Depression, Postpartum Clinical Trial
Official title:
The Influence of Intensified Tactile Contact With a Newborn on the Emotional Transformation of Women After Physiological Delivery
NCT number | NCT05820958 |
Other study ID # | 8/2017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 10, 2021 |
Est. completion date | April 10, 2022 |
Verified date | April 2023 |
Source | The Jerzy Kukuczka Academy of Physical Education in Katowice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 43 |
Est. completion date | April 10, 2022 |
Est. primary completion date | February 14, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Poland | The Jerzy Kukuczka Academy of Physical Education | Katowice |
Lead Sponsor | Collaborator |
---|---|
The Jerzy Kukuczka Academy of Physical Education in Katowice |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Edinburgh Postnatal Depression Scale | 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. |
1) 3rd day after delivery; 2) within 13th week after delivery | |
Primary | Change in The Hospital Anxiety and Depression Scale | 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. |
1) 3rd day after delivery; 2) within 13th week after delivery | |
Primary | Change in Positive and Negative Affect Schedule questionnaire | 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. |
1) 3rd day after delivery; 2) within 13th week after delivery | |
Primary | Change in Parenting Sense of Competence questionnaire | 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. |
1) 3rd day after delivery; 2) within 13th week after delivery |
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