Assessment and diagnosis of insomnia for clinical and research practice: a scoping review protocol

Insomnia is one of the leading sleep disorders, affecting different age groups, influencing individual’s ability to perform daily life activities, and ultimately diminishing their quality of life. This scoping review aims to identify instruments applied for the diagnosis of insomnia in clinical and research settings to support the nursing process and the decision-making. This review is based on the scope review framework proposed by Peters et al. (2020). The research strategy outlined aims to find studies published in the CINAHL (EBSCOhost) electronic database, Scopus, PubMed and WoS Portals. Grey literature will be accessed through free search via Google and Google Scholar, CAPES Thesis Repository, the Organizations Sleep Brazilian Association and World Sleep Society. This scope review is expected to assist nurses in the clinical reasoning process for identifying Nursing Diagnosis “insomnia”. In addition to the contribution to the research area, a proposal to include an insomnia assessment instrument(s) as diagnostic indicators in the NANDA-I taxonomy is planned. It should be noted the low volume of publications of scope review protocols. This protocol has been registered with the Open Science Framework under DOI 10.17605/OSF.IO/8MRPG.


Introduction
Insomnia is one of the major sleep disorders, observed across different age groups (Alqudah et al., 2019;Altena et al., 2017). The term sleep disorder refers to conditions affecting the quality, timing or duration of sleep and influence a person's ability to perform routine activities properly. These disorders can contribute to other medical problems and some can also be symptoms of underlying mental health problems (Duncan, & Sheppard, 2019;Grima, Bei, & Mansfield, 2019;Zdanowicz et al, 2020).
The 3 rd edition of the International Classification of Sleep Disorders (ICSD-III) (2014) revised by the American Academy of Sleep Medicine (AASM), in which is divided into seven major categories, defines insomnia as difficulty in initiating or maintaining sleep; and a decrease in its duration and quality, which occurs despite the opportunity and adequate circumstances for sleeping, associated with dysfunctions during the day. Insomnia is subdivided into Chronic Insomnia Disorder (that occur at least three times a week and persist for the last 3 months), Short-Term Insomnia Disorder (insomnia that have been experienced within three months), Other Insomnia Disorder (difficulty in initiating or maintaining sleep that does not meet the criteria of chronic insomnia or short-term insomnia disorder).
The American Psychiatric Association (APA) (2013) uses the term chronic insomnia disorder (code F51.01 by the International Disease Code-10-CM), in the Sleep-Wake Disorders group, according to the Diagnostic and Statistical Manual of Mental Disorders, 5 th Edition, . The diagnostic criteria are: difficulty initiating or maintaining sleep, the latter characterized by frequent awakenings or difficulty in returning to sleep after awakening. It is also characterized by waking up before the usual time with an inability to return to sleep, emphasizing the duration of symptoms and number of episodes.
Insomniacs often experience tiredness or fatigue upon awakening, inability to concentrate and frequent daytime naps, resulting in poor quality of life (Bollu & Kaur, 2019;Chevance et al., 2020). Depressive symptoms, depression diagnoses (Difrancesco et al., 2019;Silva et al, 2020), and bidirectional relationship between anxiety and mood regulation are observed in patients with insomnia (Tubbs et al, 2020). Futhermore, a potential genetic correlation between insomnia and coronary artery disease has been reported (Lane et al., 2019). These findings highlight the importance of investigating insomnia with accurate assessment tools and instruments.
Insomnia results in significant distress in different areas of the individual's life, such as academic (Xie et al., 2017) and social (Bruni et al., 2017), and can last for more than 2 years (Wilson et al., 2019). It can be classified as initial (difficulty starting the sleep period), intermediate (waking up during the night and having difficulty falling asleep), and terminal (unlike the previous one, waking up is very early) (APA, 2013). In the elderly, insomnia is the most significant sleep disorder and its natural reduction in sleep duration can generate anxiety and worsen insomnia symptoms (Patel et al, 2018;Gulia & Kumar, 2018). Therefore, the participation of the multidisciplinary team in the evaluation process is essential (Molassiotis et al., 2020).
The 11 th edition of the NANDA-I Taxonomy (2018-2020) propose the Nursing Diagnosis (ND) "Insomnia" (code 00095) as: "A disruption in amount and quality of sleep that impairs functioning". One of the diagnostic indicators that constitute this ND is Defining Characteristics, that include: alteration in affect; alteration in concentration; alteration in mood; alteration in sleep pattern; compromised health status; decrease in quality of life; difficulty initiating sleep; difficulty maintaining sleep state; dissatisfaction with sleep; early awakening; increase in absenteeism; increase in accidents; insufficient energy; nonrestorative sleep pattern; sleep disturbance producing next-day consequences. The other diagnostic indicators are: (Herdman & Kamitsuru, 2017, p. 253).

Related Factors and Associated Conditions
Diagnostic indicators assist in the adequate assessment, documentation and clinical reasoning that support the diagnostic judgment. Thus, nurses must distinguish the diagnostic indicators to classify the ND "insomnia" and develop the care plan. Besides, diagnostic indicators promote better planning of expected outcomes and interventions that meet the needs of the individual (Brinati et al., 2020;Passarelles et al., 2020).
The use of scales and instruments can assist nurses in diagnostic reasoning in clinical practice (Huang et al, 2020;Schroeder et al., 2021) evaluate response to treatments (Lam & Macina, 2017), and promote safe evidence-based assistance in different care environments (Vieira et al., 2020). Instruments and scales can be applied by nurses in different contexts and groups, as in the assessment of sleep patterns in health students (Garcia et al., 2019), pathologies associated with overweight (Fusco et al., 2020), assessment of quality of life in oncological individuals (Salvetti et al., 2020) and evaluation of the health of nurses working in psychiatric institutions (Sousa et al., 2020).
Instruments are useful in the assessment of sleep quality, identification of the severity of disorders and diagnosis of insomnia (Riemann et al., 2017). Self-report instruments are usefull to assess sleep quality and other sleep patterns (Rudman et al, 2020), assess the severity of sleep disorders, as insomnia, in different populations and settings (Adell et al., 2020). Besides, these reliable tools are low-cost, fast and user-friendly (Costa et al., 2020).
In view of these facts, and given the complexity of the characteristics of insomnia, the goal of this scoping review protocol is to identify instruments for assessment and diagnosis of insomnia for nurses. Research, Society and Development, v. 10, n. 4, e2810413736, 2021 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v10i4.13736

Methodology
Also named as "scoping studies" and "mapping studies" (Morris et al., 2016), the scoping review protocols assist in structuring research and selecting studies (Silveira et al., 2020). Some objectives of scoping review are mapping primary studies or review studies, seeking to synthesize the evidence to answer questions related to a specific phenomenon or set of phenomena (Peterson et al., 2017), resume and disseminate findings researches, identify research gaps in the existing literature (Morris et al., 2016), guide health care practice and decision-making in health (Oliveira et al., 2018), in addition to identifying the types of evidence and the way research is conducted on a given topic (Munn et al., 2018). This scoping review protocol has been registered in Open Science Framework (OSF) Registries under the DOI 10.17605/OSF.IO/8MRPG, (osf.io/8mrpg) (Szpalher et al., 2021) and will be conducted according to rigor methodology proposed in the Manual for evidence synthesis by Joanna Briggs Institute (JBI) for Scoping Reviews -2020 version (Peters et al., 2020).
The Preferred Reporting Items for Systematic Reviews and Meta-Analysis: Extension for Scoping Review (PRISMA-ScR) Checklist (Tricco et al., 2018) will be used to detail the flow, by selecting the source and presenting the evidence, according to the JBI (Peters et al., 2020). Seeking to offer a straight forward process, with clarity and rigor in the evaluation (Finn et al., 2021), the scoping review methodology based on scoping review framework will be used, and its steps of scoping review process proposed by Peters et al. (2015), are demonstrated below:

Stage 1: Defining and aligning the objectives and question
This scoping review aims to map instruments applied to diagnose insomnia to provide strategies to guide nurses' decision-making in the diagnostic process. The research questions for this review is: What are the instruments and scales for the assessment and diagnosis of insomnia in nursing practice?

Stage 2: Developing and aligning the inclusion criteria with the objectives and questions
The key elements of population, concept, context (PCC) mnemonic (Peters et al., 2020). will be used to develop, refine inclusion and exclusion criteria and construct a clear title for this scoping review.
Population -Studies examining children, young, adults, elderly, male and female, without geographical delimitation, age group, related or previous diseases, or language or year will be included in this review. Studies that approach evaluations performed by health professionals, such as nurses, doctors, psychologists and others. Context -Studies addressing the use of instruments and scales in the clinical or research areas, published in English, Portuguese, French, and Spanish. Validation studies of instruments that assess insomnia will also be included, regardless of the author's validation process. Studies using scales and tools that have not been validated will be excluded from the sample.

Concept -
Stage 3: Describing the planned approach to evidence searching, selection, data extraction, and presentation of the evidence Quantitative and qualitative studies (for example, randomized studies, case study, observational and others) will be included in the review along with secondary studies (literature reviews, umbrella, systematic with and without meta-analysis) and gray literature (doctoral thesis, master's dissertations, opinion texts, reports, Guidelines, Comments and Congress Proceedings). The studies will be evaluated in Portuguese, French, English and Spanish. The authors will incorporate keywords and terms from findings in the literature in addition to the proposed search strategies. A date limit for publication will not be adopted for the search and selection of studies, as we understand that the instruments have no expiration date and can potentially be useful regardless of the date of publication.
The search will encompass three stages (Peters et al., 2020). Initially, we will perform a limited search on PubMed Portal and CINAHL Base (via EBSCO) to analyze the titles, abstracts and indexing terms of the retrieved articles. Then, a search with the identified keywords will be performed in the Databases and Portals included. Finally, reference list of the identified studies will be analyzed to find additional sources to be included in scoping review.
The search strategy used in the pilot search is presented in Table 1, organized with the support of a Librarian with experience in academic research in University and applied on March 08, 2021. The same strategy will be adopted in other databases. The search on the Organizations' webpages mentioned will be free, without the adoption of a search strategy and without time limits.  (Peters et al., 2020).

The specific strategies for each base involved research based on Health Sciences Descriptors (DeCS) and Medical
Subject Headings (MeSH) and in related free terms, combined with the Boolean operators AND and OR. There was no time or language delimitation, restriction filters in this initial search. The results were analyzed by titles and abstracts as needed.
We observed the absence of scoping review and systematic review, with or without meta-analysis, addressing this study's proposed theme. It is noteworthy existing studies focus on insomnia-related pharmacology, economic costs, prevalence comparison, and effectiveness studies, in progress or completed. We also found studies focused on cognitive-behavioral or music therapies for insomnia. Thus, emphasizing the relevance of the research proposed in this protocol.

Stage 5: Selecting the evidence
Analysis of the titles/abstracts will be performed, and studies will be selected for a full reading by two independent reviewers. Articles that do not meet the inclusion criteria will be presented in the scoping review. Disagreements regarding the reviewer's selection of studies will be solved by a third reviewer with sleep medicine expertise. New articles will be retrieved Research, Society andDevelopment, v. 10, n. 4, e2810413736, 2021 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v10i4.13736 6 from the selected articles for a final analysis.
After this analysis, references will be searched in the selected articles in order to identify other important sources. The sample size presented in the articles is not criteria of inclusão ou exclusion for selecting the studies.

Stage 6: Extracting the evidence
An instrument for data collection a "blind" screening process, prepared by the reviewers, will be used as indicated in the JBI Manual (Table 2): Table 2. Detailing of scope review and data collection.

Detailing of scoping review
Search Detail: Tools and scales to assess insomnia Review Objective: Map existing evidence about instruments and scales stratification of insomnia. Research Question: What are the instruments and scales for the assessment and diagnosis of insomnia in nursing practice?

Inclusion Criteria
Population: Individuals from both genders and all age groups, evaluations performed by health professionals. Concept: Instruments and scales that assess aspects related to insomnia. Context: Clinical and research settings, without geographical delimitation, in addition to instrument validation studies.
Year: No limitation In: PubMed, CINAHL via EBSCOhost, Scopus, WoS and Free search.

Characteristics of the selected study after reading in full
Authors: Year and Periodic: Title: Design Study: Language: Name of instrument/scale: Did you need to contact the authors? By which email? Present aspects related to insomnia: This instrument is intended for children/adolescents/adults/elderly: Did the study attach the instrument/scale? If so, attach it here. If not, search the free internet for a better evaluation, and answer the question above.

Stage 7: Analysis of the evidence
Our goal is to identify aspects related to the assessment and diagnosis of insomnia. Authors of the studies will be contacted via email for clarification or additional information during the process of this review as needed. The contact will be made by one of the authors. Data extracted from the standardized instrument (Table 2) will be subjected to qualitative content analysis, in a descriptive way, and categorization of findings.

Stage 8: Presentation of the results
Zotero ® software (United States) will be used to organize results and remove duplicates. The Rayyan (Qatar Computing Research Institute, Doha, Qatar -QCRI ® ) software for systematic reviews (Ouzzani et al, 2016) will be used to ensure a "blind" screening process and minimize bias. The PRISMA-ScR flowchart for depicts the flow of information through the different phases will be presented in the scoping review. The results will be presented in graphs and tables.
Data will be categorized and summarized as described in Table 3: Just mention the validation process adopted Source: Own authorship.
Stage 9: Summarizing the evidence concerning the purpose of the review, making conclusions and noting any implications of the findings Final data will be summarized after an appraisal or a third reviewer and consensus of all reviewers. Results will assist nurses in choosing the appropriate insturment for assessment and diagnose of insomnia. Summarize of evidence will highlight the peculiarities of these instruments and in disseminating the evidence available for research and health practice.
The presentation of the data will, prior to the publication of the scoping review, by consensus of a third reviewer for final agreement. Our goal is to complete this scoping review in the period of 6 months, understanding that such a period of time is reasonable for complying with the proposal.

Results and Discussion
The exercise of clinical reasoning aids diagnostic accuracy and enables adequate targeting of nursing interventions to achieve better health goals (Freitas & Conceição, 2018). The synthesis of knowledge, proposed in this protocol will facilitate the nurse's clinical judgment (Lourenço et al, 2020), and the decision-making regarding the instrument or scale for insomnia.
This scoping review will assist nurses in the clinical reasoning process for identifying ND "insomnia". Inand out-ofhospital environments, as home care, can be opportune places to observe insomnia patterns for nurses. The accurate look, aided by instruments, can promote objectivity in the evaluation and decision making, where adequate sleep can influence the quality of life.
The authors' clinical experience with insomnia confirmed the need for a review of instruments that address aspects related to insomnia. This is a scoping review study, so it did not require the patient or general public involvement. As a review of literature, there are no study participants in active enrollment for this study. If the review presents ethical issues resulting from the sources of evidence, these will be discussed in the results.
This is the first comprehensive review to synthesize evidence of useful tools for insomnia assessment by nurses. The review of the literature will be conducted with support from a research librarian with expertise in scoping review search in eight databases.
Since it is a scoping review, the quality of evidence, effectiveness of interventions/therapies, and risk of bias will not be assessed. Beyond this, will be selected only publications written in Portuguese, English, Spanish and French due the shortage of studies in other languages.

Final Considerations
Given the need to perform this review to guide the nursing process in the diagnosis of insomnia, this study may also contribute to the evaluation of nurses who work in the investigation and treatment of individuals with insomnia symptoms, given the high prevalence of this condition, regardless of age, socioeconomic status, gender and geographic location.
After the mentioned search, the low volume of publications of scope reviews is emphasized, even with the encouragement of scientific entities and Organizations that provide guidance about reviews on the importance of conducting their studies.
Aiming to disseminate the knowledge attributed to this study, the results will be published in a peer-reviewed journal and will be presented at Congresses or health scientific events. This research received no specific grant from any funding agency in public, commercial or not-for-profit sectors.
In addition to the contribution to the research area, a proposal is planned for the NANDA-I Taxonomy to include an insomnia assessment instrument(s) as diagnostic indicators for the identification of ND. This scoping review sought to promote screening and diagnosis of insomnia in healthcare and research practices for nurses. Results will contribute to further develop the Defining Characteristics and Associated Factors of the ND "insomnia" in upcoming versions of the NANDA-I, with potential benefits for the Nursing Interventions (NIC) and of Outcomes Nursing (NOC) worldwide.