MYND&CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza
NCT ID: NCT03839004
Last Updated: 2019-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2019-01-08
2021-01-31
Brief Summary
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A randomized non farmacological monocentric trial.
400 women with single spontaneous pregnancies are randomized.
200 recieve standardized traditional obstetrical care
200 recieve nutritional advice, osteopathic treatment, yoga classes, mindfulness classes and coaching as well as regular obstetrical care.
We evaluate the psychological status at recruitment, at the end of pregnancy and 40 days after birth.
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Detailed Description
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This innovative model aims to the gold standard of a "positive pregnancy", which supports both the somatic and psychological component of the mother-newborn unit, and thus organically and proactively prevents the main issues arising during pregnancy and delivery due to unhealthy lifestyles.
A team of experts will take comprehensive care of the mother, first by means of an accurate evaluation of her nutritional profile, and then of her biomechanic (osteo-skeletal) state.
Then, the experts will lead an "academic" path, which will initiate a development of her biochemistry (through nutrition), respiration (through yoga), physical wellbeing (through osteopathy and yoga); and strengthen her sense of self, removing her self-doubt (through mindfulness and yoga).
The women will be supported up until childbirth, so as to attempt to prevent the main complications of pregnancy and of delivery.
This model does not aim to substitute the allopathic one which is currently in place (ultrasounds, ob-gyn appointments, tests, etc.), but to enhance its nature in a more effectively THERAPEUTIC manner, increasing the mother-newborn unit's potential of health.
In summary:
* Weekly mindfulness meet-ups
* Weekly yoga meet-ups
* Nutritional screening and further check-ups, if needed
* Osteopathic screening
* Five motivational meetings with a coach
* Four obstetrical appointments
* Obstetrical screening and check-ups up until childbirth
The team in charge of the project is made up of gynaecologists, midwives, psychologists, osteopaths, nutritionists and yoga teachers, who all collaborate on a regular basis with the Clinica Mangiagalli.
The project is offered to women free of charge.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Intervention group
200 woman with single spontaneous pregnancies who recieve, as well as traditional obstetrical care, yoga classes, myndfulness classes, coaching, nutrition counselling and osteopathic treatment
Integrated approach to pregnancy
Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy
Controls
200 woman with single spontaneous pregnancies recieving traditional obstetrical care
No interventions assigned to this group
Interventions
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Integrated approach to pregnancy
Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy
Eligibility Criteria
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Inclusion Criteria
* spontaneous pregnancies
* no maternal medical conditions
* no language barrier
Exclusion Criteria
* age \<18 or \<45
* ivf
* language barrier
* multiple pregnancies
18 Years
45 Years
FEMALE
Yes
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Principal Investigators
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Niccolò Giovannini, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Clinica Mangiagalli
Locations
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Fondazione IRCCS Ca' Granda
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Giovannini N, Cetera GE, Ercolino C, Miozzo MR, Parazzini F, Ferrazzi EM, Manzotti A, Colaceci S. MYNd&CO (Mindfulness, Yoga, Nutrition, development & Coaching, and Osteopathy) randomized controlled trial for a positive psychophysical experience in pregnancy and after birth: a study protocol. Acta Biomed. 2021 Jul 29;92(S2):e2021032. doi: 10.23750/abm.v92iS2.11259.
Other Identifiers
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MYND&CO
Identifier Type: -
Identifier Source: org_study_id
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