The Influence of Intensified Tactile Contact With a Newborn on the Emotional Transformation of Women After Physiological Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in Edinburgh Postnatal Depression Scale
研究概览
简要总结
The goal of this clinical trial is to test the influence of intensified tactile contact between mother and newborn on the direction of the emotional transformation of the mother from the physiological, undisturbed delivery to 12 weeks postpartum. The participants will deliver intensified tactile stimulation to their newborns in the form of Shantali massage at least 2 times a day. Researchers will compare the results obtained in the intervention group to the control group in which participants voluntarily did not agree to introduce more intensive tactile contact with the child. The main question the study aims to answer is: Is the direction of the mother's emotional transformation different after the intensification of tactile contact with the newborn in comparison to the control group?
详细描述
Postpartum blues, depression, and psychosis are frequent, burdensome disorders acknowledged by WHO. Investigations into their mechanisms, possible causes, and treatments are strongly needed.
OVERALL RESEARCH QUESTION Is the direction of the mother's emotional transformation different after the intensification of tactile contact with the newborn in comparison to the control group? DESIGN In the study, the non-randomized quasi-experimental design was applied. The dependent variables were: the level of emotions in the designated 'negative' domain (depression, anxiety, negative affects); the level of emotions in the designated 'positive' domain (satisfaction, sense of effectiveness, positive affects). Their values were measured with the use of four standardized, self-reported questionnaires two times, i.e. before and after the 12-week observation period.
PARTICIPANTS The experimental group was selected from the local population of pregnant women who volunteered to provide experimental intervention to their children after birth. Purposive sampling was utilized based on specified eligibility criteria. The intervention (see below) started on the 3rd day after birth and lasted until the end of the 12th week postpartum. Finally, 43 participants completed the procedure.
The control group consisted of the participants from our previous, observational study matched by age, body mass, and height to the participants of the experimental group. These women consciously did not agree to apply the experimental intervention to their children during the observation period.
All participants attended lectures and practical training in a local childbirth school. The volume of their education was similar, except for the training of experimental intervention (5h in total) which was additionally introduced in the participants of the experimental group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators were blinded to the results in that way that questionnaires serving as outcome measures were filled up online and results were recorded in the online database. This process was fully automatic. The investigators were unaware of the results until the base was 'opened' after the completion of the study.
After the completion of the study, the control group was selected from participants of our previous, observational study based on a non-random, matched sampling method. this procedure was completed by one of the investigators. Then, the data were sent to the outcomes assessor with the names of the groups coded. The assessor was unaware of the roles of the two groups in the study.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •first physiological delivery;
- •no previous miscarriages;
- •normal course of pregnancy;
- •normal fetal development confirmed by prenatal ultrasound examination;
- •consent to the intervention in the form of intensifying tactile contact with the child during the observation period.
排除标准
- •poor health of the child after birth, Apgar score< 8 points;
- •complicated physiological delivery with accompanying poor physical condition of the mother after delivery (deep vein thrombosis, pulmonary embolism, postpartum hemorrhage, inflammation);
- •deterioration of the child's health condition preventing contact between mother and child (child's illness, incubation of the child);
- •deterioration of the mother's health during the observation period;
- •deterioration of the mother's emotional state during the observation due to external factors, such as sudden deterioration of the financial situation, traumatic family events (death, severe illnesses, accidents, etc.), significant deterioration of partnership relations between the child's parents, emotionally burdensome legal problems.
- •lack of proper compliance with intervention procedures in the form of intensifying tactile contact with the child, the number of procedures performed <50% of the recommended number.
结局指标
主要结局
Change in Edinburgh Postnatal Depression Scale
时间窗: 1) 3rd day after delivery; 2) within 13th week after delivery
Psychological questionnaire used to evaluate the change of postpartum depression level. Minimal score - 0 points; maximal score - 30 points. A higher score indicates a higher level of postpartum depression (i.e. higher score = worse). The questionnaire was presented to respondents in an online form.
Change in Parenting Sense of Competence questionnaire
时间窗: 1) 3rd day after delivery; 2) within 13th week after delivery
Psychological questionnaire used to evaluate the change in the level of parental competence of the respondent The questionnaire consists of two subscales. Subscale 'satisfaction': Minimal score - 0 points; maximal score - 54 points. A higher score indicates a higher level of parental satisfaction (i.e. higher score = better). Subscale 'effectiveness': Minimal score - 0 points; maximal score - 48 points. A higher score indicates a higher level of parental effectiveness (i.e. higher score = better). The questionnaire was presented to respondents in an online form.
Change in The Hospital Anxiety and Depression Scale
时间窗: 1) 3rd day after delivery; 2) within 13th week after delivery
Psychological questionnaire used to evaluate the change in the general level of depression and anxiety associated with the hospital stay. Minimal score - 0 points; maximal score - 21 points. A higher score indicates a higher level of depression and anxiety (i.e. higher score = worse). The questionnaire was presented to respondents in an online form.
Change in Positive and Negative Affect Schedule questionnaire
时间窗: 1) 3rd day after delivery; 2) within 13th week after delivery
Psychological questionnaire used to evaluate the change in the levels of positive and negative affective behavior occurring parallelly in the same person within this same time frame The questionnaire consists of two subscales. Subscale 'positive affects': Minimal score - 0 points; maximal score - 50 points. A higher score indicates a higher level of positive affects (i.e. higher score = better). Subscale 'negative affects': Minimal score - 0 points; maximal score - 50 points. A higher score indicates a higher level of negative affects (i.e. higher score = worse). The questionnaire was presented to respondents in an online form.
次要结局
未报告次要终点
研究者
Rafał Gnat
MSC, associate professor
The Jerzy Kukuczka Academy of Physical Education in Katowice