Evidence map›Paper›PMID 38858743›Full record

ArticleBMC psychology2024

Promoting sleep health during pregnancy for enhancing women's health: a longitudinal randomized controlled trial combining biological, physiological and psychological measures, Maternal Outcome after THERapy for Sleep (MOTHERS).

Debora Meneo, Elisabetta Baldi, Silvia Cerolini, Sara Curati, Stefano Bastianini, Chiara Berteotti, Giuliana Simonazzi, Mauro Manconi, Giovanna Zoccoli, Paola De Bartolo and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06379074 (Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06379074 narecruitingnot on this map

Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health: A Translational, Longitudinal and Clinical Study. Maternal Outcome After THERapy for Sleep (MOTHERS)

TypeinterventionalSponsorUniversity of Rome G. MarconiRan2024 to 2026Enrolled114ConditionsPostpartum Depression, Insomnia, StressArmsImproving sleep health and resilience during pregnancy, Information on pregnancy-related issues
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Debora MeneoDepartment of Human Sciences, Guglielmo Marconi University, Rome, Italy.
Elisabetta BaldiDepartment of Human Sciences, Guglielmo Marconi University, Rome, Italy.
Silvia CeroliniDepartment of Human Sciences, Guglielmo Marconi University, Rome, Italy.
Sara CuratiDepartment of Human Sciences, Guglielmo Marconi University, Rome, Italy.
Stefano BastianiniDepartment of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
Chiara BerteottiDepartment of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
Giuliana SimonazziDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Mauro ManconiSleep Medicine Unit, Faculty of Biomedical Sciences, Neurocenter of the Southern Switzerland, Regional Hospital of Lugano, Università Della Svizzera Italiana, Lugano, Switzerland.
Giovanna ZoccoliDepartment of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
Paola De BartoloDepartment of Human Sciences, Guglielmo Marconi University, Rome, Italy.
Francesca GelfoDepartment of Human Sciences, Guglielmo Marconi University, Rome, Italy.
Viviana Lo MartireDepartment of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
Chiara BaglioniDepartment of Human Sciences, Guglielmo Marconi University, Rome, Italy. c.baglioni@unimarconi.it.

Funding

Ministero dell'Università e della Ricerca 2022PMFMSENational Recovery and Resilience Plan - Next Generation Europe CUP C85C23002540001; scholarship unique ID 7848
6 · The paper itself

Abstract

backgroundSleep is vital for maintaining individuals' physical and mental health and is particularly challenged during pregnancy. More than 70% of women during the gestational period report insomnia symptoms. Sleep dysfunction in the peripartum increases the risk for a cascade of negative health outcomes during late pregnancy, birth, and postpartum. While psychological interventions are considered the first line treatment for sleep difficulties, they are still scarcely offered during pregnancy and there is a lack of longitudinal research combining psychological and physiological indices.

methodsThe present protocol outlines a randomized controlled trial aimed at testing the long-term effectiveness of an automatized digitalized psychoeducational intervention for insomnia for expectant mothers complaining insomnia symptoms without comorbidity. Outcomes include physiological, hormonal, and subjective indices of maternal psychopathology, stress, and emotional processes, and sleep and wellbeing of the family system. The trial is part of a longitudinal study evaluating expectant mothers from early pregnancy (within the 15th gestational week) to 6-months postpartum through 6 observational phases: baseline (BSL), 6- and 12-weeks from BSL (FU1-FU2), 2-to-4 weeks after delivery (FU3), and 3- and 6-months after delivery (FU4-5). We plan to recruit 38 women without sleep difficulties (Group A) and 76 women with sleep difficulties (Group B). Group B will be randomly assigned to digital psychological control intervention (B1) or experimental psychoeducational intervention targeting insomnia (B2). At 3 time points, an ecological-momentary-assessment (EMA) design will be used to collect data on sleep and emotions (diaries), sleep-wake parameters (actigraphy) and stress reactivity (salivary cortisol). We will also test the DNA methylation of genes involved in the stress response as biomarkers of prenatal poor sleep. Information on partner's insomnia symptoms and new-borns' sleep will be collected at each stage. DISCUSSION: The proposed protocol aims at testing an easily accessible evidence-based psychoeducational intervention for expectant mothers to help them improving sleep, health, and wellbeing in the peripartum. The results could improve the understanding and management of sleep difficulties and peripartum depression.

trial registrationThe study protocol has been registered on 22 April 2024 with ClinicalTrials.gov Protocol Registration and Results System (PRS), ID: NCT06379074. PROTOCOL VERSION: April 23, 2024.

Indexed as

Sleep Initiation and Maintenance DisordersAdultFemaleHumansLongitudinal StudiesMothersPostpartum PeriodPregnancyPregnancy ComplicationsRandomized Controlled Trials as TopicWomen's HealthActigraphyCortisolEmotional processesInsomniaPerinatal sleep qualityPost-partumPregnancySleep diaryStress

Identifiers

PMID38858743
PMCPMC11165884

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.