Tele-Nursing-Supported Mindfetalness: Anxiety and Prenatal Attachment

Abant Izzet Baysal University

Status: Not yet enrolling

Conditions: Fetal Movement; Tele-nursing

Treatments: Behavioral: Mindfetalness Alone; Behavioral: Tele-Nursing-Supported Mindfetalness

Study type: Interventional

Funder types: Other

Identifiers

NCT07507721

AIBU-HEM-BB-03

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Mindfetalness Alone

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mindfetalness Alone

Tele-Nursing-Supported Mindfetalness

Active Comparator group

Description:

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.

Treatment:

Behavioral: Tele-Nursing-Supported Mindfetalness