Clinical effectiveness of psycho-educational interventions to reduce perioperative anxiety in oncology patient: A systematic review

Conductive Centre of the Revision

The Spanish Centre for Evidence Based Nursing: Collaborating Centre of the Joanna Briggs Institute

Panel of Review

Rodríguez Gonzalo, Ana. Research management. Ramón y Cajal Hospital; The Spanish Centre for Evidence Based Nursing: Collaborating Centre of the Joanna Briggs Institute

Cidoncha Moreno, M^a Ángeles. Research management. Health Service Osakidetza; The Spanish Centre for Evidence Based Nursing: Collaborating Centre of the Joanna Briggs Institute

González Formoso, Clara. Security management. Health Service Primary Care. Vigo; The Spanish Centre for Evidence Based Nursing: Collaborating Centre of the Joanna Briggs Institute

González Cebrian, Miryam. Care surgery nurse. Marqués de Valdecilla Hospital; The Spanish Centre for Evidence Based Nursing: Collaborating Centre of the Joanna Briggs Institute

Contact for Review

Name: Ana Rodriguez Gonzalo

Phone: [phone]

Fax:

Email: [email protected]

Background

According to global data of the Scientific Foundation's Spanish Association Against Cancer, approximately 6 million men and 5 million women were diagnosed with a malignant tumor in 2002. In both sexes, the most common cancer is lung, followed by breast, colorectal, stomach, prostate, liver, cervix and esophagus ^1;2.

Patients with cancer experience high psychological distress expressed with anxiety and/or depressive symptoms ^3-5. The diagnosis of cancer itself creates psychological disorders such as anxiety, which can affect how a patient manages pain and how he/she recovers from the treatment ^3;6;7. The prevalence of this psychological disorder in oncology patients is between 30% and 50% ^3;5.

Moreover, patients who are undergoing a surgical procedure are under a stressful situation, which can reduce their psychological well-being ⁸. If this psychological distress is combined with a cancer diagnosis, anxiety level is higher ^4;9-11. In fact prevalence of preoperative anxiety in adults varies between 11% and 80% depending on kinds of surgery, and between 60% and 90% in surgical patients who are also oncology patients, which requires greater attention to this patients to prevent anxiety disorders before surgery ^3;12-14. Specifically Lilja (1998)⁸ indicates that breast cancer patients are more stressed compared to other surgical patients, such as hip replacement patients, when assessed the day before surgery.

Patients waiting for major surgery experience multifarious anxiety reactions, like fear of the unknown, be concerned about the loss of independence, fear of surgical procedure, separation from family, uncertainty about what effect it will have surgery on his everyday life, fear of being incapacitated, fear of change in body image, complications, anaesthesia and/or negative perception of the future ^9;15. Therefore, it is important to understand surgical procedures and how they affect the patients and their relatives, to facilitate understanding and selection of care that can reduce suffering ^15;16.

Also, if a patient is overanxious, his physical recovery and his well-being can be affected, which will prolong the length of hospital stay, resulting in an increase in the cost of attendance ^17-20.

The relationship between preoperative anxiety and subsequent pain has been analysed and preoperative anxiety has been found to affect the patients pain experience after surgery; so patients with high preoperative anxiety level have an increased needs of subsequent analgesia.. On the other hand, perception of pain and anxiety often increases when patients feel a lack of control over the situation and this is very common near surgery ^21-24. Several studies evaluating women with breast cancer concluded that patients with high levels of anxiety before surgery, reported more pain after surgery and they needed more analgesia, as reported by Ozalp et al ^21;25. Katz et al suggest, moreover, the importance of controlling psychosocial variables in breast cancer to prevent postoperative pain, suggesting the design of preventive activities to anxiety control ²¹.

Due to the impact and distress generated by a surgical procedure in patients and their families, different studies have highlighted the importance of knowing what are the patients demands and of informing them about surgical process.

In a study by Lithner et al (2000)²⁶ patients before undergoing cholecystectomy requested information related to those factors that were generating anxiety, such as pain and the symptoms after surgery.

Other studies suggest the need to assess the individual patients needs to subsequently implement interventions that help reduce anxiety and give the patient a more positive surgical experience ²⁷, there is therefore, a need to find a balance between giving too little or too much information, responding to individual patients needs, as mentioned Maguire ^8;28.

In addition Gillies et al (2001)²⁹ alert us to the risk of providing inappropriate information regarding surgery. The amount of information a patient needs in the preanesthetic visit can vary considerably in each patient, responding to their different needs and expectations³⁰. Perks et al (2009) ¹³, indicate that also provide information related to the surgery is a patients requirement that contribute to their well-being.

One of the tools that can respond to these demands are preoperative psycho-educational interventions: as educational sessions where patients receive some form of information on the type of surgery, what to expect, express their needs and they are supported. Among the benefits described in this type of intervention, Stern's review (2005)²⁰ notes a reduction in the fear of surgery, decrease in the needs for sedation, increases in knowledge and skills, decrease of emotional distress and improvements in postoperative exercise performance and therefore patients have a better and more speedy recovery, together with n improved communication with patients and response to their needs. This approach can generate more satisfaction with the care provided and reduce postoperative pain ^20;31.

The effectiveness of providing information to patients who are undergoing surgery, has been a topic of research, however, the benefit of such interventions has yet to be demonstrated.

Authors such as Ehring et al (1987)³², have shown that in surgical areas such as; abdominal, thoracic, perineal and orthopedic, beneficial effects in have been shown in patient's well-being by providing information before surgery, although the benefit was not clear in the case of reducing anxiety ^32;33. Ali et al in 1989³⁴ showed that this type of intervention decreased anxiety in patients who were undergoing surgery for prostate cancer.

Meta-analyses by Devine et al in 1992³⁵ and Hataway et al in 1986³⁶ reviewed the impact of preoperative intervention in surgical patients, including primarily abdominal and thoracic surgery. Their findings suggest that the groups who received the pyscho-educational intervention had better results in fear, anxiety, pain and distress, but indicate considerable variability in the type of intervention carried out. They also note that a proportion of patients, about 30%, did not benefit from intervention, especially those patients who suffered from high anxiety levels. Negative or conflicting results of the intervention were related to unstructured interventions or kinds of presentation.

However Lilja (1998)⁸ noted that providing preoperative information to breast cancer patients did not reduce anxiety before surgery significantly, compared to the control group.

More recently a study by Belleau (2001)¹⁰ demonstrated a significant decrease in anxiety levels after surgery in women undergoing mastectomy who had received psycho-educational intervention in three sesions before surgery, but this relationship did not hold day before surgery.

A study by Chaudhri et al. (2005)³⁷ on the effectiveness of an educational intervention several days before colorectal surgery showed that patients in the intervention group had lower levels of anxiety and fewer days of hospital stay.

The trial by Cheung et al (2003)³⁸ evidence that patients will be undergoing hysterectomy for diferent causes and were receiving psycho-educational intervention before surgery, had lower levels of postoperative anxiety and pain. However there was no evidence that they requested lower doses of analgesia, although previous studies suggest that other patients receiving preoperative information reported less pain and required less analgesia ^28;39.

Kiyohara et al (2004)⁴⁰ showed that the level of anxiety before neurological surgery was lower in patients who had information about surgical procedure, but anxiety wasn't lower when they had information about their diagnosis.

These described studies reflect variability in their results found, include only cancer patients ^8;10;34;37 or surgical patients, both by oncologic procedures as for other processes ^{28;32;33;35;36;38-40}.

In addition, recent studies have evaluated educational interventions in specific diseases unrelated to cancer patients,that question the effectiveness of these interventions ^41-45.

A systematic review by Lee et al (2003)⁴⁴ examined the effectiveness of educational interventions for patients undergoing hip, knee or outpatient surgery, related to the type of anesthesia and possible complications before surgery, notes reduced preoperative anxiety levels in those subjects who had received an explanatory video and/or pamphlet, versus those who had received no intervention. This difference was not maintained when comparing the video versus printed information⁴⁴. Also the authors note that the evidence of improved outcomes after the educational intervention is not convincing, due to methodological differences of the trials, the interventions used and the measuring instruments used ^41;44.

Chirveches et al (2006)⁴² after analyzing principally patients who had undergone either general or trauma surgery (excluding cancer patients), indicate that the preoperative visit itself is effective in reducing situational anxiety but did not improve acute pain perception after surgery ⁴².

A trial by Sorlie et al (2007)⁴⁵ on the effectiveness of an intervention to reduce the anxiety associated with coronary bypass surgery, focusing on providing information, employing the use of video and emotional expression, showed that patients in the intervention group had lower levels of anxiety which were maintained in a subsequent one-year follow-up. However, a quasi-experimental study by Deyirmenjian et al (2006)⁴³ on the effectiveness of an educational intervention to reduce anxiety before surgery did not show similar effectiveness, noting that it could be that intervention was done just the day before surgery and authors warning about the need to assess previously the social and cultural background of patients.

Although there are many studies demonstrating effectiveness of educational interventions for control of preoperative anxiety, others suggest otherwise. Furthermore, the literature shows different ways of presenting an intervention, indicating great variability in the content, method of organization and presentation³⁶. Factors that may influence the success of an educational intervention could include: feelings of the patient is likely to have before and after surgery, information about anatomy area to be undergo surgery, possible complications, or lifestyle changes after surgery, how operating room is and wich surgical staff functions are²⁰, psychosocial support, vocational skills and/or exercises to be performed after surgery ^10;19.

Regarding the methodology of intervention, wide variability is also noted and can be structured or unstructured, it can be performed with audiovisual media, brochures, questionnaires, direct or telephone interviews with health staff. It can be conducted individually or in a group. There is disagreement about the benefit of group intervention compared to individual, as well Shuldham et al¹⁹ point out, though Hataway³⁶ in his review indicates that individual statements were better than group and suggests that we must take into account the level of anxiety and fear of the patient at the time to develop and design preoperative instructions, including psychological component. Shuldham¹⁹ also states that retention of preoperative information of a patient is greater when the instructions are individualized ¹⁰; and when videos and leaflets are combined^20;46. The review of Stern et al (2005)²⁰ on effectiveness of preoperative educational interventions with regard to knowledge retention and ability to adapt to changes after surgery, demonstrates the usefulness of information leaflets to improve patients skills. This is the most commonly used style of educational method., however the in depth use of video has not been explored. The authors also believe that giving instructions on behavioral patterns is useful for patients to improve their knowledge, noting the desirability of delivering an educational intervention before hospital admission. They found no significant differences between individual or group intervention²⁰. A strategy recently tested is a computer education program for patients who are going to undergo breast reconstruction. Patients reported that in addition to quickly understanding the basics of breast reconstruction, it helped to have realistic expectations about the outcome ⁴⁷.

Regarding the right moment to do educational preoperative intervention there is a greater discrepancy, considering that probably the most effective psycho-educational intervention is taking place between 5-14 days pre-admission^10,19, being reinforced later the day of admission and the day before surgery¹⁰, as indicated by Belleau et al¹⁰, in assessing the effectiveness of preoperative intervention in patients undergoing a mastectomy.

Meeting the needs of cancer patients about to undergo a surgical procedure, it may provide a rationale for design and implementation of intervention strategies that help patients improve their quality of life and better recover ^3;10;15. Thus, we propose a systematic review to examine the effectiveness of psycho-educational interventions to reduce the impact of the surgery, improving their levels of perioperative anxiety and postoperative pain in oncology patients.

Review Question/Objectives

The review question is: How effective are preoperative interventions at reducing perioperative anxiety on cancer patients compared with conventional treatment?

Main Objective:

To assess and summarize the best available scientific evidence on the effectiveness of preoperative psycho-educational interventions to reduce perioperative anxiety in oncology patients.

Secondary Objectives:

• To identify effective interventions in the presurgical visit to the prevention and control of postoperative pain of oncology patients.
• To identify characteristics of effective interventions to decrease perioperative anxiety and postoperative pain.

Inclusion Criteria

Types of studies:

This review will consider all randomized clinical trials, enabling the identification of current best evidence on the effectiveness of the preoperative visit in oncology patients, which is disseminate in Spanish and English. In the absence of randomized clinical trials (RCT), it will consider for inclusion other research designs such as controlled clinical trials without randomization (CCTs).

Types of participants:

This review will consider studies that include patients over 18 years who will undergo major surgery for diagnosed process of cancer or for cancer suspicion. We define major surgery as surgery that requires general anesthesia and hospital stay. Participants will be considered, regardless of the type of cancer and the type of surgery.

Types of interventions:

This review will consider psycho-educational interventions used in the preoperative visit of patient undergoing major surgery for diagnosed process of cancer or for cancer suspicion. We consider preoperative visit, the structured visit performed before surgery, which provide at least psycho-educational intervention versus conventional therapy, where patients receive some form of information before an operative procedure. We define conventional treatment consisting of: a non-standard visit focused on the retention of fasting, operating field preparation, administration of sedatives or take no action. We define psycho-educational treatment as educational sessions where patients receive some form of information on the type of surgery, what to expect, express their needs and they are supported.

Types of Outcomes Measure:

This review will consider studies that include the following outcomes: preoperative and postoperative anxiety assessed by specific standardized and validated anxiety instruments and postoperative pain.

There are no exclusion criteria used in this review.

Search strategy for identification of studies

The search strategy aims to find both published and unpublished studies. It will use a search strategy of three steps. In the first step there will be a limited search of MEDLINE, CINAHL and PsycINFO, followed by analysis of the words in the title and abstract to identify keywords, and index term used to describe relevant articles.

In the second step there will be a second extensive search using all keywords and index terms identified in the following databases: COCHRANE LIBRARY (Cochrane Central Register of Controlled Trials, CENTRAL,), EMBASE, CINAHL, CUIDEN, PsycoINFO, PUBMED, Science Citation Index (ISI WEB OF KNOWLEDGE), BIREME, IME.

Search for gray literature searches the following databases:

• OpenSIGLE (System for Information on Grey Literature in Europe)
• CINDOC del CSIC (Centro de Información y Documentación Científica del Consejo Superior de Investigaciones Científicas)
• Dissertation Abstracts International
• Proceedings First Database
• Database for Spanish Dissertations: TESEO
• National Library of Medicine Gateway
• Grey Literature Report (through New York Academy of Medicine website)
• Google Scholar
• AHRQ: Agency for Health Care Research and Quality
• CURRENT CONTENTS
• EXPANDED ACADEMIC INDEX

Will include papers presented at conferences and meetings of oncology, as well as guides and documents to disseminate scientific societies. Oncological scientific societies include:

• ACS (American cancer society)
• ECCO (European cancer organization)
• UICC (International union against cancer)
• AECC (Asociación española contra el cáncer).
• ONS (Oncology Nursing Society).

Finally, the third step is a search of the reference list of all reports and relevant articles selected, carrying out a secondary search of articles from the references to find additional studies.

There will be a manual search reverse of the most prestigious journals in the field of surgery, oncology and / or oncological surgery:

• Surgery
• Oncology
• American surgical oncology
• Psycho-oncology
• Surgical oncology
• Oncology Nursing Forum

We search from the beginning of the database until December 2010.

The search aims to identify studies published in both Spanish or English languages and the searches will be conducted in both Spanish and English

Defining MeSH search terms:

• Intervention (MeSH)
• Education OR Early Intervention (MeSH)
• Psychotherapeutic processes (MeSH)
• Neoplasms (MeSH)
• Anxiety (MeSH)
• Pain Postoperative (MeSH)
• Operative OR Surgery OR Surgical procedures (MeSH)

MeSH terms will be expanded and adapted to combine the rules of each database. Equivalent terms will be used in Spanish for databases using the Spanish language.

If necessary, authors of studies identified as potentially suitable for inclusion, will be contacted for provision of data that may be missing or to for clarification of methodological details or to request further published or unpublished data.

Two reviewers independently will review the title and abstract to assess whether they meet the criteria of inclusion in articles; where it is not clear will be necessary to follow the same process with the full article.

Assessment of methodological quality

The articles selected for retrieval will be evaluated by two independent reviewers based on their methodological validity before being included in the review using standardized instruments critical appraisal of the Joanna Briggs Instrument Systematic Review of Effectiveness (JBI-MAStARI) (Appendix I).

We will use a predefined critical appraisal score as a cutoff for inclusion in the review, the affirmative answer (Yes) for 5 questions out of a total of 10 questions is required. Any disagreements that arise between the reviewers will be solved by discussion, If still unable to reach an agreement, we will go to a third reviewer.

Assessment of methodology studies will focus on selection bias, information and performance.

Data Collection

Data will extract from the articles included in the review using a data extraction standardized tool JBI-MASTARI (Appendix II).

Data will be extracted by two independent reviewers to assess whether they reach the same results. All results are subject to the double entry of data to avoid transcription errors.

Extracted data will be include specific details about characteristics of the interventions - such as when it is performed, intervention team, number of meetings-, populations, details of research designs and relevant results to the question review and specific objectives.

Data Synthesis

The comparison of the studies will be according to the study population, type of intervention, type of surgery and outcome variables measures.

Clinical heterogeneity will be assessed.

Statistical heterogeneity of included studies will be tested using the standard chi-square test and considered; because the low power of the test to detect heterogeneity if the number of studies is relatively low or when individual studies are small, a P- value of 0.10 will be used (p <0.1). The I² index will also be used, considering the values of 0%, 25%, 50% and 75% as none, low, moderate and high heterogeneity I².

If studies are homogeneous, data will be pooled in a statistical meta-analysis using the software program JBI SUMARI. If there is statistical heterogeneity, results will be analysed by clinically homogeneous subgroup, first considering age and type of surgery, or use the model of random effects analysis, as appropriate.

The effect measures used: the Odds Ratio (for categorical outcome data) or RR and weighted mean differences (for continuous data), with a confidence intervals of 95%.

Where statistical pooling is not appropriate or possible, the findings will be summarised in narrative form.

Acknowledgements

Nursing management of Ramon y Cajal Hospital for their support. M^a Consuelo Company and Angel Alfredo Martinez for their assistance in the preparation of this protocol.

Conflict of interest

Authors declare no conflicts of interest in the review conducted.