Review question/objective

The objective of this scoping review is to examine and map the non-pharmacological interventions implemented and evaluated to provide comfort in palliative care.

More specifically, the review will focus on the following questions:

1. What non-pharmacological interventions have been implemented and evaluated to provide comfort in patients with incurable and advanced diseases?

2. What are the characteristics (duration, dose and frequency) of these interventions?

3. In what contexts (home care, palliative care unit or hospice) are the non-pharmacological interventions implemented and evaluated?

4. In which populations (cancer and non-cancer patients) are the non-pharmacological interventions implemented and evaluated?

Background

The outcome of advancements in science and technology is increased life expectancy.1 Therefore the aging of populations in societies where death may be delayed allows us to predict a gradual increase in the prevalence of degenerative and disabling diseases and consequently sources of suffering.2,3 This is a challenge for health services and demands attention to the person in a holistic way, based on the biomedical model which focuses on the somatic aspects, i.e. beyond psychological, social and spiritual ones.4 This new holistic paradigm requires finding procedures that alleviate suffering and provide comfort. These are central goals of medicine, especially in palliative care (PC).

Callahan5 proposed two main goals for the 21^st century medicine: first, to prevent and cure diseases; second, to help human beings die in peace. Since death is inevitable, enabling people to die in peace is as important as preventing and curing diseases, thus the advent of PC as a response to the suffering associated with the process of dying.6 According to the World Health Organization, PC is "an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual."7(p84)

Confronting mortality, the gradual worsening of his condition, the debilitating physical symptoms, as well as the emotional and spiritual struggles experienced by a person with an incurable and advanced disease (IAD) make the process of living with the disease longer than necessary, painful and characterized by intense suffering.8,9 In addition, these people sometimes undergo treatments which have secondary effects, increasing their in anxiety, depression and body discomfort, which can consequently have a significant effect on their comfort and wellbeing.10,11

In this regard, pharmacological techniques have advanced, leading to better control of physical pain. However, PC extends beyond the relief of physical symptoms. It seeks to integrate the psychological, spiritual and social aspects in order to provide even more comfort to people with IAD.1,12 In fact, Kolcaba, in her theory of comfort defined it as "the satisfaction (actively, passively or co-operatively) of the basic human needs for relief, ease or transcendence arising from health care situations that are stressful" in the physical, social, psych spiritual and environmental contexts.13(p1178) Therefore, pain, suffering, fatigue, depression or anxiety, are factors that influence the level of comfort14,15, and for this reason we the reviewers use these related elements to describe the concept of comfort.

With the increase in the need for PC units1,16 comes a pressing requirement for improved care at the end of life to minimize suffering and to provide comfort. At the core of this work, as referred by Cicely Saunders,17 are nurses who pass on to patients a great feeling of comfort. In fact, nurses, given the proximity and amount of contact time with the person who is ill, are in a unique position to promote comfort.8 Indeed, from its origins until today, nursing has emphasized that its concern and goal is the promotion of comfort.18

Literature reveals that comfort is a concept that has been identified as a key element of care by theorists of the nursing discipline.19 However, its meaning is often implicit, hidden in the context and usually leading to ambiguity.20 The comfort theory, developed by Kolcaba, maintains that comfort is a desirable holistic purpose of the nursing discipline. Thus, nurses must perform an assessment of the needs of health care arising from stressful situations (such as advanced disease). These needs can be presented verbally and nonverbally by patients.13

Designing comfort measures to meet these needs is part of nursing interventions, as well as the revaluation of comfort levels after the implementation of these measures. As advocated by Kolcaba, "assessment (intuitive or formalistic) precedes intervention".21(p107)

The evaluation can also be intuitive (as when a nurse asks the patient if he is comfortable) or formalistic (such as through the observation of wound healing, by the administration of visual analogue scales or traditional questionnaires).21,22

Comfort interventions make patients feel strengthened in a personalized and intangible way. In this context it should be noted that patients who feel comfortable have a more peaceful death.23,24 "A peaceful death is one in which conflicts are resolved, symptoms are well managed, and acceptance by the patient and family members allows for the patient to 'let got' quietly and with dignity."21(p80)

Therefore, the use of non-pharmacological interventions as an intervention strategy to promote comfort, in the context of PC, has been increasing.25,26 It has been demonstrated that the use of complementary therapies in PC units increase patient satisfaction with care at the end of life.27

In this regard, some studies have been carried out on the implementation and evaluation of non-pharmacological interventions to provide comfort or other outcomes related to this concept, such as wellbeing, pain, suffering, stress, fatigue, anxiety or depression, particularly in patients with IAD.28-31

In these studies, hypnotherapy28 implemented in hospice patients and measured by the Anxiety and Depression Scale have been reported to have an effect on improving anxiety; and art therapy,29 implemented in PC units and measured by the Edmonton Symptom Assessment Scale have been reported to have an effect on improving pain, fatigue, depression and anxiety. Other studies have been carried out on the experiences of patients with IAD of non-pharmacological interventions. In these, aromatherapy, relaxation and mental images were used as interventions which provided feelings of relaxation, serenity and comfort.30,31 It should be noted that the aforementioned studies were performed only with cancer patients.

However, information on implemented and evaluated interventions, their characteristics, contexts of application and population is dispersed in the literature,25,32,33 which impedes the formulation of precise questions on the effectiveness of those interventions and therefore the conduct of a systematic review.

In other words, the literature on non-pharmacological interventions in PC reports in which much attention has been given to the somatic aspects of comfort33-35 have not identified the other dimensions of comfort covered by the different non-pharmacological interventions. Furthermore, it is known that different interventions have been implemented in different contexts;32,33 however, a summary of non-pharmacological interventions implemented in the context of PC does not exist. Furthermore the literature does not clarify the characteristics of the different non-pharmacological intervention programs. Finally the existence of non-pharmacological interventions implemented and evaluated in non-oncologic populations is unclear.

Thus, the objective of this mapping will be to clarify the above aspects. Without this clarification, it is not possible to proceed to the conduct of a systematic review on the effectiveness of an intervention aimed at comfort, in a particular context and/or population, or the effectiveness of certain characteristics intervention aimed at comfort.

Consequently, there are important questions about the nature of the evidence in this area that need to be answered before formulating a precise question on effectiveness. This scoping review aims to provide answers to these questions.

Since the use of non-pharmacological interventions can improve patient comfort with incurable and advanced disease (IAD), mapping the evidence on this issue as an initial step in the conduct of a systematic review is imperative.34,35

This scoping review will be guided by the methodology proposed for Joanna Briggs Institute for the conduct of scoping reviews,36,37 and aims to examine and map non-pharmacological interventions implemented and evaluated to provide comfort in people with IAD, their characteristics, their contexts and the type of advanced disease of these patients.

According to the Joanna Briggs Institute, "scoping reviews undertaken with the objective of providing a map of the range of the available evidence can be undertaken as a preliminary exercise prior to the conduct of a systematic review."36(p6) Therefore, this map will allow identify relevant issues in order to help advance evidence-based health care, develop knowledge, identify possible gaps and inform systematic reviews.

This scoping review is part of a research project which may lead to a systematic review focusing on the best evidence on the effects of non-pharmacological interventions on the comfort of people with IAD. In addition, this mapping will be help inform the development of appropriate and effective intervention(s) for patients with IAD in order to provide them with comfort.

An initial search of the JBI Database of Systematic Reviews and Implementation Reports, the Cochrane Library, Medline and CINAHL revealed that currently there is no scoping review (published or in progress) on this topic.

Inclusion criteria

Types of participants

This scoping review will consider all studies that focus on patients with IAD, 18 years or over, assisted by palliative care teams.

Types of studies

This scoping review will consider all studies that address non-pharmacological interventions implemented to provide comfort. These interventions may include, but will not be limited to, guided imagery, relaxation, therapeutic touch and massage.

It will consider non-pharmacological interventions implemented to provide not only comfort but also wellbeing and relief of pain, suffering, anxiety, depression, stress and fatigue that are concepts related to comfort.

Context

This scoping review will consider all non-pharmacological interventions implemented and evaluated in the context of PC. This will include specifically home care, hospices or palliative care units.

Types of sources

This scoping review will consider quantitative, qualitative studies and systematic reviews.

Quantitative designs include any experimental study designs (including randomized controlled trials, non-randomized controlled trials, or other quasi-experimental studies, including before and after studies), and observational designs (descriptive studies, cohort studies, cross sectional studies, case studies and case series studies).

Qualitative designs include any studies that focus on qualitative data such as, but not limited to, phenomenology, grounded theory and ethnography designs.

Systematic reviews include meta-analysis and meta-syntheses.

Search strategy

The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe the articles. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published in English, Spanish and Portuguese will be considered for inclusion in this review. Studies published in any year will be considered for inclusion in this review to capture how non-pharmacological interventions implemented and evaluated to provide comfort in palliative care has been researched and understood over time.

The databases to be searched include:

CINAHL Plus with Full Text

PubMed

Cochrane Central Register of Controlled Trials

LILACS

Scopus

Library, Information Science & Technology Abstracts

Scielo - Scientific Electronic Library Online

PsycINFO

The JBI Database of Systematic Reviews and Implementation Reports

Cochrane Database of Systematic Reviews

The search for unpublished studies will include:

ProQuest - Nursing and Allied Health Source Dissertations

Banco de teses da CAPES ( Brasil)

Teseo - Base de datos de Tesis Doctorales (Spain)

TDX - Tesis Doctorals en Xarxa (Spain)

RCAAP - Repositorio Cientifico de Acesso Aberto de Portugal

Initial English language keywords to be used will be:

comfort OR pain OR suffering OR anxiety OR depression OR stress OR fatigue OR well-being palliative; hospice; "home care" ; "end of life"; intervention

Articles searched will then be assessed for relevance to the review, based on the information provided in the title and abstract, by two independent reviewers. The full article will be retrieved for all studies that meet the inclusion criteria of the review. If the reviewers have uncertainties about the relevance of a study from the abstract is unclear, the full article will be retrieved.

Based on full texts, two reviewers will examine independently whether the studies conform to the inclusion criteria. Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

Studies identified from reference list searches will be assessed for relevance based on the study's title and abstract.

Data extraction

Data will be extracted from papers included in the review using a charting table aligned to the objective and question of this research (Appendix I), as indicated by the methodology for scoping reviews developed by the Joanna Briggs Institute.36

A data extraction instrument was developed (Appendix I); however this may be further refined for use at the review stage.

Two reviewers will extract data independently. Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

The two reviewers, independent of each other, will chart the "first five to ten studies using the data-charting form and meet to determine whether their approach to data extraction is consistent with the research question and purpose", as suggested by Levac, Colquhoun and O'Brien.38(p6) In addition, if it is necessary, primary authors will be contacted for further information/clarification of the data, as suggested by Arksey and O'Malley's framework.39

Data synthesis

The overview of the reviewed material will, where possible and appropriate, be synthesized and presented in a tabular summary (Appendix II) with the aid of narrative and figures.

For question 1, the tables and charts may include data indicated in Table 1:

For question 2, the tables and charts may include data indicated in Table 2:

For question 3, the tables and charts may include data indicated in Table 3:

For question 4, the tables and charts may include data indicated in Table 4:

The narrative analysis, made by categories, will describe the aims of the studies and the results related to the review question.

Conflicts of interest

The authors declare that there are no conflicts of interest.

Acknowledgements

The authors acknowledge the support provided by Health Sciences Research Unit: Nursing (UICISA: E), hosted by the Nursing School of Coimbra (ESEnfC).

References