Tele-Nursing-Supported Mindfetalness: Anxiety and Prenatal Attachment

Official title

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

Overview

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.

Interventions

• 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
• 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.

Primary outcome measures

• 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.]
• 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.]
• 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.]

Secondary outcome measures (3)

• 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).]
• Healthcare Utilization for Perceived Reduced Fetal Movement [Time frame: 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) [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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 2 centers

• Abant Izzet Baysal University Izzet Baysal Training and Research Hospital — Bolu
• Bolu Abant Izzet Baysal University — Bolu

Identifiers

NCT: NCT07507721 · AIBU-HEM-BB-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗