The systematic review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on August 2021, Reg ID: CRD42021272323. We followed the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-analysis) guidelines to describe this protocol. (Supplementary data file 1).
Types of studies
All types of hospital-based observational studies, cross-sectional surveys, descriptive studies, qualitative studies, and mixed-method studies will be included in the review.
Time: English articles published from January 2000 to December 2021 with full text will be included.
All experimental studies, studies not conducted in India, studies on the stress level of family members (other than parents) of high-risk neonates admitted into NICU will be excluded. Study designs such as case reports, letters, editorials, case-control, cohort studies, and narrative reviews will be excluded. Studies wherein neonates were admitted to NICU for 24 hours of observation will not be eligible. Studies of mothers with a history of diagnosed prenatal and postnatal psychiatric illness will be excluded as well.
Type of participants
This review will include high-risk neonates admitted to NICU & their parents irrespective of the father’s age, maternal age, gestational age, type of delivery, neonatal medical condition, gender, and neonatal birth weight.
Type of outcome
Stress and stressors experienced by the parents of high-risk neonates admitted to NICU.
Stress and stressors experienced by the high-risk neonates admitted to NICU.
Definition of terms
Stress: Any intrinsic or extrinsic feeling of emotional or physical tension that evokes a biological response is known as stress .
Stressors: A chemical or biological element, emotional consequences, environmental condition or an external stimulus that causes stress .
A comprehensive search would be conducted in Global databases like CINAHL via EBSCO host, MEDLINE via PubMed, EMBASE, SCOPUS, Ovid, Web of Science, ProQuest Medical Library, Microsoft academic, and DOAJ. Indian databases like Indian Citation Index, J-Gate, and Neonatal Database (JCDR) by utilizing the stated search keywords: Mother*, Caregiver, Caregiver*, Parent*, Female parent, Preterm baby, Low birth weight babie*, Newborn*, neonat*, Premature infant*, High-risk neonat*, high-risk newborn, “Maternal Stress”, “Neonatal stress”, Stress, Psychological stress, Mental stress, Depression, Stressors, Anxiety, Fear, Tension, “Neonatal Intensive Care Unit”, NICU, “Neonatal Care Unit”, “Neonatal critical care unit”, “Observational studies”, “Cross-sectional studies”, “Descriptive survey”, “qualitative studies”, “mixed method studies”. (Appendix 1).
Searching for other resources
Online hand searching will be done on Indian websites like institutional websites, women and child welfare websites, NGOs, repositories, registries, search engines, pediatric journals, and gray literature. All primary studies reference lists will be scrutinized for additional studies. For data management, identified records will be exported to endnote X7..
Selection of studies
Two review authors (initials SN, TP) will screen each study title and abstract the remaining search results independently. The studies will be coded to be retrieved (potentially eligible or ineligible /unclear) or not to be retrieved. All full-text articles which are eligible for inclusion will be retrieved, independently screened, and reasons recorded to exclude ineligible studies. If there is a disagreement, it will be resolved by mutual conversation or, if necessary, consultation with the third review author. (BSN). (Supplementary data file).
If numerous reports of the same study are identified, the reviewers will identify and exclude the duplicates, as well as aggregate multiple reports of the same study. The JBI critical appraisal tool will be utilized to assess the quality of studies. We will report in the PRISMA flowchart format outlining with illustrations on our process of selection and choice. (Fig.1)
Data extraction and management (selection & coding)
A standard form will be developed and utilized for extracting the data. Before its use in the review, this data extraction form will be further piloted and thoroughly revised according to the need.
In areas where information or any data is found to be lost or lacking, each exertion will be made to get in touch with the author, or the request will be made to the author to provide added data or information. After the independent review of data extraction by the two reviewers, it will be further designated to a third reviewer for other erratic resolutions of any inconsistencies.
Assessment of quality of the studies
The studies' quality will be independently appraised by two review authors, aiming to resolve contradictions by conferencing with the third author (30)]
We will use the Joanna Briggs Institute (JBI) Critical Appraisal Checklist to identify the risk of bias and selection bias (High-risk neonates admitted in NICU and their parents).
Critical Appraisal Skills Program (CASP) checklist will be utilized to evaluate the study quality .
Mixed methods studies
We will use the Mixed Methods Appraisal Tool (MMAT) to identify the bias risk (32)] (33)].
We will assess and report whether the investigators adequately or entirely address all the outcomes.
Reporting of a selective outcome
We will identify studies suggestive of reporting specific outcomes selectively.
Additional sources for bias
We would further recognize and notify that the study is clear from all the other drawbacks that tend to be a possibility of more significant risk bias.
Dealing with missing data
Researchers from the original studies will be contacted to confirm significant research characteristics and, where feasible, collect missing numerical outcome data (e.g., when a study is identified as an abstract only). If this approach is impossible and the missing data is believed to produce significant bias, the article will be removed from consideration.
All included considerable studies will be presented in a descriptive and tabular form, summarizing critical features, elements concerning design areas, assessment methods, a key indicator of risk of bias in every specific study, and study outcomes.
Subgroup analyses and investigation of heterogeneity
Meta-analyses will be undertaken if there is enough homogeneity in study design and study subjects among the selected studies. If possible, sub-group analysis will be carried out based on the study's period and location.
Assessment of bias conducting the systematic review
The review will be conducted based on this protocol, and any deviations from it will be justified in a distinct section of the review.