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Recruiting Not applicable

Tele-Nursing-Supported Mindfetalness: Anxiety and Prenatal Attachment

NCT07507721 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-04-15
Last updated
2026-08-06

Condition(s) studied

Tele-nursingFetal Movement

Investigational drug(s) / intervention(s)

Tele-Nursing-Supported MindfetalnessMindfetalness Alone

Tele-Nursing-Supported Mindfetalness: 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.

Mindfetalness Alone: 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.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

  • Maternal state anxiety (State-Trait Anxiety Inventory) — 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.
  • Maternal Trait Anxiety (State-Trait Anxiety Inventory) — 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.
  • Prenatal Attachment (Prenatal Attachment Inventory) — 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.

Trial sites (2)

FacilityCityRegionStatus
Abant Izzet Baysal University Izzet Baysal Training and Research Hospital Bolu Turkey (Türkiye) Recruiting
Bolu Abant Izzet Baysal University Bolu Turkey (Türkiye) Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07507721 on ClinicalTrials.gov ↗ ← All trials in Turkey