The Effect of Tele-nursing-Supported Mindfetalness Method on Maternal Anxiety and Prenatal Attachment: A Mixed Methods Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Maternal state anxiety (State-Trait Anxiety Inventory)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Mindfetalness Alone (Behavioral)
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.
干预措施: Tele-Nursing-Supported Mindfetalness (Behavioral)
结局指标
主要结局
Maternal state anxiety (State-Trait Anxiety Inventory)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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).)
- Healthcare Utilization for Perceived Reduced Fetal Movement(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)(Qualitative data will be collected at the end of week 8, following the completion of the 8-week intervention and final quantitative assessments.)
研究者
Büşra Boğa
Research Assistant
Abant Izzet Baysal University