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To Examine the Effects of Mobile App Support Provided to Expectant Fathers, Based on Transition Theory, on Anxiety, Bonding With the Fetus, and Marital HarmonyNCT07767045

MOBİLE APP SUPPORT BASED ON TRANSİTİON THEORY FOR EXPECTANT FATHERS

A study testing Mobile app support in people with To Examine the Effects of Mobile App Support Provided to Expectant Fathers, Based on Transition Theory, on Anxiety, Bonding With the Fetus, and Marital Harmony, run by Ege University at 2 sites in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

THİS STUDY; İS DESİGNED TO EXAMİNE THE EFFECTS OF A MOBİLE APPLİCATİON-DEVELOPED BASED ON TRANSİTİON THEORY-PROVİDED TO EXPECTANT FATHERS ON ANXİETY, FETAL BONDİNG, AND MARİTAL ADJUSTMENT. Read more about this study

Who is it for?
Any age, men only
What is being tested?
Mobile app support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Sep 2026to 15 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Be 18 years of age or older and able to speak and understand Turkish
  • Have completed at least elementary school
  • Your spouse must be between the 26th and 28th weeks of pregnancy
  • This must be the first parenting experience for both you and your spouse
  • Own a smartphone or tablet capable of downloading a mobile app
  • Have verbally and in writing agreed to participate in the study following a briefing about the research

Who cannot join

  • Visually impaired individuals
  • Individuals with psychiatric disorders

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Duygu G GÜLEÇ ŞATIR contact

+905542477904

duygugulec50@hotmail.com

Turkey (Türkiye)2 sites
  • Ege University

    Izmir, Urla

    Mustafa Ulusoy, 02327521004, urladh.ozluk@saglik.gov.tr

    Sinem Kurt, 05348863323, sinemcalliege@gmail.com

  • Ege Üniversitesi

    Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: THE EFFECT OF MOBİLE APP SUPPORT BASED ON TRANSİTİON THEORY ON ANXİETY, FETAL BONDİNG, AND MARİTAL ADJUSTMENT AMONG EXPECTANT FATHERS

THİS STUDY; İS DESİGNED TO EXAMİNE THE EFFECTS OF A MOBİLE APPLİCATİON-DEVELOPED BASED ON TRANSİTİON THEORY-PROVİDED TO EXPECTANT FATHERS ON ANXİETY, FETAL BONDİNG, AND MARİTAL ADJUSTMENT. CONDUCTED AS PART OF A DOCTORAL DİSSERTATİON, THE RESEARCHERS AİM TO SUPPORT EXPECTANT FATHERS' ADAPTATİON TO THE PREGNANCY AND CHİLDBİRTH PROCESS, REDUCE THE ANXİETY THEY MAY EXPERİENCE DURİNG THİS PERİOD, STRENGTHEN THE FETAL BOND WİTH THEİR BABİES, AND İMPROVE THEİR MARİTAL ADJUSTMENT WİTH THEİR PARTNERS. FACİLİTATİNG ACCESS TO İNFORMATİON AND PROVİDİNG SUPPORT THROUGH A MOBİLE APPLİCATİON OFFERS AN İNNOVATİVE APPROACH İNTEGRATED WİTH MODERN TECHNOLOGY.

PLANNED AS A RANDOMİZED CONTROLLED TRİAL, THİS STUDY WİLL BE CONDUCTED WİTH EXPECTANT FATHERS WHOSE PARTNERS ARE BETWEEN 26 AND 28 WEEKS OF GESTATİON AND WHO ATTEND THE OBSTETRİCS CLİNİC AT URLA STATE HOSPİTAL TOGETHER. THE STUDY SAMPLE WİLL CONSİST OF A TOTAL OF 96 EXPECTANT FATHERS (PARTİCİPANTS)-48 İN THE CONTROL GROUP AND 48 İN THE İNTERVENTİON GROUP-SELECTED VİA BLOCK RANDOMİZATİON BASED ON İNCLUSİON CRİTERİA.

Read more

PARTİCİPANTS İN THE İNTERVENTİON GROUP WİLL RECEİVE AN 8-WEEK EDUCATİONAL PROGRAM VİA THE "FATHERHOOD JOURNEY" MOBİLE APPLİCATİON, WHİCH WAS DEVELOPED BASED ON MELEİS'S TRANSİTİON THEORY, GROUNDED İN THE LİTERATURE, AND REVİSED İN ACCORDANCE WİTH EXPERT OPİNİONS TO MEET THE NEEDS OF FATHERS DURİNG PREGNANCY AND CHİLDBİRTH. PARTİCİPANTS İN THE CONTROL GROUP WİLL RECEİVE NO İNTERVENTİON.

DATA WİLL BE COLLECTED AT TWO DİFFERENT TİME POİNTS: PRE-TEST (BETWEEN 26-28 WEEKS OF GESTATİON) AND POST-TEST (BETWEEN 34-36 WEEKS OF GESTATİON). DATA COLLECTİON WİLL BE CARRİED OUT VİA AN ONLİNE PLATFORM USİNG THE PERSONAL INFORMATİON FORM, THE PATERNAL ANTENATAL ANXİETY SCALE, THE PATERNAL ANTENATAL ATTACHMENT SCALE, AND THE MARİTAL ADJUSTMENT SCALE.

FOR İNTERGROUP COMPARİSONS OF QUANTİTATİVE DATA, THE MANN-WHİTNEY U TEST WİLL BE USED FOR VARİABLES THAT DO NOT FOLLOW A NORMAL DİSTRİBUTİON, AND THE INDEPENDENT SAMPLES T-TEST WİLL BE USED FOR NORMALLY DİSTRİBUTED VARİABLES. TO EVALUATE WİTHİN-GROUP PRE-TEST AND POST-TEST SCORE DİFFERENCES FOR THE CONTROL AND EXPERİMENTAL GROUPS, THE PAİRED SAMPLES T-TEST WİLL BE USED; İNTERGROUP COMPARİSONS OF PRE-TEST AND POST-TEST CHANGE SCORES WİLL BE CONDUCTED USİNG THE INDEPENDENT SAMPLES T-TEST. THESE COMPARİSONS WİLL BE PERFORMED SEPARATELY FOR EACH SCALE. FOR WİTHİN-GROUP FOLLOW-UP COMPARİSONS OF QUANTİTATİVE DATA THAT DO NOT FOLLOW A NORMAL DİSTRİBUTİON, THE FRİEDMAN TEST AND WİLCOXON SİGNED-RANK TEST WİLL BE APPLİED. ANALYSİS TABLES WİLL BE CREATED, STATİSTİCAL İNTERPRETATİONS WİLL BE PERFORMED, AND THE RESULTS WİLL BE EVALUATED AT A 95% CONFİDENCE İNTERVAL AND A SİGNİFİCANCE LEVEL OF P < 0.05.

Read the detailed description

Here is the English version of the introduction/background text, thoroughly revised to ensure a completely objective, third-person academic tone suitable for publication or official documentation:

---

Pregnancy is a critical period that involves significant physical, emotional, and psychological changes not only for expectant mothers but also for expectant fathers. Expectant fathers-particularly those preparing for parenthood for the first time-may experience ambivalent and complex emotions from the very beginning of pregnancy. Couples frequently encounter feelings of fear, uncertainty, worry, helplessness, and anxiety regarding the pregnancy and childbirth process, the health of the mother and baby, the postpartum period, and the acquisition of parental roles alongside increasing responsibilities. Potential complications arising during pregnancy or childbirth can further elevate stress and anxiety levels among expectant fathers. Although a certain level of fear regarding childbirth is considered natural, an intensification of this fear can lead to adverse health outcomes for both the father and the overall family system.

The difficulties and elevated anxiety encountered during pregnancy directly affect men's self-concept, identity perception, and relationships with their partner and unborn child, thereby increasing the risk of stress, anxiety, and depression. Furthermore, these challenges can contribute to marital conflicts and lead to poorer outcomes in children's overall, social-emotional, cognitive, language, and physical development.

Researchers widely agree that the foundation of parent-infant attachment is established during the prenatal (antenatal) period. Throughout this process, expectant parents develop a dynamic relationship with their unborn child. Although early studies primarily focused on maternal-infant attachment, research on paternal antenatal (fetal) attachment has gained significant momentum in recent years. The sense of attachment developed by the father prior to birth plays a critical role in establishing a healthy parent-child relationship in the postpartum period. Healthy early attachment supports long-term behavioral and emotional development in children. Consequently, designing intervention studies aimed at strengthening paternal attachment is of paramount importance.

The transition to fatherhood is a process just as complex, dynamic, and demanding as the transition to motherhood. Guiding and supporting expectant fathers through this transitional period represents one of the core professional roles and responsibilities of nurses. Afaf Meleis, whose theoretical work centers on life transition processes, highlighted the specific challenges couples face during the transition from pregnancy to parenthood. Meleis's "Transition Theory" focuses on the family and key support systems. Meleis posited that the primary area requiring development is not merely the transition itself, but rather the nursing interventions designed to facilitate healthy transition outcomes for individuals. The theoretical framework is structured around the concepts of "role deficit" and "role support." Within this context, "role" refers not merely to expected behavioral patterns, but to an integrated set of emotions and goals that organize prospective responsibilities. Role transitions denote meaningful shifts in relationships, expectations, and capabilities, with the transition to fatherhood standing out as a prime example of a developmental role transition.

In the process of transitioning to fatherhood, marital adjustment emerges as a vital determinant. Marital adjustment refers to the overall level of happiness and satisfaction spouses derive from their union as a result of fulfilling mutual roles, responsibilities, and emotional expectations. Implementing awareness-based interventions aimed at enhancing marital adjustment supports psychological well-being, improves emotional regulation skills, and fosters empathic capacity between partners.

The integration of technology into healthcare represents a promising innovation for improving care quality, broadening service access, and ensuring cost-effectiveness. Mobile technologies are among the fastest-adopted tools in human history, offering low-cost communication and widespread reach. Global data indicates that mobile internet usage accounts for a substantial proportion of daily online activity across diverse demographic groups. Mobile health applications are actively utilized across numerous domains, including education, two-way communication, reminders, health monitoring, data collection, and health literacy enhancement. Because mobile applications are accessible independent of time and location, they enable users to access critical support and skills at the exact moment of need.

Within the framework of family-centered care, testing the efficacy of mobile health applications among expectant fathers-rather than limiting these technologies exclusively to pregnant women-remains an important need in the literature. Although paternal mental health issues during the perinatal period represent a significant public health concern, evidence-based intervention studies targeting fathers remain remarkably sparse. Fathers frequently encounter barriers to traditional clinic appointments due to work commitments, caregiving responsibilities, and social stigmas surrounding mental health. Consequently, digital and mobile app-based interventions offer a highly acceptable, feasible, and effective alternative by delivering flexible, high-accessibility psychoeducation and support.

Despite the demonstrated feasibility of digital tools, high-quality studies directly targeting fathers' perinatal mental health remain insufficient. Paternal anxiety directly and negatively impacts both the spousal relationship and the paternal-fetal attachment process. In this project, the concepts of anxiety, fetal attachment, and marital adjustment are addressed conjointly to holistically evaluate the psychological, relational, and parental dimensions of the transition to fatherhood. An expectant father experiencing elevated anxiety may feel inadequate regarding his parental role, directing his cognitive and emotional resources toward internal fears. This shift can impair marital adjustment and hinder the formation of a strong emotional bond with the unborn baby. Conversely, fathers who maintain a supportive and harmonious relationship with their partners tend to adopt the paternal role more readily.

Ultimately, interactive content provided via a dedicated mobile application (such as weekly fetal development updates and father-specific informational guidance) is anticipated to increase paternal awareness, reduce anxiety, support marital adjustment, and directly strengthen paternal-fetal bonding.

Being tested
Mobile app support
Keywords
father-child, anxiety, marital harmony, mobile app, andomized controlled trial
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile app supportOther

    The training, which will be provided via a mobile app, is designed to examine its impact on variables such as marital harmony, pregnancy anxiety, and fetal bonding among expectant fathers

Study groups in NCT07767045
Study groupRoleWhat they receive
Control groupsNo interventionNo intervention will be performed on the control group.
Experimental groupsExperimentalExpectant fathers whose partners are pregnant will receive training through a mobile app.
Receives: Other: Mobile app support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Anxiety Scores on the Paternal Antenatal Anxiety Scale (PAAS) at 8 Weeks Post-Intervention)

    Assessed using the Paternal Antenatal Anxiety Scale (PAAS). The scale measures pregnancy-specific anxiety levels in expectant fathers. Assessed using the Paternal Antenatal Anxiety Scale (PAAS). The total score is calculated by dividing the sum of all item scores by the total number of items (10), resulting in a score range from 1 to 4. Higher scores indicate higher levels of anxiety.

    Measured: Baseline (26-28 weeks of gestation) and 8 weeks post-intervention (34-36 weeks of gestation

  2. Change from Baseline in Dyadic Adjustment Scale (DAS) Scores at 8 Weeks Post-Intervention

    Assessed using the Dyadic Adjustment Scale (DAS). The scale consists of 32 items and measures overall relationship quality and marital adjustment in couples. Total scores range from 0 to 151, with higher scores indicating higher levels of marital adjustment and relationship quality.

    Measured: Baseline, 8 weeks post-intervention

  3. Change from Baseline in Paternal Antenatal Attachment Scale (PAAS) Scores at 8 Weeks Post-Intervention

    Assessed using the Paternal Antenatal Attachment Scale (PAAS). The scale consists of 16 items measuring the emotional bond and attachment of expectant fathers to their unborn child. Total scores range from 16 to 80, with higher scores indicating higher levels of paternal-fetal attachment.

    Measured: Baseline, 8 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Sep 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07767045
Sponsor's protocol ID
25-7T/13
Status last verified
Aug 2026
First submitted
23 Jul 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to protect participant confidentiality and privacy.

Questions about this trial

What is this clinical trial studying?

A study testing Mobile app support in people with To Examine the Effects of Mobile App Support Provided to Expectant Fathers, Based on Transition Theory, on Anxiety, Bonding With the Fetus, and Marital Harmony, run by Ege University at 2 sites 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 2 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Duygu G GÜLEÇ ŞATIR (+905542477904, duygugulec50@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Anxiety Scores on the Paternal Antenatal Anxiety Scale (PAAS) at 8 Weeks Post-Intervention) (time frame: Baseline (26-28 weeks of gestation) and 8 weeks post-intervention (34-36 weeks of gestation). The study lists 3 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 17 Aug 2026.

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