Maternal AnxietyNCT07401043
Mothers Anxiety About Preterm Infants Care
A study testing Solution-Focused Approach (SFA) in people with Maternal Anxiety, run by Nurcan Akgül Gündoğdu at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Maternal Anxiety
- What is being tested?
- Solution-Focused Approach (SFA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University Research and Training Hospital - Neonatal Intensive Care Unit (NICU)
Sivas, Sivas, 58140
About this study
Official title: 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.
- Conditions
- Maternal Anxiety
- Being tested
- Solution-Focused Approach (SFA)
- Keywords
- Mother having a preterm infant, Preterm infants care, Anxiety level, Solution-Focused Approach, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution-Focused Approach (SFA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Solution-Focused Approach (SFA) | Experimental | 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. Receives: Behavioral: Solution-Focused Approach (SFA) |
| Standard Care Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Score
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.
Measured: At baseline; one week after completion of the intervention; 2-month after completion of the intervention
Trait Anxiety Score
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.
Measured: At baseline; one week after completion of the intervention; 2-month after completion of the intervention
Secondary outcomes (2)
Solution-Focused Thinking Skills Score
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.
Measured: At baseline; one week after completion of the intervention; 2-month after completion of the intervention
Home Care Needs Competence
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.
Measured: At baseline; one week after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start20 Sep 2019
- Primary completion20 Sep 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nurcan Akgül Gündoğdu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nurcan Akgül Gündoğdu, Bandırma Onyedi Eylül University
- Investigators
- Nurcan AKGUL GUNDOGDU, PhD, Assoc. Prof., Principal investigator, Bandirma Onyedi Eylül University, Faculty of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401043
- Sponsor's protocol ID
- BANÜ-SBF-NAG-01
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Solution-Focused Approach on Mothers Anxiety About Preterm Infants Care
- ClinicalTrials.gov ID
- NCT07401043
- Acronym / sponsor ID
- BANÜ-SBF-NAG-01
- Conditions
- Maternal Anxiety
- Keywords
- Mother having a preterm infant, Preterm infants care, Anxiety level, Solution-Focused Approach, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nurcan Akgül GündoğduUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Solution-Focused Approach (SFA) | Experimental | Behavioral: 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. |
| Standard Care Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Solution-Focused Approach (SFA) |
Primary outcome
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.
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.
2 secondary outcomes
Solution-Focused Thinking Skills Score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurcan AKGUL GUNDOGDU, PhD, Assoc. Prof. principal investigator
Bandirma Onyedi Eylül University, Faculty of Health Sciences, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solution-Focused Approach (SFA) in people with Maternal Anxiety, run by Nurcan Akgül Gündoğdu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Score (time frame: At baseline; one week after completion of the intervention; 2-month after completion of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.