CHU Amiens Picardie
Amiens, Picardie, 80054, France
Location status: Recruiting
NCT Number: NCT07525830
The quality of sleep in maternity wards is crucial for the mental and physical health of the mother, as well as for the development of secure mother to infant bonding. The introduction of "co-dodo" cribs, although scarcely studied, may influence sleep quality in both the mother and the newborn infant. Objective : This study aims at evaluating the impact of a co-dodo crib on the sleep quality of the newborn infant, her mother and the mother-infant bonding, compared to a control group with mother using a standard crib.
This observational, randomized, controlled, multicenter study will include adult mother, breastfeeding and hospitalized in maternity wards after full-term delivery (≥ 37 weeks of gestation). Participant will be randomly assigned in a 1:1 ratio to receive either a co-dodo crib or a standard crib for their newborn infant during their maternity STAI-Y. Actigraphic data will be used for non-invasive sleep assessment in both the newborn infant and the mother. Validated self-reported questionnaires will evaluate maternal stress, sleep quality, post-partum depression risk and mother-infant bonding. • Hypothesis : We hypothesize that using a co-dodo crib compared to a standard crib may improve the newborn and mother sleep quality, decrease the mother stress and enhance the mother to infant bonding.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Amiens, Picardie, 80054, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Secondary exclusion criteria:
Patients and their newborns will be randomized into two groups: standard cradle or co-sleeping cradle.
Once the cradle has been allocated, they will be given two actimeters: one for the mother (a bracelet worn on the wrist) and a second for the newborn (a bracelet worn on the ankle above the pyjamas).
Recording of sleep quality data will begin as soon as the actimeters are worn. At the end of their stay in the maternity ward (3 days ± 2 days), the actimeters will be returned to us and the data downloaded into the dedicated software.
During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills
Time frame: 4 months
impact of co-sleeping on the total sleep time of breastfeeding mothers, compared with a control group in which the breastfeeding mothers use a standard cradle.
Time frame: 4 months
Evaluate the effect of co-sleeping on total sleep time of newborn
Time frame: 4 months
sleep quality of newborn is evaluated by total sleep time
Time frame: 4 months
Sleep quality is evaluated with total sleep time
Time frame: 4 months
During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills.
Time frame: 4 months
Time frame: 4 months
Observe changes in the newborn's sleeping pattern once he/she returns home;
Time frame: 4 months
changes in the quality of sleep experienced by the mother once she has returned home during the child's first months of life
Time frame: 4 months
complications related to breastfeeding that could have an impact on the mother's sleep quality.
Time frame: 4 months
sleep quality of and breastfeeding mother is evaluated with total sleep time
Time frame: 4 months
sleep quality of newborn is evaluated with frequency of nocturnal awakenings
Time frame: 4 months
sleep quality of newborn is evaluated with duration of nocturnal awakenings
Time frame: 4 months
sleep quality of newborn is evaluated with sleep latency
Time frame: 4 months
sleep quality of newborn is evaluated with duration of sleep phases.
Time frame: 4 months
Sleep quality is evaluated with frequency of nocturnal awakenings
Time frame: 4 months
Sleep quality is evaluated with duration of nocturnal awakenings
Time frame: 4 months
Sleep quality is evaluated with sleep latency
Time frame: 4 months
Sleep quality is evaluated with duration of sleep phases.
Time frame: 4 months
sleep quality of breastfeeding mother is evaluated with frequency of nocturnal awakenings
Time frame: 4 months
sleep quality of breastfeeding mother is evaluated with duration of nocturnal awakenings
Time frame: 4 months
sleep quality of breastfeeding mother is evaluated with sleep latency
Time frame: 4 months
sleep quality of breastfeeding mother is evaluated with duration of sleep phases.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire, Amiens
Other
Acronym: COSMOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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