The first two sessions will focus primarily on face-to-face intervention on-site, with online intervention as a supplement, whereas the remaining four sessions will be online. Online interventions will be conducted via the WeChat platform, where mindfulness training audios are available. Participants can practice using these audios.
Intervention duration
Pregnancy mindfulness interventions typically include 6–8 sessions, with each session lasting 0.5–2 h [26]. This provides a basis for determining the duration of mindfulness intervention in this study. Taking into account the Chinese tradition of 30-day postpartum confinement, the intervention period extends from hospitalization for induced abortion to four weeks postpartum, with sessions lasting 1.5 to 2 h each.
Routine psychological care
The control group receives routine psychological care, graded care based on the psychological assessment of women upon admission [27]. Specific Content: (a) women in good psychological states receive general psychological comfort from nurses, explanations about fetal abnormalities, induced labor, postpartum care, and preparation for future pregnancies; (b) for women with mild to moderate psychological issues, nurses develop a psychological counseling plan involving family members; (c) women with severe psychological disorders require counseling under a psychological expert’s guidance or are advised to seek psychiatric psychotherapy. Researchers will offer MBCI and related guidance to participants at the study’s end, considering ethical concerns.
Intervention fidelity
A senior psychological counselor supervises the entire intervention process. The mindfulness intervention in this study is conducted by a psychological counselor who had received systematic mindfulness training. The mindfulness exercise audios are recorded by this counselor. Participants engage in mindfulness exercises through the WeChat platform and complete feedback forms there. Researchers promptly analyze mindfulness exercise feedback, address issues, and communicate with participants online, encouraging daily engagement.
Measurement instruments
The personal information form includes two sections: demographic characteristics (age, education level, occupation, religious beliefs, income level, personality traits, marital status, living conditions, living arrangements) and obstetric characteristics (pregnancy and childbirth history, history of abnormal pregnancies, gestational age, pregnancy intentions, fertilization method, fetal abnormality diagnosis).
Mindfulness exercise feedback form created by researchers will be used to gather insights into participants’ mindfulness exercise experiences. It covers exercise duration, challenges faced, feelings during the exercise, satisfaction with the intervention (content, methodology, duration), and any suggestions for improvement.
The Generalized Anxiety Disorder Scale (GAD-7) assesses anxiety severity and functional impairment over the past two weeks with 7 items, each scored from 0 to 3. Scores range from 0 to 21, where 0–4 indicate no anxiety, 5–9 mild anxiety, 10–14 moderate anxiety, and ≥ 15 severe anxiety. The Chinese version is reliable and valid, with a Cronbach’s α of 0.92 [28].
The Patient Health Questionnaire (PHQ-9), a 9-item, 4-point scale, measures maternal depression. The PHQ-9, known for its simplicity and sensitivity, is commonly used to assess antenatal depression. Total scores, reflecting the sum of all items, indicate the severity of depressive symptoms: higher scores suggest more severe symptoms. Scoring Criteria: 0–4 points indicate no depression, 5–9 indicate mild depression, 10–14 indicate moderate depression, 15–19 indicate moderately severe depression, and above 19 indicate severe depression. The Chinese version’s Cronbach’s α coefficient, for use in pregnant is 0.89 [29].
Family Adaptation Partnership Growth Affection and Resolve index (Family APGAR), developed by Smilkstein [30] in 1978, assesses family functioning across five dimensions: adaptability, partnership, growth, affection, and resolve. It uses a 3-point rating scale: total scores of 7 to 10 signify good family functioning, 4 to 6 suggest moderate dysfunction, and 0 to 3 denote severe dysfunction. The scale has demonstrated high reliability and validity, with a Cronbach’s α coefficient of 0.85 [31]. In this study, the Family APGAR measures family support levels.
Five Facet Mindfulness Questionnaire (FFMQ) encompasses five dimensions: observation, description, conscious action, non-judgment, and non-reaction. The observation dimension aligns with mindful attention, while non-judgment and non-reaction align with acceptance. The FFMQ, consisting of 39 items rated on a five-point scale, higher total scores indicate elevated mindfulness levels. It exhibits good reliability and validity, with an internal consistency coefficient of 0.79 [32]. In this study, the FFMQ measures mindfulness levels.
Assessments
The demographic and obstetric characteristics will be collected at baseline. Qualified couples complete the GAD-7, PHQ-9, Family APGAR, and FFMQ scales upon admission, post-intervention, and 42 days postpartum. Additionally, they are expected to complete a mindfulness exercise feedback form weekly.
Semi-structured interviews with the intervention group are conducted post-intervention and 42 days postpartum. Interviews focus on participants’ experiences, engagement and acceptance of the intervention, as well as factors facilitating their physical and mental recovery, aiming to validate and refine the intervention model.
Childbirth outcome indicators collected post-labor induction will include the duration of each labor stage, the amount of bleeding during and post-labor, and the obstetric complication rate. The study’s schedule is shown in Table 2.
Statistical analysis
Sample size
To calculate the necessary sample size, the formula N1 = N2 = 2[(Zα + Zβ)S/δ]2 is used. Based on results from previous mindfulness intervention studies [21] on mental health symptoms, we derived values: S = 0.64, δ = 0.41, α = 0.05, and β = 0.10. Applying these values, the estimated total sample size is 104. Accounting for a 20% attrition rate and sampling error, the estimated sample size for each of the intervention and control groups is 62.
Plan of data analysis
Statistical analyses will be performed with SPSS 19.0 software. A database will be created using a dual data entry method, with logical checks to ensure data accuracy. Categorical data will be analyzed using rates and percentages, and continuous data will be described statistically as mean ± standard deviation. Baseline characteristics of the two groups will be analyzed using non-parametric tests, chi-square tests, or independent samples t-tests. Differences in scores (GAD-7, PHQ-9, Family APGAR, FFMQ) before and after the intervention will be compared between the two groups. For normally distributed data, repeated measures ANOVA will be used; for non-normally distributed data, generalized estimating equations will be applied. The threshold for statistical significance is set at P < 0.05.
Interviewees will be coded sequentially according to their interview times. Audio recordings will be transcribed into text within 24 h post-interview, including documentation of non-verbal behaviors. Data will be analyzed, refined, and coded independently by at least two researchers using Colaizzi’s 7-step method. ① Reading all interview materials carefully; ② annotating important statements; ③ coding recurring viewpoints; ④ consolidating coded viewpoints into themes; ⑤ writing detailed and comprehensive descriptions; ⑥ summarizing similar viewpoints; ⑦ verifying with interviewees via phone calls, WeChat, or follow-up interviews.
Ethics and dissemination
The Women’s Hospital School of Medicine, Zhejiang University’s ethics committee reviewed the study proposal in detail, offering feedback on its design and methods. To protect participant rights, researchers will explain the study’s purpose, process, risks, and benefits to eligible participants, answering all questions to ensure full understanding. Participants will receive an easily understandable informed consent form and have ample time to decide on their participation. If participants decide to participate voluntarily, they will sign the informed consent form. The ethics committee of the Women’s Hospital School of Medicine, Zhejiang University (IRB-20220093-R), has approved this study.
Protocol amendments
Any modifications to the research protocol must be resubmitted for ethical review and approval by the ethics committee. Significant modifications will be communicated to the principal investigators involved.
Adverse events
During the study, clinical adverse events (AEs), including serious adverse events (SAEs), must be reported verbally to the ethics committee and all investigators within 24 h, followed by a written report within three days. The written report, adhering to the ethics committee’s required format, will detail the occurrence time, SAE description, severity rating (Grade 1 to 4), cause, treatment process and duration, and outcome. All adverse events must be monitored until resolution or stabilization of the condition.
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