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The Effect of Supportive Nursing Interventions of Mothers of Infants in Neonatal Intensive Care Unit

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU).
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological focused on measuring cortisol, mother, neonatal intensive care, neonate, stress, supportive intervention

Eligibility Criteria

28 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being aged between 20-40,
  • having no chronic physical and psychological problems, being literate,
  • no previously receiving training about the care of infants hospitalised in the NICU.

Exclusion Criteria:

  • Having a gestational age of <28 and >37 weeks,
  • Having a birth weight of 1500 grams less,

Sites / Locations

  • Dilek alemdar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

supportive interventions group

control group

Arm Description

Supportive and educational nursing interventions about reducing maternal stress levels in the experimental group included the following: the NICU was physically described to mothers on the first day they visited their infants, mothers were introduced to team members, and given information about how to obtain information about their baby, visiting hours and conditions.

Mothers did not have any other intervention applied by the researchers during routine operation while their infants were in the unit.

Outcomes

Primary Outcome Measures

Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)
This scale was developed by Miles, Funk and Carlson (1993) with the aim of determining the perceptions of parents about stressors due to the physical and psychosocial environment in the NICU. The scale uses a 5-point Likert score grading from 1 (not stressful) to 5 (excessively stressful).
Neonatal Infant Care Unit Parent Belief Scale (NICU PBS)
This scale developed by Melnyk et al. (2014) has three subdimensions (Parental Role Confidence, Parent-Baby Interaction, and Knowledge of the NICU) and includes a total of 18 items.
State-Trait Anxiety Scale (STAI TX-2)
The scale developed by Spielberger et al. in 1970 was adapted to Turkish with validity and reliability studies completed by Öner and Le Comte in 1983. The scale comprises 40 questions, with 20 questions about state and 20 questions about trait anxiety levels. In the research, 20 questions measuring trait anxiety were used. Expressions on the trait anxiety scale have choices of nearly never (1), sometimes (2), often (3), and nearly all the time (4). Items 21, 26, 27, 39, 33, 36 and 39 are inverse statements.
Saliva Cortisol Measurement
With the aim of determining cortisol levels in saliva, taking saliva samples with a kit is an easy and non-invasive method that does not cause stress (Kirschbaum & Hellhammer, 1994). Mothers were requested to avoid practices like eating-drinking and chewing gum for 30 minutes before the saliva collection procedure. Saliva samples were collected with special saliva test kits. Cotton from the kit is rotated within the mouth, cheeks and under the tongue for 1-2 minutes or chewed to complete the saliva collection procedure. Immediately after collecting saliva samples, they were centrifuged and stored at -20 degrees before transport to the laboratory. Saliva samples from mothers were taken from 08:00-10:00 in the morning.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2021
Last Updated
September 7, 2021
Sponsor
T.C. ORDU ÜNİVERSİTESİ
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1. Study Identification

Unique Protocol Identification Number
NCT04830150
Brief Title
The Effect of Supportive Nursing Interventions of Mothers of Infants in Neonatal Intensive Care Unit
Official Title
The Effect of Supportive Nursing Interventions on Reducing Stress Levels of Mothers of Infants in Neonatal Intensive Care Unit: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: This study was conducted to determine the effects of supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU). Backround: The inability to nurture the healthy baby dreamed of, disease and intensive care processes are situations causing a crisis for parents. The stress experienced by mothers may affect emotional status and the foundation of the mother-ınfant attachment. For this reason, mothers of infants hospitalized in the NICU need support to cope with the stressful events they experience. Design: This study was a prospective, pre-and post-test randomised controlled trial. Methods: The population of the research comprised mothers with neonates admitted to the NICU of a state hospital, abiding by the sample selection criteria and who accepted participation in the research. The research was completed with 85 mothers in two groups of 45 subjects and 40 controls selected at random. Data collection used the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU), NICU Parent Belief Scale (NICU:PBS), State-Trait Anxiety Inventory (STAI TX-2) and saliva cortisol analysis.
Detailed Description
This study was performed with the aim of determining the effect of supportive interventions on maternal stress levels among mothers with infants hospitalized in the NICU. This was a randomized pre- and post-test controlled trial was conducted to determined the effect of planned educational and supportive nursing interventions given to mothers with infants in the NICU on the stress, anxiety and beliefs of mothers in the NICU of Women and Pediatrics Training and Research Hospital. This study was conducted at a state hospital's NICU in the east part of Turkey. According to the criteria of the T.R. Ministry of Health, the unit in which the study was performed was a Level I NICU. The unit had 10 incubators and 10 nurses were employed in the NICU. The nurses in the NICU worked in groups of three, in two shifts, providing care and treatment of the newborns in the unit. This part of Turkey is geographically located in a rural area in the east. The mothers with infants in the NICU were informed by the physicians and nurses on certain days of the week about the hours at which they were allowed to visit their infants. Power analysis of the sample number used the G*Power (v. 3.1.9.2) program and was based on previous studies. According to Jacob Cohen's effect size coefficients, assuming large effect size in assessments between two independent groups (d=0.40), with α=0.05 and 1-β=0.95 (90% power), each group was required to contain at least 39 people. Considering data loss, each group included 50 mothers. As saliva samples were insufficient in 10 mothers in the experiment group and 5 mothers in the control group, this data was excluded from the study. The research was completed with 85 mothers, comprising 40 subjects and 45 controls chosen at random (Fig. 1). 2.3. Randomization: sequence generation, type, allocation concealment mechanism, and implementation Randomization was performed using a computer program. The participants were randomised and assigned by a researcher into two groups using the Integer Generator free software (www.random.org), which produces random numbers in configurable intervals: 40 in intervention group and 45 in control group. Data collection used the "Mother and Neonate Descriptive Information Form", "Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)", "NICU Parent Belief Scale (NICU PBS)", State-Trait Anxiety Inventory (STAI TX-2)" and "saliva cortisol analysis". Before the mothers first visits to their infants, the mother and neonate descriptive information form, PSS: NICU, STAI TX-2 and NICU Parent Belief scale were completed by the researcher during face-to-face interviews with the mother and first saliva samples were taken from mothers. Mothers in the group with supportive nursing interventions completed the PSS:NICU, NICU-Parent Belief Scale and STAI-TX-2 again and had the post-test saliva sample taken when their infants were discharged from the NICU. Supportive and educational nursing interventions about reducing maternal stress levels in the experimental group included the following: the NICU was physically described to mothers on the first day they visited their infants, mothers were introduced to team members, and given information about how to obtain information about their baby, visiting hours and conditions. Special tools and devices required for care like respiratory devices and monitors were described, and information was given about treatment of the neonate and general status. Mothers of neonates with appropriate clinical status were encouraged to touch their baby and hold their hand. Within the rules of the unit mothers were allowed to touch and hold their baby. Introduction to the NICU, informing about the baby and contact between mother and baby was completed within 30-45 minutes duration. As a guide to training, a 35-page "Care of your Baby in the Neonatal Intensive Care Unit" training booklet prepared by the researcher based on stress among families in the intensive care unit was given to mothers and included topics like the NICU environment, features of neonates born prematurely and at term, care, feeding, diseases, treatment methods, stress in the NICU, breastfeeding, preparation for discharge and baby care at home. After the information session on the first visiting day for mothers and babies, seven interactive trainings were held each lasting nearly 90 minutes during the neonate's admission to hospital. During interactive training, power point presentations prepared by the researcher were presented on a large screen in the education salon in the hospital and arranged in two 45-minute sessions allowing mothers to share their experiences, excitement, sadness and worries. Planned nursing interventions were standardised for each mother with a check-list. Mothers were given information training about the NICU environment, features of babies born prematurely and at term, care, feeding, disease, treatment methods, stress in the NICU, breastfeeding, preparation for discharge and baby care at home. The relevant topics were chosen after relevant literature search by the researcher (Konukbay & Arslan, 2011; Lonio et al. 2016; Uludağ & Ünlüoğlu, 2012) and the second author's personal experience with parents of infants in the NICU. In the second session, the researchers gave training about positive thinking, healthy lifestyle, knowing yourself, stress management and relaxation techniques developed in the context of the literature within the scope of supportive nursing interventions for mothers (Nasiri et al., 2018; Nasiri et al., 2018). Mothers were taught the simple but powerful relaxation technique which is easy and can be performed nearly everywhere of deep breathing (diaphragmatic respiration). Each session began with this exercise and they were encouraged to perform it throughout the day. During mothers first visits to their infants, mothers in this group had the mother and neonate descriptive information form, PSS: NICU, STAI TX-2 and NICU Parent Belief scale applied and first saliva samples were taken from mothers. Mothers did not have any other intervention applied by the researchers during routine operation while their infants were in the unit. When their infants were discharged from the NICU, mothers completed the PSS:NICU, NICU-Parent Belief Scale and STAI-TX-2 again and had the post-test saliva sample taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
cortisol, mother, neonatal intensive care, neonate, stress, supportive intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was a prospective, pre-and post-test randomised controlled trial.
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supportive interventions group
Arm Type
Experimental
Arm Description
Supportive and educational nursing interventions about reducing maternal stress levels in the experimental group included the following: the NICU was physically described to mothers on the first day they visited their infants, mothers were introduced to team members, and given information about how to obtain information about their baby, visiting hours and conditions.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Mothers did not have any other intervention applied by the researchers during routine operation while their infants were in the unit.
Intervention Type
Behavioral
Intervention Name(s)
Supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU).
Intervention Description
This study was conducted to determine the effects of supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU).
Primary Outcome Measure Information:
Title
Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)
Description
This scale was developed by Miles, Funk and Carlson (1993) with the aim of determining the perceptions of parents about stressors due to the physical and psychosocial environment in the NICU. The scale uses a 5-point Likert score grading from 1 (not stressful) to 5 (excessively stressful).
Time Frame
Before the mothers first visits to their infants (the third day).
Title
Neonatal Infant Care Unit Parent Belief Scale (NICU PBS)
Description
This scale developed by Melnyk et al. (2014) has three subdimensions (Parental Role Confidence, Parent-Baby Interaction, and Knowledge of the NICU) and includes a total of 18 items.
Time Frame
Before the mothers first visits to their infants (the third day).
Title
State-Trait Anxiety Scale (STAI TX-2)
Description
The scale developed by Spielberger et al. in 1970 was adapted to Turkish with validity and reliability studies completed by Öner and Le Comte in 1983. The scale comprises 40 questions, with 20 questions about state and 20 questions about trait anxiety levels. In the research, 20 questions measuring trait anxiety were used. Expressions on the trait anxiety scale have choices of nearly never (1), sometimes (2), often (3), and nearly all the time (4). Items 21, 26, 27, 39, 33, 36 and 39 are inverse statements.
Time Frame
Before the mothers first visits to their infants (the third day).
Title
Saliva Cortisol Measurement
Description
With the aim of determining cortisol levels in saliva, taking saliva samples with a kit is an easy and non-invasive method that does not cause stress (Kirschbaum & Hellhammer, 1994). Mothers were requested to avoid practices like eating-drinking and chewing gum for 30 minutes before the saliva collection procedure. Saliva samples were collected with special saliva test kits. Cotton from the kit is rotated within the mouth, cheeks and under the tongue for 1-2 minutes or chewed to complete the saliva collection procedure. Immediately after collecting saliva samples, they were centrifuged and stored at -20 degrees before transport to the laboratory. Saliva samples from mothers were taken from 08:00-10:00 in the morning.
Time Frame
Before the mothers first visits to their infants (the third day).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being aged between 20-40, having no chronic physical and psychological problems, being literate, no previously receiving training about the care of infants hospitalised in the NICU. Exclusion Criteria: Having a gestational age of <28 and >37 weeks, Having a birth weight of 1500 grams less,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Küçük Alemdar, Phd
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Study Director
Facility Information:
Facility Name
Dilek alemdar
City
Ordu
ZIP/Postal Code
52000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study was a prospective, pre-and post-test randomised controlled trial.
Citations:
PubMed Identifier
34555952
Citation
Yilmaz G, Kucuk Alemdar D. The Effect of Supportive Nursing Interventions on Reducing Stress Levels of Mothers of Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Trial. Clin Nurs Res. 2022 Jun;31(5):941-951. doi: 10.1177/10547738211047359. Epub 2021 Sep 24.
Results Reference
derived

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The Effect of Supportive Nursing Interventions of Mothers of Infants in Neonatal Intensive Care Unit

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