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NCT Number: NCT07507721

Tele-Nursing-Supported Mindfetalness: Anxiety and Prenatal Attachment

The goal of this clinical trial is to compare the effects of tele-nursing-supported Mindfetalness method versus Mindfetalness alone method on maternal anxiety and prenatal attachment in pregnant women. The main questions it aims to answer are:

* H1: Tele-nursing-supported Mindfetalness method will significantly reduce state anxiety (STAI-S) levels in pregnant women over time compared to Mindfetalness alone method. * H2: Tele-nursing-supported Mindfetalness method will significantly reduce trait anxiety (STAI-T) levels in pregnant women over time compared to Mindfetalness alone method. * H3: Tele-nursing-supported Mindfetalness method will significantly increase prenatal attachment (PAI) levels in pregnant women over time compared to Mindfetalness alone method.

Researches will compare tele-nursing-supported Mindfetalness to Mindfetalness alone to see if tele-nursing support significiantly reduces state and trait anxiety levels and significiantly increases prenatal attachment levels in pregnant women over time.

Participants will;

* Attend a single, face-to-face Mindfetalness training session at the beginning of the study to learn technique and application procedures correctly. * Practice Mindfetalness method daily for 15 minutes throughout the 8-week study period. * Complete a daily compliance tracking chart to record their adherence to the Mindfetalness method of their practice. * Complete the State-Trait Anxiety Inventory (STAI) and the Prenatal Attachment Inventory (PAI) at baseline and during 4th and 8th-week follow-up measurements to track changes over time.

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Key information

Conditions

Tele-nursing Fetal Movement

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Abant Izzet Baysal University Izzet Baysal Training and Research Hospital, Bolu, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Being at the 28th week of gestation
  • Having a singleton pregnancy
  • Being primiparous
  • Being literate
  • Having access to and the ability to use a mobile device and internet connection (personal or via spouse) compatible with the tele-nursing application
  • Volunteering to participate in the study and providing informed consent (Araştırmaya katılmaya gönüllü olmak ve bilgilendirilmiş onam vermek)

Exclusion criteria

  • Having a high-risk pregnancy (e.g., preterm labor threat, preeclampsia, gestational diabetes, placenta previa, or cardiac disease).
  • Presence of diagnosed fetal health complications (e.g., intrauterine growth restriction [IUGR], fetal anomalies).
  • Currently monitoring fetal movements using any other conventional fetal movement counting methods.
  • Presence of any communication barriers (e.g., hearing, speech, or language impairments).
  • History or current diagnosis of chronic or psychiatric illness.
  • Conception through assisted reproductive techniques (ART) (e.g., IVF).

Treatment and study plan

Tele-Nursing-Supported Mindfetalness

Behavioral

The intervention involves the Mindfetalness method, a subjective practice focused on sensing the quality of fetal movements rather than numerical counting. All participants receive a single, face-to-face training session and are instructed to practice the method for 15 minutes daily throughout the 8-week study period. Adherence is monitored via a daily compliance tracking chart, with photos of the logs submitted to researchers at weeks 4 and 8. Tele-nursing-supported uniquely receives additional tele-nursing support, consisting of weekly motivational SMS reminders and two structured phone consultations (at weeks 2 and 6) to provide professional guidance and emotional support, ensuring the method is applied correctly and addressing participants' concerns.

Other names: Tele-nursing-supported Mindfetalness method, Mindfetalness Training for Fetal Movement Awareness

Mindfetalness Alone

Behavioral

The intervention involves the Mindfetalness method, a subjective practice focused on sensing the quality of fetal movements rather than numerical counting. All participants receive a single, face-to-face training session and are instructed to practice the method for 15 minutes daily throughout the 8-week study period. Adherence is monitored via a daily compliance tracking chart, with photos of the logs submitted to researchers at weeks 4 and 8.

Other names: Mindfetalness Training for Fetal Movement Awareness

Primary outcomes

  1. Maternal state anxiety (State-Trait Anxiety Inventory)

    Time frame: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.

    It will be used to assess maternal state anxiety levels. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so). The total score ranges from 20 to 80, with higher scores indicating higher levels of state anxiety. In the Turkish adaptation of the scale, the Cronbach's alpha reliability coefficient was reported as 0.94.

  2. Maternal Trait Anxiety (State-Trait Anxiety Inventory)

    Time frame: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.

    It will be used to assess maternal trait anxiety levels. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so). The total score ranges from 20 to 80, with higher scores indicating higher levels of trait anxiety. In the Turkish adaptation of the scale, the Cronbach's alpha reliability coefficient was reported as 0.83.

  3. Prenatal Attachment (Prenatal Attachment Inventory)

    Time frame: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.

    It will be used to assess the level of attachment between pregnant women and their babies. The inventory is a four-point Likert-type scale, with each item scored on a scale of 1 to 4, and consists of a total of 21 items. The total score ranges from 21 to 84, with higher scores indicating higher levels of prenatal attachment. The Crohnbach's alpha consistent for the Turkish version of the scale is 0.84.

Secondary outcomes

  1. Adherence to the Mindfetalness method (Daily Adherence Log)

    Time frame: To verify adherence, participants are required to submit photographs of the completed forms via a secure messaging platform (WhatsApp) at the end of week 4 (first form) and week 8 (second form).

    To ensure protocol fidelity and correct application, a researcher-developed adherence log was utilized, featuring detailed Mindfetalness guidelines on the reverse side. The log includes designated fields for recording the date and time of each session, along with checkboxes for 28 consecutive days of practice. Following the initial training, participants are provided with two copies of the log.

  2. Healthcare Utilization for Perceived Reduced Fetal Movement

    Time frame: Hospital admissions will be recorded and evaluated at the end of weeks 4 and 8.

    This outcome measures the frequency of hospital or outpatient clinic applications made by participants due to a perceived decrease in fetal activity, where subsequent clinical evaluations (e.g., Non-Stress Test or ultrasonography) confirmed normal fetal health (fetal well-being). Data will be collected via self-report questions integrated into the online follow-up forms.

  3. The subjective effects, experiences and satisfaction levels of the intervention among pregnant women (Semi-structured interview form)

    Time frame: Qualitative data will be collected at the end of week 8, following the completion of the 8-week intervention and final quantitative assessments.

    The questionnaire developed by the researchers will include five open-ended questions asking pregnant women about their subjective perceptions, experiences and satisfaction regarding the research process and the Mindfetalness method. Some of the questions have been supplemented with follow-up questions.

Study contacts

Contact information is provided by the study sponsor or research team.

Büşra Boğa, Research Assistant, MSc

CONTACT

[email protected]

+90 03742534520 ext. 6124

Gülnur Yıldırım, Midwifery, MSc

CONTACT

[email protected]

+90 03742534626

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

The Effect of Tele-nursing-Supported Mindfetalness Method on Maternal Anxiety and Prenatal Attachment: A Mixed Methods Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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