- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401043
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
Investigators
- 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)
September 20, 2019
Primary Completion (Actual)
September 20, 2019
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
December 3, 2025
First Submitted That Met QC Criteria
February 6, 2026
First Posted (Actual)
February 10, 2026
Study Record Updates
Last Update Posted (Actual)
February 10, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID 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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