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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:
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfetalness Alone | Active Comparator | Participants in this group will:
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| Tele-Nursing-Supported Mindfetalness | Active Comparator | Participants in this group will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-Nursing-Supported Mindfetalness | Behavioral | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Only females are eligible to participate due to the nature of the pregnancy-related intervention.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Büşra Boğa, Research Assistant, MSc | Contact | +90 03742534520 | 6124 | busra.boga@ibu.edu.tr |
| Gülnur Yıldırım, Midwifery, MSc | Contact | +90 03742534626 | gulnur.yildirim@saglik.gov.tr |
| Name | Affiliation | Role |
|---|---|---|
| Nevin ÇITAK BİLGİN, Associate Professor, PhD | Abant Izzet Baysal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bolu Abant Izzet Baysal University | Bolu | 14030 | Turkey (Türkiye) |
Individual participant data will not be shared to protect the confidentiality and privacy of the participants.
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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.
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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.
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| Mindfetalness Alone | Behavioral | 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. |
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| 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. |