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The required sample size was calculated using statistical power analysis. The score of the Delivery Expectancy/Experience Questionnaire (W-DEQ) was taken as the reference based on previous studies[45], and a statistical power of 0.90 was used to reject a null effect at the 0.05 level of significance. A minimum sample size of 37 for each group was calculated and 74 in total. After taking into account a possible attrition rate of 20%, a target sample size of 93 participants was set.
We created random grouping sequences using the Statistical Analysis System (SAS) for Windows (Version 9.1, SAS institute, Cary, NC, USA) and assigned participants to a control group or an intervention group using a 1:1 ratio based on their time of enrollment.
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Pregnant women capable of full Chinese communication with a single pregnancy at 20–32 weeks of gestation who had set up a registry at the target hospital and planned to have a prenatal examination, in-hospital delivery, and postnatal review at the hospital were included. Furthermore, the participants should have a high school education or above and have no serious pregnancy complications or diseases. Pregnant women who were diagnosed with psychosis, undergoing any form of psychological therapy, or taking psychotropic medications were excluded. Pregnant women who had repeated abortions, PTB, or a history of epilepsy were also excluded. We initially selected 104 women to participate in the study based on the inclusion criteria (Figure 1).
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The intervention group received a 4-day on-site localized MBCP course during weekends for four consecutive weeks, with the first, second, and fourth weekends lasting 2.5 h and the third weekend lasting 6.5 h. The total on-site intervention time was 14 h. The course was conducted face-to-face in small groups by two MBCP teachers with rich teaching experience. The course mainly comprised raisin meditation, breathing awareness, body scan, mindful yoga and meditation, labor pain cognitive education, and pain management with holding ice exercises (Table 1). After each on-site course, the intervention group practiced at home for 30–40 min per day, 6 days a week, with the recorded audio by the WeChat applet. The practice consisted of formal practice, such as mindful breathing, body scan, mindful yoga, and 3-min breathing space; and informal practice, such as mindful eating, mindful brushing teeth, mindful washing face, and other mindfulness practices in their daily lives. We invited the partners of the participants to accompany and participate in the on-site course and practice at home.
Week Content Week 1 Introduction to mindfulness and introduction of the teacher and the participants
Practice: mindfully eating a raisin and awareness of breathing meditation
Inquiry, sharing among participantsWeek 2 Practice: body scan meditation Week 3 Inquiry, sharing among participants
Psycho-education: introduction of the birth process and labor pain from a body-mind perspective
Practice: pain meditations by holding ice and practicing various pain-coping strategies and mindful yoga
Inquiry, sharing among participantsWeek 4 Review of the course: encouragement to continue practice in the future
Inquiry, sharing among participantsTable 1. Main content of the 4-week course
The intervention group also received the same regular health education as the control group. For 21 days, we provided an online childbirth education course with the recorded video by the WeChat applet for those in the control group, which lasted about 5–10 min per day. The course covered pregnancy-related physical and psychological knowledge and self-care skills during pregnancy and postpartum.
We helped and guided the two groups of participants to better complete the relevant study and exercises using the WeChat platform. We arranged for physicians to answer their questions related to pregnancy and childbirth using the WeChat platform.
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We collected the questionnaires before (T0) and after (T1) the intervention, 3 days after delivery (T2), and 42 days after delivery (T3) at the hospital clinic. All participants completed the Edinburgh Postnatal Depression Scale (EPDS), Self-Rating Anxiety Scale (SAS), Wijmam Delivery Expectancy/Experience Questionnaire (W-DEQ-A/B), Satisfaction with Life Scale (SWLS), and Five Facet Mindfulness Questionnaire (FFMQ) at each time point. For the post-intervention assessment, the participants completed the Course Satisfaction Questionnaire (CSQ) designed by our team, which measures the satisfaction of the participants with the course using 10-point scales ranging from 1 to 10; higher scores indicate greater satisfaction with the course. The questionnaire was collected face-to-face between the investigators and participants. The participants read and fill in the paper questionnaires by themselves. After questionnaire collection, we arranged for two researchers to double input the questionnaire information into the database with EpiData software (Version 3.1, EpiData Association, Denmark).
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The EPDS has ten items, and each item is scored from 0 to 3. The scores for each item were added to obtain the total score[46]. A prenatal EPDS score of > 13 was considered an indicator of depression[47]. Tsao et al.[48] used a cutoff value of 13 in a study involving the women in Taiwan, China. The Cronbach’s alpha ranged from 0.84 to 0.85 in our study.
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The SAS[49] is a self-report scale with 20 items covering various psychological and somatic anxiety symptoms. The participants respond on a four-point scale (1 = “none, or little time” to 4 = “most or all the time”). They answered the questions based on their experiences from the previous week. The original SAS score ranges from 20 to 80. SAS has shown satisfactory psychometric performance[50]. In our study, the Cronbach’s alpha ranged from 0.83 to 0.88.
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The W-DEQ-A/B assesses FOC during pregnancy and after childbirth. It is composed of 33 items that are scored using a six-point Likert-type scale, with 0 representing “extremely” and 5 representing “not at all.” The total score ranges from 0 to 165; the higher the score, the higher the FOC[51,52]. In our study, the Cronbach’s alpha ranged from 0.88 to 0.93 for questionnaire A and from 0.82 to 0.94 for questionnaire B.
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The SWLS[53] is a five-item self-report scale that primarily comprises questions concerned with personal life satisfaction. Responses are scored on a seven-point Likert-type scale (1 = “strongly disagree” and 7 = “strongly agree”). The Cronbach’s alpha ranged from 0.79 to 0.86 in our study.
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The FFMQ is based on factor analysis and contains 39 questions and five factors: observing, describing, acting with awareness, being non-judgmental of inner experience, and being non-reactive to inner experience. Responses are scored using a five-point Likert-type scale, with 1 representing “never or very rarely true” and 5 representing “very often or always true”[54]. The Cronbach’s alpha ranged from 0.78 to 0.85 in our study.
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The study protocol was approved by the Ethics Review Committee of the National Center for Women and Children (Approval no. FY2018-30, Chinese Center for Disease Control and Prevention, Beijing, China). Before recruitment, every pregnant woman who was interested in participating in the study received a detailed explanation of the purpose, significance, benefits, and potential risks of our study. Additionally, participants were informed regarding what they needed to do in the study and followed up to obtain their understanding and support. The participants provided informed consent. To keep the data confidential, all data collected were anonymous and prohibited for use outside of our study. The participants were informed that they had the right to withdraw from participation at any time during the study period without consequences.
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IBM SPSS Statistics for Windows version 24.0 (IBM Corp., Armonk, NY, USA) was used for data analysis. The demographic characteristics were summarized as the mean and standard deviation for measurement data and as frequency counts (percentages) for categorical variables. The chi-square test and Fisher’s exact test were used to evaluate the differences between the two groups of demographic variables (education level, marital status, and family income). Measurement data were analyzed using the t-test. Longitudinal data were analyzed using repeated-measures analysis of variance to compare the differences in scale scores of pregnant women at T0, T1, T2, and T3 between the two groups and the changes in scale scores of pregnant women at four time points within the same group.
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We interviewed a total of 104 participants, of which 6 were eliminated because they did not meet the criteria for inclusion (n = 3) or declined to participate (n = 3). Another 15 participants were excluded from further analysis because they were lost to follow-up (intervention group, n = 8; control group, n = 7; attrition rate = 15.3%). No statistically significant differences were found in the demographic characteristics of the participants who did (n = 83) and did not (n = 15) complete T2 measurements, including age, infant’s gestational age, body weight, education level, census register, marital status, household income, parity, pregnancy method, and pregnancy complications (P > 0.10). No statistically significant differences in demographic characteristics were noted between the intervention (n = 40) and control (n = 43) groups (Table 2, Figure 1). At the post-intervention assessment, 92.5% of the participants in the intervention group scored ≥ 8 on the CSQ, thus indicating that they were satisfied with the course.
Characteristics Intervention group (n = 40) Comparison group (43) χ2/t P Age (Mean ± SD) 31.83 ± 3.50 31.51 ± 3.00 0.45 0.66a Gestational age of infant (Mean ± SD) 26.23 ± 3.80 27.00 ± 4.10 0.89 0.38a Bodyweight (Mean ± SD) 63.19 ± 8.40 6.15 ± 9.15 0.88 0.38a Level of education, n (%) 0.42 0.52b Junior college or below 7 (15.9) 10 (23.3) University or above 33 (84.1) 33 (76.7) Census register, n (%) 0.41 0.52b Urban 26 (65.0) 25 (58.1) Rural 14 (35.0) 18 (41.9) Marital status, n (%) 1.00c Married 39 (97.5) 42 (97.8) Not married 1 (2.5) 1 (23.2) Income, n (%) 0.77 0.68b < ¥100,000 13 (32.5) 11 (25.6) ¥100,000–¥200,000 15 (37.5) 20 (46.5) > ¥200,000 12 (30.0) 12 (27.9) Parity, n (%) 0.13 0.72b 0 prior births 32 (80.0) 33 (76.7) ≥ 1 prior births 8 (20.0) 10 (23.3) Pregnancy way, n (%) 1.00c Pregnancy by nature 38 (95.0) 41 (95.3) Pregnancy by medicine 2 (5.0) 2 (4.7) Pregnancy complications, n (%) 1.84 0.18b No 33 (82.5) 30 (69.8) Yes 7 (17.5) 13 (30.2) Note. aChi-square test; bt-test; cFisher’s exact test. Significant at the 0.05 level. Table 2. Comparison of general information between the two groups
The longitudinal data analysis results are presented in Table 3 and Figures 2-6. Regarding depression, the overall results showed no significant difference between the groups (F = 3.80, P = 0.05). A significant difference was found at different times (F = 4.86, P = 0.04), but no interaction occurred between the group and time (F = 2.58, P = 0.06). Further comparison of the two groups at the same time point revealed that at T0, the average score of the intervention group was 0.07 points higher than that of the control group, but the difference was not significant (P = 0.93). At T1, the average score of the intervention group was lower than that of the control group, with a difference of 0.78 points (P = 0.37). The difference between the two groups gradually emerged over time at T2 and T3, with 2.34 points (P = 0.04) and 2.72 points (P = 0.01) respectively. In the intervention group, the mean within-group comparisons at different time points indicated that the mean score at T2 was significantly lower than at T0 (P = 0.001) and T1 (P = 0.004), and the mean score at T3 was significantly higher than at T2 (P = 0.04). In the control group, the mean score at T3 was significantly higher than at T0 (P = 0.03) and T2 (P = 0.007).
Variables Group T0 T1 T2 T3 Group Time Group×time F (P) F (P) F (P) EPDS Intervention group 8.70 ± 3.86 8.17 ± 4.16 6.03 ± 5.00*ab 7.58 ± 4.57*c 3.80
(0.050)4.86
(0.004)2.58
(0.060)Control group 8.63 ± 3.56 8.95 ± 3.73 8.37 ± 5.14 10.30 ± 5.15ac SAS Intervention group 41.24 ± 8.13 40.11 ± 6.35* 37.51 ± 5.83*a 39.46 ± 9.91 6.26
(0.010)3.06
(0.049)3.85
(0.020)Control group 41.44 ± 6.60 45.41 ± 6.99a 43.63 ± 10.64 43.46 ± 11.09 W-DEQ-
A/BIntervention group 72.19 ± 22.15 60.79 ± 18.53*a 62.00 ± 24.94*a N/A 8.01
(0.006)2.17
(0.100)4.29
(0.008)Control group 70.78 ± 18.04 75.73 ± 17.83 72.95 ± 22.49 N/A SWLS Intervention group 25.98 ± 3.98 28.35 ± 3.99*a N/A 25.58 ± 5.40*b 11.04
(0.001)7.72
(0.001)2.55
(0.080)Control group 24.78 ± 5.48 24.47 ± 4.04 N/A 22.47 ± 5.74ab FFMQ Intervention group 131.00 ± 12.16 133.22 ± 11.42* N/A 131.49 ± 15.75* 4.77
(0.03)1.68
(0.190)6.76
(0.002)Control group 129.77 ± 11.46 126.41 ± 12.16 N/A 122.79 ± 11.90a Note. T0 = before the intervention; T1 = after the intervention; T2 = 3 days after delivery; T3 = 42 days after delivery. FOC, Fear of children; EPDS, Edinburgh Postnatal Depression Scale; FFMQ, Five Facet Mindfulness Questionnaire; SAS, Self-Rating Anxiety Scale; SWLS, Satisfaction With Life Scale; W-DEQ-A/B, Delivery Expectancy/Experience Questionnaire. *A statistical difference was found between the intervention and control groups. aCompared with T0, a significant difference was noted. bCompared with T1, a significant difference was noted. cCompared with T2, a significant difference was noted. Table 3. Assessing the effects of depression, anxiety, FOC, satisfaction with life, and mindfulness using repeated-measures analysis of variance (mean ± SD)
Figure 4. Differences in fear of childbirth at T0, T1, and T3. W-DEQ, Delivery Expectancy/Experience Questionnaire.
Figure 5. Differences in satisfaction with life at T0, T1, and T3. SWLS, Satisfaction With Life Scale.
For anxiety, the overall results showed that the differences between the two groups were significant (F = 3.06, P = 0.049). The differences between different times were significant (F = 6.26, P = 0.01), and an interaction was found between the group and time (F = 3.85, P = 0.02). Further comparison of the two groups at the same time point revealed that the average score of the intervention group was 0.2 points lower than that of the control group at T0 but not statistically significant (P = 0.91). After the intervention, the difference between the two groups increased to 5.31 points (P = 0.001) at T1 and 6.12 points (P = 0.003) at T2; however, the difference between the two groups decreased to 4 points at T3 (P = 0.10). In the intervention group, the mean within-group comparisons at different time points indicated that the mean score at T2 was significantly lower than at T0 (P < 0.001), whereas in the control group, the mean score at T1 was significantly higher than at T0 (P = 0.03).
Figure 2. Differences in depression at T0, T1, T2, and T3. EPDS, Edinburgh Postnatal Depression Scale.
As regards FOC, the overall results showed that the difference between the groups was significant (F = 8.01, P = 0.006). The differences between different times were not significant (F = 2.17, P = 0.10), whereas an interaction occurred between group and time (F = 4.29, P = 0.008). Further comparison of the two groups at the same time point showed that the mean score for the intervention group was 1.41 points lower than that of the control group at T0 and was not significant (P = 0.75). The mean score for the intervention group was 14.95 points lower (P < 0.001) than that of the control group at T1; however, the gap between the two groups decreased at T2, and the mean score of the intervention group was 10.95 points lower (P = 0.04) than that of the control group. The mean comparison of scores within groups at different time points indicated that in the intervention group, the mean scores at T1 and T2 were significantly lower than those at T0 (P < 0.001, P = 0.002). The difference between the three time points in the control group was not statistically significant.
Regarding life satisfaction, the overall results showed that the difference between groups was significant (F = 11.04, P = 0.001). The differences between different times were significant (F = 7.72, P = 0.001), but no interaction occurred between group and time (F = 2.55, P = 0.08). Further comparison of the means of the two groups at the same time point showed that the average score of the intervention group at T0 was 1.2 points lower than that of the control group and was not significant (P = 0.27). After the intervention, the difference between the two groups increased to 3.86 points (P < 0.001). At T3, the difference between the two groups decreased to 3.1 points (P = 0.02). In the intervention group, the mean within-group comparisons at different time points indicated that the mean score at T1 was significantly higher than the mean score at T0 (P = 0.002), and the mean score at T3 was significantly higher than the mean score at T1 (P = 0.003). In the control group, the mean scores at T3 were significantly lower than those at T0 (P = 0.02) and T1 (P = 0.03).
For mindfulness, the overall results showed that the difference between the groups was significant (F = 4.77, P = 0.03). No significant difference was found at different times (F = 1.68, P = 0.19), but an interaction was noted between the group and time (F = 6.76, P = 0.002). Further comparison of the two groups at the same time point revealed that the mean score of the intervention group at T0 was 1.23 points higher than that of the control group and was not significant (P = 0.64). After the intervention, the difference between the two groups increased to 6.81 points (P = 0.01), and at T3, the difference increased to 8.7 points (P = 0.006). In the intervention group, the mean within-group comparisons at different time points indicated that the difference among the three time points was not significant. In the control group, the mean score at T3 was significantly lower than that at T0 (P = 0.001).
Benefits of Mindfulness Training on the Mental Health of Women During Pregnancy and Early Motherhood: A Randomized Controlled Trial
doi: 10.3967/bes2023.041
- Received Date: 2022-08-24
- Accepted Date: 2022-10-27
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Key words:
- Mindfulness /
- Depression /
- Anxiety /
- Fear of childbirth /
- Life satisfaction /
- Randomized controlled trial
Abstract:
The authors declare that there are no competing interests.
The study protocol was approved by the Ethics Review Committee of the National Center for Women and Children’s Health (Chinese Center for Disease Control and Prevention, Beijing, China; Approval no. FY2020-10) and conducted in accordance with the ethical principles regarding human experimentation of the Declaration of Helsinki. All participants submitted signed informed consent before inclusion in the study. We promise that they can terminate their participation for any reason at any time.
Trial registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR2000033149 Date of the first registration: 24/05/ 2020.
Citation: | WANG Shu Lei, SUN Meng Yun, HUANG Xing, ZHANG Da Ming, YANG Li, XU Tao, PAN Xiao Ping, ZHENG Rui Min. Benefits of Mindfulness Training on the Mental Health of Women During Pregnancy and Early Motherhood: A Randomized Controlled Trial[J]. Biomedical and Environmental Sciences, 2023, 36(4): 353-366. doi: 10.3967/bes2023.041 |