in both
      researches and units that these approaches are not efficient. In this study, which
      investigators started with the questions as "What can investigators do better in this issue?"
      and "How can investigators help families more in this process?", investigator have seen that
      Family Integrated Care (FICare) model is applied in some clinics abroad and successful
      results have been obtained. However, investigators did not come across a study that applied
      this model and examined the effect of it on parents on being ready for discharge. Since this
      study will be a first in terms of both this aspect and the application of this model in our
      country, in this unique study, investigators aim to draw attention to this approach in our
      country, also contribute to keeping the premature babies healthy.

      Research Hypotheses:

      H0: Family Integrated Care Model is not an effective method for parents to be ready for
      discharge.

      H1: Family Integrated Care Model can be applied in NICU. H2: Family Integrated Care Model
      positively affects parents' readiness for discharge.
Background: The Family Integrated Care (FICare) model is a modern approach that supports the
      participation of parents (excluding ventilation, monitor adjustments, vascular fluid and drug
      administration) developed in collaboration between parents and healthcare professionals,
      which is carried out gradually in the NICU (1). Parents are informed about the general
      development of the baby, brain and sensory development, motor and behavior development, care
      of the premature. In addition, parents are informed about what they can do about general body
      cleaning and care, especially in touch, attachment, skin-to-skin contact, breastfeeding and
      increased breast milk and diaper change (2).FICare; It is a care model with a 25% increase in
      the weight gain of premature babies, a 80% increase in breastfeeding rate, a 25% decrease in
      parental stress, a significant decrease in critical incident reports such as hospital
      infection and sudden infant death (3). The care that these babies receive in their first
      hours, days, weeks and months is vital to determine their future health and long-term
      outcomes. Evidence suggests that if parents are supported and encouraged to take care of
      their babies while in hospital, this will have better outcomes for both the baby and their
      family. FICare support not only reduces the length of hospital stay of parents, but also
      reduces the rate of re-hospitalization, and strengthens the bond between parents and babies.
      It helps parents feel safer when taking care of their babies, both in the hospital and at
      home (4).

      A standard care model for discharge preparation is not applied to parents who have a
      premature baby in their NICU. Institutions make the decision to discharge with the opinions
      of the doctor and nurse working in the unit. With the FICare model, it is thought that
      parents will be prepared for discharge, bonding between parents and babies, fulfilling their
      parental roles, supporting babies' breastfeeding, reducing hospital stay, enhancing
      parental-employee communication, and increasing the quality of care services..

      Method: This research is a randomized controlled experimental study. The data of the research
      will be carried out between 01.08.2020-01.05.2021 with the parents of the premature babies in
      accordance with the inclusion criteria in the Neonatal Intensive Care Unit of the Ministry of
      Health University Education and Research Hospital. The sample of the study was calculated in
      accordance with the intervention group selection criteria and by performing power analysis.
      Power analysis was performed using G * Power (v3.1.7) program in order to determine sample
      size. The effect range value was taken as 0.70 as the method used in cases where it is
      unknown how many units difference is significant between the groups. In cases where Type 1
      error probability (α) was 0.05 (at a confidence level of 95%), at a power level of 80% and
      the effect range was 0.70, the study was planned with a total of 68 mothers, including 34
      mothers women for each group. It will be ensured that the mothers to be assigned to the study
      and control groups show similarity in terms of two factors (age, education level). People
      will be assigned to groups with simple random sampling. The sample of the study will randomly
      allocated into two groups: the FICare model will be applied to the intervention group, and
      the other group, which was the control group, will be followed in the routine maintenance of
      the service. Since the Family Integrated Care model will be given by researchers and baby
      nurses trained in this subject, single blind (researchers are not blind) randomization will
      be provided. The statistician was also blinded for the data analysis purpose. In the data
      collection tools, investigators would use the "Parental Identification Information Form"
      containing the sociodemographic characteristics of the family, the "Newborn Identification
      Information Form containing the characteristic features of the babies" and the
      readiness-ready scales prepared for mother and father, with validity and reliability studies.

      FICare trainings will be given to the parents in the study group, and the parents will
      experience their care (sub-care, skin care, bath etc.) applications on the model and then on
      their babies.

      There will be no intervention to the control group and the routine care and discharge process
      of the clinic will be applied. The questionnaire will be applied to both groups in the first
      24 hours of the baby's hospitalization, and the same questionnaire will be applied 24 hours
      before the discharge plan. The results of the two surveys will be compared.

      Statistical Analysis in Data Evaluation will be done using Statistical Package for the Social
      Sciences (SPSS) software. For normality, the Kolmogorov-Smirnov (K-S) test will be used. In
      order to determine whether there are differences in dependent variables according to
      independent variables, independent group t-test will be used if the distribution is normal,
      and if the distribution is not in normal percentages, Mann Whitney-U test will be used.
      Results will be evaluated at 95% confidence interval and significance at p <0.05 level
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: The randomization will be done through the program with the Uniform Resource Locator (URL) address httpp://www.randomizer.org and it is planned to work with 1 month intervention and 1 month control group to prevent the groups from being affected by each other.
measure: Family Integrated Care model and evaluation of routine care practicesevaluation) will increase the readiness of parents.
time frame: up to nine months
description: With the questionnaire to be used separately for mothers (Preparedness for Discharge Scale of the Mother with a Premature Baby in the Neonatal Intensive Care Unit) and fathers (Preparedness for Discharge Scale of the Father with a Premature Baby in the Neonatal Intensive Care Unit) with premature babies, their readiness for discharge will be measured. A minimum score of 22, a maximum of 154 points are obtained from the form applied to mothers, a minimum of 20 and a maximum of 140 points from the form applied to fathers. High scores indicate that parents are ready for discharge.
measure: Premature infants weight (kg)
time frame: up to nine months
description: Body weight will be measured every day from the day the baby is admitted to NICU until the day she is discharged.Body weight will be measured every day from the day the baby is admitted to NICU until the day she is discharged.
Measurements obtained by the percentile curve are evaluated.
arm group label: Experimental
arm group type: Experimental
description: Newborn to be premature (28-34 Gestation Weeks), The baby is admitted to the neonatal intensive care unit,sleeps for at least 7 days, Any screened newborn gastrointestinal, neurological, and Genetic the absence of disease, Mother and father being open to communication and cooperation, Mother and father volunteering to participate in the research, Being a literate mother and father, The mother has primiparous and first maternity experience, Having the first parenting experience in your father, Your mom and dad being 19 and over, Participation of parents in the initiative group in training and practices for the FICare model, Participation in routine care in parents in the NICU to the parents in the control group, Baby nurses in charge of a 4-hour training on the Family Integrated Care model, Mothers and fathers in the venture group stay at least 6-8 hours a day in hospital, Mothers and fathers in the intervention group to perform at least 3 treatments a day with a nurse,
arm group label: Control Groups
arm group type: No Intervention
description: Babies in the control group will be monitored in routine service care. There will be no intervention
intervention type: Other
intervention name: Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.
description: At least 1 week of FICare training for parents At least 4 hours of training on FICare for health professionals Trainings will be held between 13:30 and 15:30 in a training room with heat, light and seating arrangement (for parents who are not able to participate in the training during the week, trainings will be held at the appropriate time interval on the weekend .) Premature baby dummy on oral care, eye care, nose care, ear care, skin care, bath, attired in clothes,/removal, safe sleeping baby, safe transport, kangaroo care (physical contact), non-invasive drug application will be shown and the parents also will be asked to implement,
arm group label: Experimental
criteria: 
gender: All
gender based: Yes
gender description: Parents with premature babies at NICU
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nursan ÇINAR, Proffesor
role: Principal Investigator
affiliation: Sakarya University
facility: 
country: Turkey
url: https://pubmed.ncbi.nlm.nih.gov/31502862/
description: httpp
url: https://pubmed.ncbi.nlm.nih.gov/31502862/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Sakarya University
investigator full name: öznur tiryaki
investigator title: Nursing
sharing ipd: No
ipd description: Planning of the study, literature review, development of data collection tools, preparation of training slides and videos, provision of materials to be used in the study (2 months)
Application of Family Integrated Care model, Collection of Data (8 months)
Statistical analysis and evaluation of results (1 months)
Writing the research report (1 months)