Tele-Nursing-Supported Mindfetalness: Anxiety and Prenatal Attachment

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fetal Movement; Tele-nursing
• Intervention / Treatment: Behavioral: Mindfetalness Alone; Behavioral: Tele-Nursing-Supported Mindfetalness

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Büşra Boğa, Research Assistant, MSc; Phone Number: 6124 +90 03742534520; Email: busra.boga@ibu.edu.tr
• Study Contact Backup: Name: Gülnur Yıldırım, Midwifery, MSc; Phone Number: +90 03742534626; Email: gulnur.yildirim@saglik.gov.tr

Study Locations

• Turkey (Türkiye)
  • Bolu, Turkey (Türkiye), 14030
    • Bolu abant Izzet Baysal University
    • Contact: Büşra Boğa, PhD Student; Phone Number: 6124 +90 374 253 45 20; Email: busra.boga@ibu.edu.tr
    • Principal Investigator: Nevin Çıtak Bilgin, Associate Professor, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mindfetalness Alone; Participants in this group will: Complete the baseline assessments (pre-test) prior to the intervention.; Receive a standardized training session on the Mindfetalness method.; Be provided with a compliance tracking chart to monitor their daily practice.; Perform the Mindfetalness application daily for 15 minutes throughout the intervention period.; Submit photographs of their compliance tracking charts to the researchers at week 4 and week 8 to document to the method.; Undergo follow-up measurements at week 4 and week 8 to evaluate the ongoing effects of the intervention.; Following the completion of the research, participants who volunteered for the qualitative phase will be identified, and randomly selected individuals from this volunteer pool will be invited to participate in the interviews to ensure diverse perspectives.	Behavioral: 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.; Other Names: Mindfetalness Training for Fetal Movement Awareness
Active Comparator: Tele-Nursing-Supported Mindfetalness; Participants in this group will: Complete the baseline assessments prior to the intervention.; Receive a standardized training session on the Mindfetalness method.; Be provided with a compliance tracking chart to monitor their daily practice.; Perform the Mindfetalness application daily for 15 minutes throughout the intervention period.; Receive weekly SMS reminders throughout the study to encourage consistent practice and maintain motivation for the Mindfetalness method.; Participate in tele-nursing consultation calls during the 2nd and 6th weeks of the intervention to receive guidance, address concerns, and obtain emotional support regarding the method.; Submit photographs of their compliance tracking charts to the researchers at week 4 and week 8 to document to the method.; Undergo follow-up measurements at week 4 and 8 to evaluate the ongoing effects of the intervention.; Post-intervention, random interviews will be conducted with volunteer participants to gain deeper insights.	Behavioral: 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.; Other Names: Tele-nursing-supported Mindfetalness method; Mindfetalness Training for Fetal Movement Awareness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal state anxiety (State-Trait Anxiety Inventory)	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.	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.
Maternal Trait Anxiety (State-Trait Anxiety Inventory)	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.	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.
Prenatal Attachment (Prenatal Attachment Inventory)	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the Mindfetalness method (Daily Adherence Log)	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.	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).
Healthcare Utilization for Perceived Reduced Fetal Movement	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.	Hospital admissions will be recorded and evaluated at the end of weeks 4 and 8.
The subjective effects, experiences and satisfaction levels of the intervention among pregnant women (Semi-structured interview form)	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.	Qualitative data will be collected at the end of week 8, following the completion of the 8-week intervention and final quantitative assessments.

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University
• Investigators: Principal Investigator: Nevin ÇITAK BİLGİN, Associate Professor, PhD, Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; prenatal attachment; mixed methods; maternal anxiety; mindfetalness; tele-nursing
• Other Study ID Numbers: AIBU-HEM-BB-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect the confidentiality and privacy of the participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No