母婴运动计划对产后妇女身体成分、压力、疲劳和依恋的影响
母婴锻炼计划对产后妇女身体成分、压力、疲劳和依恋的影响：一项随机对照试验
The aim of this study is to explore the effectiveness of the intervention measures of the "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress, fatigue and parent-child attachment.
研究概览
详细说明
Background:
In Taiwan, more than 50% of maternal women will encounter obesity problems, because they have to take care of newborns, lack of proper exercise, and the traditional concept of confinement leads to excessive dietary supplementation, basal metabolic rate decline, and insufficient exercise. In addition to the physical changes after birth, women also face the change of the role of mothers. Caring for newborns is almost 24 hours on standby, gradually forming stress and fatigue. Stress may make postpartum women unable to perform the tasks of mothers. Makes postpartum women feel physiologically and psychologically uncomfortable. Both stress and fatigue have an adverse effect on their health, and are not conducive to parent-child attachment. However, early postpartum mothers and infants are almost inseparable. This period of attachment often affects infants' interpersonal relationships and emotions, if the relationship is not harmonious, may cause deviations in the baby's future behavior. Many studies have pointed out that moderate exercise can not only reduce the fatigue of postpartum women but also help to restore physical strength, help the recovery of organs and body, maintain physical health and weight management. However, busy with baby care and lack of continuous exercise often lead to postpartum women unable to reduce body weight. Therefore, this study hopes to develop a "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress and fatigue, and to improve the attachment relationship between parents and their infants.
Purposes:
Explore the effectiveness of the intervention measures of the "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress, fatigue and parent-child attachment.
Method:
In this study, a longitudinal and long-term follow-up randomized controlled trial study was adopted. The case was collected in a postpartum ward and an obstetrics and gynecology clinic of a medical center in the north Taiwan. The mothers who met the conditions for sample selection were selected as the research object. There are two different intervention modes (intervention group and control group), the intervention group is a Maternal-Infant Exercise Program, and the control group receives routine postpartum exercise nursing guidance. There are 50 people in each group. It is estimated that 100 healthy women with vagina postpartum will be collected. The questionnaires and physiological measurements are used to collect and aggregate the data. The main research variables are the Maternal-Infant Exercise Program, and the dependent variables are the postpartum women's body composition, stress, fatigue and parent-child attachment. The body composition of postpartum women is measured using a body fat meter, postpartum stress is measured using a Perceived Stress Scale(PSS), postpartum fatigue is measured using a Modified Fatigue Symptoms Checklist(MFSC), and the parent-child attachment relationship is measured using the Maternal Attachment Inventory(MAI). The two groups will collect data at one month, two months and three months after delivery, including body composition measurement and filling in each scale. The analysis method of the research data will use SPSS version 22.0 software, using chi-square test, independent sample t test , Pearson correlation, generalized estimation equations for discussion of results.
Result:
This study expects to understand the current status of postpartum women's body composition, stress, fatigue, and parent-child attachment. It is expected that parent-child exercise programs will improve postpartum women's body composition, as well as improve stress, fatigue, and enhance parent-child attachment.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Taipei、台湾
- TSGH
-
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Postpartum healthy women with vaginal delivery
- No obstetric complications
- Taiwanese, understand Chinese
- Agreed to participate in the research after the explanation, and agreed to receive four questionnaire surveys
- The baby's gestational weeks are more than 37 weeks and the birth weight is more than 2500 grams
- The baby has no complications or no congenital abnormalities
Exclusion Criteria:
- Four-degree laceration of the perineal wound
- A history of serious medical and surgical diseases cannot perform exercise
- Those who cannot cooperate with the implementation of the parent-child exercise program at least three days a week, 20-30 minutes each time
- The infant must be hospitalized for observation after being evaluated by a doctor and cannot be discharged
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Maternal-Infant Exercise Program
In the postpartum period, give the intervention group "Maternal-Infant Exercise Program" and encourage them to do exercise. The "Parent-Child Exercise Program" can be divided into three stages. Videos will be provided in each stage. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise. |
"Maternal-Infant Exercise Program" can be divided into three videos stages. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise. |
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安慰剂比较：Regular postpartum exercise guidance
Another group will receive "Regular postpartum exercise guidance". The guidance includes chest exercises, neck exercises, leg exercises, hip exercises, abdominal exercises, vagina contraction exercises, and uterine contraction exercises, starting from the third day after delivery to one month after delivery. The detail information will refer to the General Hospital of Tri-Services Provided the postpartum health education manual-postpartum exercise (p.8-10) |
"Maternal-Infant Exercise Program" can be divided into three videos stages. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body Composition- weight-T1
大体时间：T1-baseline
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This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg). |
T1-baseline
|
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Body Composition- weight-T2
大体时间：T2-one month later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg). |
T2-one month later
|
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Body Composition- weight-T3
大体时间：T3-two months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg). |
T3-two months later
|
|
Body Composition- weight-T4
大体时间：T4-three months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg). |
T4-three months later
|
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Body Composition- body mass index-T1
大体时间：T1-baseline
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2). |
T1-baseline
|
|
Body Composition- body mass index-T2
大体时间：T2-one month later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2). |
T2-one month later
|
|
Body Composition- body mass index-T3
大体时间：T3-two months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2). |
T3-two months later
|
|
Body Composition- body mass index-T4
大体时间：T4-three months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2). |
T4-three months later
|
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Body Composition- body fat-T1
大体时间：T1-baseline
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body fat percentage(%). |
T1-baseline
|
|
Body Composition- body fat-T2
大体时间：T2-one month later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body fat percentage(%). |
T2-one month later
|
|
Body Composition- body fat-T3
大体时间：T3-two months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body fat percentage(%). |
T3-two months later
|
|
Body Composition- body fat-T4
大体时间：T4-three months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body fat percentage(%). |
T4-three months later
|
|
Body Composition- body water-T1
大体时间：T1-baseline
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%). |
T1-baseline
|
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Body Composition- body water-T2
大体时间：T2-one month later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%). |
T2-one month later
|
|
Body Composition- body water-T3
大体时间：T3-two months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%). |
T3-two months later
|
|
Body Composition- body water-T4
大体时间：T4-three months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%). |
T4-three months later
|
|
Body Composition- muscle mass-T1
大体时间：T1-baseline
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg). |
T1-baseline
|
|
Body Composition- muscle mass-T2
大体时间：T2-one month later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg). |
T2-one month later
|
|
Body Composition- muscle mass-T3
大体时间：T3-two months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg). |
T3-two months later
|
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Body Composition- muscle mass-T4
大体时间：T4-three months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg). |
T4-three months later
|
|
Body Composition- bone mass-T1
大体时间：T1-baseline
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg). |
T1-baseline
|
|
Body Composition- bone mass-T2
大体时间：T2-one month later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg). |
T2-one month later
|
|
Body Composition- bone mass-T3
大体时间：T3-two months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg). |
T3-two months later
|
|
Body Composition- bone mass-T4
大体时间：T4-three months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg). |
T4-three months later
|
|
Body Composition- basal metabolic rate(BMR)-T1
大体时间：T1-baseline
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal). |
T1-baseline
|
|
Body Composition- basal metabolic rate(BMR)-T2
大体时间：T2-one month later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal). |
T2-one month later
|
|
Body Composition- basal metabolic rate(BMR)-T3
大体时间：T3-two months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal). |
T3-two months later
|
|
Body Composition- basal metabolic rate(BMR)-T4
大体时间：T4-three months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal). |
T4-three months later
|
|
Body Composition- body age-T1
大体时间：T1-baseline
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age). |
T1-baseline
|
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Body Composition- body age-T2
大体时间：T2-one month later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age). |
T2-one month later
|
|
Body Composition- body age-T3
大体时间：T3-two months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age). |
T3-two months later
|
|
Body Composition- body age-T4
大体时间：T4-three months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age). |
T4-three months later
|
|
Body Composition- Visceral fat-T1
大体时间：T1-baseline
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level). |
T1-baseline
|
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Body Composition- Visceral fat-T2
大体时间：T2-one month later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level). |
T2-one month later
|
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Body Composition- Visceral fat-T3
大体时间：T3-two months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level). |
T3-two months later
|
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Body Composition- Visceral fat-T4
大体时间：T4-three months later
|
This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level). |
T4-three months later
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postpartum stress-T1
大体时间：T1-baseline
|
The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress. |
T1-baseline
|
|
Postpartum stress-T2
大体时间：T2-one month later
|
The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress. |
T2-one month later
|
|
Postpartum stress-T3
大体时间：T3-two months later
|
The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress. |
T3-two months later
|
|
Postpartum stress-T4
大体时间：T4-three months later
|
The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress. |
T4-three months later
|
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Postpartum fatigue-T1
大体时间：T1-baseline
|
The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue. |
T1-baseline
|
|
Postpartum fatigue-T2
大体时间：T2-one month later
|
The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue. |
T2-one month later
|
|
Postpartum fatigue-T3
大体时间：T3-two months later
|
The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue. |
T3-two months later
|
|
Postpartum fatigue-T4
大体时间：T4-three months later
|
The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue. |
T4-three months later
|
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Attachment-T1
大体时间：T1-baseline
|
The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment. |
T1-baseline
|
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Attachment-T2
大体时间：T2-one month later
|
The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment. |
T2-one month later
|
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Attachment-T3
大体时间：T3-two months later
|
The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment. |
T3-two months later
|
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Attachment-T4
大体时间：T4-three months later
|
The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment. |
T4-three months later
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.