Mothers Anxiety About Preterm Infants Care

February 6, 2026 updated by: Nurcan Akgül Gündoğdu

Effects of Solution-Focused Approach on Mothers Anxiety About Preterm Infants Care

It has been reported that mothers of preterm infants who experience anxiety face challenges in participating in infant care. However, the effect of solution-focused approach on reducing the anxiety of mothers of premature infants is unknown. This study was conducted to assess the effects of Solution-Focused Approach on the anxiety levels of mothers who are anxious about preterm infants care. A randomized controlled trial design. The present study was carried out in the Neonatal Intensive Care Units of three hospitals in a city center. In the study, the sample group was determined as 40 mothers, 20 of whom were interventions and 20 were control. In this study, eight 30-40minute solution-focused interviews were held with the participants in the intervention group subjected to the Solution Focused Approach. Of the mothers in the intervention group, 5% had triplet pregnancy, 75% gave birth by cesarean section, 80% had health problems during pregnancy and 95% did not receive training on infant care during pregnancy. The differences in scale scores obtained during follow-ups were greater in the intervention group than in the control group. It was determined that the intervention undergone by the mothers of the preterm infants in the intervention group decreased the mothers' anxiety levels about infant care and increased their solution-focused coping skills. Following the intervention, moms in the intervention group showed improvement in all of their self-perception skills about their care needs. The Solution-Focused Approach decreased state-trait anxiety levels of mothers who were anxious about preterm infant care, and improved their solution-focused coping skills. The Individual Solution-Focused Approach decreased state and trait anxiety levels of primiparous mothers who were anxious about preterm infant care, and improved their solution-focused coping skills. Nurses' application of this approach can reduce the anxiety levels of mothers who are worried about preterm infant care. It can contribute to mothers to develop a solution-focused perspective.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Sivas
      • Sivas, Sivas, Turkey (Türkiye), 58140
        • Sivas Cumhuriyet University Research and Training Hospital - Neonatal Intensive Care Unit (NICU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primiparous mothers
  • Having a preterm infant hospitalized in the NICU
  • Being in the discharge or mother-infant harmony process
  • Scoring ≥20 on at least one anxiety inventory
  • Ability to communicate in Turkish
  • Voluntary participation and written informed consent

Exclusion Criteria:

  • Having a serious medical or psychiatric condition preventing participation
  • Mother reporting she cannot continue the interviews
  • Mother being out of the province during the intervention dates

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Solution-Focused Approach (SFA)
Mothers in this arm received an Individual Solution-Focused Approach (SFA) intervention consisting of eight 30-45-minute sessions. Three sessions were conducted in the mother-infant harmony room during the NICU discharge process and five sessions were conducted at home during scheduled home visits. SFA techniques included goal setting, identifying exceptions, miracle questions, scaling, reframing, and letter writing. The intervention aimed to reduce maternal anxiety related to caring for a preterm infant and to improve solution-focused thinking skills.
Behavioral: Solution-Focused Approach (SFA)
The intervention consisted of eight individual Solution-Focused Approach (SFA) sessions lasting 30-45 minutes each. Three sessions were provided in the NICU mother-infant harmony room during the discharge process and five sessions were conducted at home during planned home visits. Techniques included goal setting, identifying exceptions, miracle questions, scaling, reframing, and letter writing. The intervention aimed to reduce maternal anxiety related to caring for a preterm infant and to improve solution-focused thinking skills.
No Intervention: Standard Care Control
Mothers in this arm received routine NICU discharge education and standard postpartum care as provided by the hospitals. No additional psychological or behavioral intervention was given between the pre-test and follow-up assessments. After the study was completed, SFA sessions were offered to mothers in the control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
State Anxiety Score
Time Frame: At baseline; one week after completion of the intervention; 2-month after completion of the intervention
Change in mothers' state anxiety levels measured using the State Anxiety Inventory (20-80 points; higher scores indicate greater anxiety). The scale was administered at baseline; one week after completion of the intervention; 2-month after completion of the intervention.
At baseline; one week after completion of the intervention; 2-month after completion of the intervention
Trait Anxiety Score
Time Frame: At baseline; one week after completion of the intervention; 2-month after completion of the intervention
Change in mothers' trait anxiety levels measured with the Trait Anxiety Inventory (20-80 points). Higher scores indicate higher trait anxiety. Measurements were taken at baseline; one week after completion of the intervention; 2-month after completion of the intervention.
At baseline; one week after completion of the intervention; 2-month after completion of the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Solution-Focused Thinking Skills Score
Time Frame: At baseline; one week after completion of the intervention; 2-month after completion of the intervention
Change in mothers' solution-focused thinking skills as measured by the Solution-Focused Inventory (12-72 points; higher scores indicate stronger solution-focused thinking). Scale administered at baseline; one week after completion of the intervention; 2-month after completion of the intervention.
At baseline; one week after completion of the intervention; 2-month after completion of the intervention
Home Care Needs Competence
Time Frame: At baseline; one week after completion of the intervention
Change in mothers' competencies in providing home care to their preterm infants, measured using the Home Care Needs Evaluation Form for Mothers of Preterm Infants. This form assesses maternal competence across multiple care domains. Higher scores indicate greater competence.
At baseline; one week after completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nurcan Akgül Gündoğdu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nurcan AKGUL GUNDOGDU, PhD, Assoc. Prof., Bandirma Onyedi Eylül University, Faculty of Health Sciences, Department of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BANÜ-SBF-NAG-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the dataset contains sensitive clinical and psychological information related to mothers and their preterm infants. Although all analyses were conducted using aggregated and de-identified data, the release of raw IPD is not planned due to ethical considerations, confidentiality requirements, and institutional data protection policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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