Fetal Movement, Tele-nursing
Conditions
Keywords
maternal anxiety, prenatal attachment, mindfetalness, tele-nursing, randomized controlled trial, mixed methods
Brief 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.
Interventions
BEHAVIORALTele-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.
BEHAVIORALMindfetalness 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.
Sponsors
Abant Izzet Baysal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Eligible pregnant women providing informed consent will be allocated to one of two groups (1:1 ratio) via a computer-generated simple randomization list (randomizer.org) managed by an independent researcher. To minimize bias, a double-blind design is employed. Participants will undergo an equivalent training procedure. Whilst participants will be aware that they are part of the study and that they will be contacted, they will be blinded to which group the tele-nursing support is allocated to. Group assignments will be kept confidential from the researcher administering the initial training. Blinding is ensured by preventing this researcher from knowing the participant's assigned group, thereby guaranteeing that the training is provided in a standardized and uniform manner across both groups.
Intervention model description
The study design is a prospective, two-arm (two experimental groups), parallel-group, double-blind, individual-randomised, and embedded mixed-methods clinical trial. This trial will be reported following the CONSORT, COREQ and GRAMMS statement. While quantitative data for the study are being collected, qualitative data will be collected from participants who have completed the research process (participants in the eighth week of the intervention).To capture the subjective depth of the Mindfetalness experience, qualitative interviews were integrated to enrich the quantitative findings on maternal anxiety and prenatal attachment. This mixed-methods approach provides a holistic understanding of the intervention's impact from the participants' perspective.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the Mindfetalness method (Daily Adherence 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). | 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. |
| Healthcare Utilization for Perceived Reduced Fetal Movement | 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. |
| The subjective effects, experiences and satisfaction levels of the intervention among pregnant women (Semi-structured interview form) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBüşra Boğa, Research Assistant, MSc
CONTACTGülnur Yıldırım, Midwifery, MSc
PRINCIPAL_INVESTIGATORNevin ÇITAK BİLGİN, Associate Professor, PhD
Abant Izzet Baysal University
Outcome results
None listed