Effectiveness of photobiomodulation therapy on pain intensity in postpartum women with nipple or perineal trauma: protocol for a multicentre, double-blinded, parallel-group, randomised controlled trial

Introduction
Photobiomodulation (PBM) using low-level laser can affect tissue repair mechanisms and seems promising in reducing pain intensity. However, few studies support the effectiveness of PBM on postpartum period complications, such as nipple and/or perineal trauma and pain, probably due to the low doses used. The primary objective of this study is to analyse the effectiveness of PBM on pain intensity in the nipple and perineal trauma in women in the immediate postpartum period. Secondary objectives are to evaluate the effect on tissue healing and the women’s satisfaction.

Methods and analysis
A double-blind, multicentre, parallel-group, randomised controlled trial will be performed in two public referral maternity hospitals in Brazil with 120 participants, divided into two arms: 60 participants in the nipple trauma arm and 60 participants in the perineal trauma arm. Participants will be women in the immediate postpartum period, who present with nipple trauma or perineal trauma and report pain intensity greater than or equal to 4 points on the Numerical Rating Scale for Pain. Block randomisation will be performed, followed by blinding allocation. In the experimental group, one application of PBM will be performed between 6 hours and 36 hours after birth. For the sham group, the simulation will be carried out without triggering energy. Both participants and the research evaluator will be blinded to the allocation group. Intention-to-treat method and the between-group and within-group outcome measures analysis will be performed.

Ethics and dissemination
This research protocol was approved by the Research Ethics Committees of the University of Campinas, Brazil, and of the School Maternity Assis Chateaubriand, Brazil (numbers CAAE: 59400922.1.1001.5404; 59400922.1.3001.5050). Participants will be required to sign the informed consent form to participate. Results will be disseminated to the health science community.

Trial registration number
Brazilian Registry of Clinical Trials (RBR-2qm8jrp).

Leggi
Dicembre 2023

Effect of adverse perinatal outcomes on postpartum maternal mental health in low-income and middle-income countries: a protocol for systematic review

Introduction
More than three-fourths of adverse perinatal outcomes (preterm, small for gestational age, low birth weight, congenital anomalies, stillbirth and neonatal death) occur in low-income and middle-income countries. These adverse perinatal outcomes can have both short-term and long-term consequences on maternal mental health. Even though there are few empirical studies on the effect of perinatal loss on maternal mental illness, comprehensive information on the impact of adverse perinatal outcomes in resource-limited settings is scarce. Therefore, we aim to systematically review and synthesise evidence on the effect of adverse perinatal outcomes on maternal mental health.

Methods and analysis
The primary outcome of our review will be postpartum maternal mental illness (anxiety, depression, post-traumatic stress disorder and postpartum psychosis) following adverse perinatal outcomes. All peer-reviewed primary studies published in English will be retrieved from databases: PubMed, MEDLINE, CINAHL Ultimate (EBSCO), PsycINFO, Embase, Scopus and Global Health through the three main searching terms—adverse perinatal outcomes, maternal mental illness and settings, with a variant of subject headings and keywords. We will follow the Joanna Briggs Institute critical appraisal checklist to assess the quality of the studies we are including. The review findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 statement. Estimate-based meta-analysis will be performed. We will assess heterogeneity between studies using the I2 statistics and publication bias will be checked using funnel plots and Egger’s test. A subgroup analysis will be conducted to explore potential sources of heterogeneity (if available). Finally, the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation approach.

Ethics and dissemination
Since this systematic review does not involve human participants, ethical approval is not required. The review will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number
CRD42023405980.

Leggi
Dicembre 2023

Abstract 15628: Digital Health Interventions for the Optimization of Postpartum Cardiovascular Health: A Systematic Review

Circulation, Volume 148, Issue Suppl_1, Page A15628-A15628, November 6, 2023. Introduction:Insufficient maternal care in the postpartum period (PP) has resulted in significant maternal morbidity and mortality in the U.S., most commonly due to cardiovascular (CV) disease. Digital health technologies have been proposed as a potential solution to eliminate barriers to maternal CV care. In this context we performed a systematic review to determine the benefit of digital health interventions designed to improve postpartum CV health.Methods:We conducted a systematic review of PubMed/MEDLINE, EMBASE, CINAHL, Web of Science and the Cochrane Library. We included studies if the study population included PP women, and an intervention that involved digital or mobile health (including wearable devices, telemedicine, or remote monitoring). We only included studies that measured an outcome related to CV health. Two independent reviewers screened all studies and a third independent reviewer resolved any conflicts.Results:Our initial search identified 1448 studies. After removal of 143 duplicates, 1305 abstracts were screened of which 51 full studies were assessed for eligibility. Of these, 17 met inclusion/exclusion criteria. Studies were categorized into 3 broad CV outcomes: blood pressure (BP), physical activity (PA), and diet/weight loss. The majority of remote BP monitoring programs paired with telemonitoring (N=5 studies) were successful in optimizing BP, and increasing likelihood of BP measurement within 10 days PP. Interventions aimed at increasing PP physical activity included mobile applications, text-based coaching, and wearable devices such as pedometer and FitBit (N=9 studies). Just over half of these studies showed no change in PA, while the other half showed modest benefit at increasing daily or weekly PA. Weight loss interventions included smartphone applications, interactive websites, or text-based coaching (N=6 studies). Most of these studies showed a modest benefit in terms of lowered caloric intake and/or weight loss up to 1 year PP.Conclusions:The majority of studies we reviewed found that digital health interventions such as mobile health, telemonitoring and wearable devices were effective at improving postpartum CV health in the postpartum period.

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Novembre 2023