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

NCT04830150 | Completed DMC

• 1 other identifier: 95531838-663.05
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Keywords

cortisol; mother; neonatal intensive care; neonate; stress; supportive intervention

Outcome Measures

Primary Outcomes (4)

• 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).

  Before the mothers first visits to their infants (the third day).

• 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.

  Before the mothers first visits to their infants (the third day).

• 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.

  Before the mothers first visits to their infants (the third day).

• 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.

  Before the mothers first visits to their infants (the third day).

Study Arms (2)

supportive interventions group

EXPERIMENTAL

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.

Behavioral: Supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU).

control group

NO INTERVENTION

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

Interventions

Supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU). BEHAVIORAL

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).

supportive interventions group

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Dilek alemdar

Ordu, 52000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34555952 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Intensive Care Units, Neonatal

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Intensive Care Units, Pediatric; Intensive Care Units; Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Dilek Küçük Alemdar, Phd

  Ordu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN

Model Details: This study was a prospective, pre-and post-test randomised controlled trial.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: March 20, 2018
• Primary Completion: August 20, 2019
• Study Completion: December 11, 2019
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)