Authors
- Nrgaard, Marianne W
- Pedersen, Preben U PhD
Abstract
Review question/objective: The objective of this systematic review is to identify, appraise and synthesize the best available evidence on the effectiveness of clinical hypnotic analgesia in the management of procedural pain in adults undergoing minimally invasive procedures.
More specifically the review question is:
What is the effectiveness of clinical hypnotic analgesia as an adjunct to usual analgesics compared to usual analgesics (pharmacological interventions) used in adults during minimally invasive procedures in the management of procedural pain.
Background: Many patients undergo invasive procedures. It is widely acknowledged, that these procedures can be accompanied by pain and discomfort when patients are awake throughout the procedure and a light conscious sedation is used.1-6 Unrelieved pain causes unnecessary discomfort, delayed healing, and longer hospital stays for the patients.7 Despite technical advantages, patients often experience anxiety and pain that may exceed their coping strategies and may require a complementary patient-orientated intervention to help patients manage pain and anxiety together with the usual analgesic used.8
The use of non-pharmacological therapies has gained acceptance in clinical settings as suitable adjuncts to the usual analgesics used during medical invasive or minor surgery procedures.9 This increase is probably due to a growing demand from the patients and therefore more hospitals offer these treatments. Furthermore healthcare practitioners are searching for alternative treatments that are relatively easy to administer, and have fewer side effects than the usual analgesics.10
Hypnotic analgesia is a technique for diverting attention for pain and anxiety. It is most often used prior to or during a painful procedure. Hypnosis alters state of consciousness, allowing for a more suggestible state, thus making it easier to change the perception of pain.11
Based on previous reviews of the literature it appears that hypnotic analgesia is one of the most promising non-pharmacologic adjunctive treatments even though there are variations and lack of clarity in the outcomes of the clinical trials.12,13
Hypnotic analgesia has been used in numerous randomized, controlled trials in an attempt to ameliorate pain and the anxiety associated with a wide variety of medical procedures.4,13-14 Furthermore the amount of analgesics used during the procedure was in some studies shown to be reduced and adverse events decreased.2-4
The invasive procedures where hypnotic analgesia has been used with more effectiveness compared to no treatment or standard care include large core breast biopsy, percutaneous tumor treatment, needle electro-myography, radiological, percutaneous vascular, cardiovascular and renal procedures.2-5,15-16
In 2003, a meta-analysis based on 20 published studies showed that an average of 89% of the surgical patients benefited from adjunctive hypnosis treatment compared to patients in control groups.17 Benefits of hypnosis were evident in each of the outcome categories (anxiety and depression, pain, pain medication, physiological indicators, recovery (e.g. postoperative vomiting) and procedure time.17
Another meta-analysis in 2008 was conducted on 26 clinical trials (n = 2342, both adults and children) on the effect of hypnosis to reduce emotional distress related to medical procedures.12 It indicated that approximately 82% of the patients who have undergone medical procedures and received hypnosis showed lower levels of emotional distress compared to patients in a control condition.12
A systematic review and a literature review13,14 summarizing more than 30 controlled trials focused on the use of hypnosis treating acute/procedural and chronic pain problems. These two reviews indicated that hypnotic analgesia used in clinical trials resulted in greater decreases in a variety of pain outcomes compared to no treatment or standard care both on acute and chronic pain in adults.13,14
In terms of acute/procedural pain, the findings in the recent literature review14 in 2009 suggested that hypnosis compared to no treatment or non-hypnotic interventions resulted in significantly greater reductions in pain outcomes in at least 50% of the studies and performed as well as the control conditions in the remaining 50%.14 This review also concluded that methodological issues (lack of standardization of hypnotic interventions, small sample size etc.) should be addressed in future studies.14
An initial search in the databases CINAHL, the Joanna Briggs Institute Library, PUBMED, Cochrane Library and PsychINFO shows that no systematic review exists on this topic and target population. The search in Cochrane showed a protocol which had been submitted and accepted in 2009. However a personal contact to the first author of the review did not come up with a date for a complete review.
There is therefore a need for a systematic review to synthesize the updated best available evidence on the effectiveness of hypnotic analgesia in the management of procedural pain, and anxiety, in adults undergoing minimally invasive procedures.
Furthermore a systematic review could provide recommendations to practitioners to use hypnotic analgesia as an adjunct to usual analgesics for amelioration of procedural pain in their patients undergoing a minimally invasive procedure.
Hypnotic analgesia used in dental settings, burn care, and other non-invasive procedures will not be addressed as a part of this review. Neither will hypnotic analgesia used for children and adolescents, as they represent a different population. Hypnosis in the management of labor pain will be excluded, as a specific systematic review was published in 2012.18
Definitions:
For the purposes of this review, the following definitions will be used:
Minimally invasive procedure: is any procedure (surgery or otherwise) that is less invasive than open surgery used for the same purpose. A minimally invasive procedure typically involves the use of instruments and requires the penetration of tissue or the invasion of a body orifice.8, 19
Procedural pain: Pain that occurs during or after the procedure. Occurs in response to specific tissue damage and usually resolves once the injury heals.20
Procedural anxiety: Acute procedure anxiety is an excessive fear and/or anxiety about a medical procedure that results in acute distress in anticipation of the procedure or during the procedure.8
Consumptions of pain medication (analgesics): Patients intraprocedural use of analgesic agents (beyond the premedication).3
Procedure time: The entire time the patient occupied the procedure room.
Adverse events: Defined as all occurrences that would attract extra medical attention to restore hemodynamic and cardiorespiratory stability during the minimally invasive procedure, e.g. oxygen desaturation, prolonged bradycardia, hypotension, prolonged hypertension.3
Clinical hypnosis : A procedure in which a person is guided by another to respond to suggestions for changes in subjective experience, alterations in perception, sensation, emotion, thoughts or behavior.21
Hypnotic analgesia: Can be defined as a state of attentive and receptive concentration that allows patients to explore their own abilities to cope with a painful and distressing situation.11
We have in this review used the terms hypnosis, visualization, and guided imagery as interchangeable words as described by Vickers and Zollmann.22
Article Content
Inclusion criteria
Types of participants
This review will consider studies that include patients, males and females over the age of 18 years, who are undergoing minimally invasive procedures that cause significant acute pain as assessed by medical professionals or by patient self-report.
Types of intervention
This review will consider studies that evaluate
a) Clinical hypnotic analgesia as an adjunct to usual analgesic
Comparator: Usual analgesics used during the invasive procedure
Types of outcomes
This review will consider studies that primarily include the following outcome measure: patient rated procedural pain intensity. This outcome is commonly measured in analgesic trials and is pivotal to the evaluation of the efficacy of hypnosis for acute pain.
Additionally, the following outcomes, when appropriate and available, will be analyzed: patient rated pain; patient rated anxiety, patient rated distress. The amount of pain medication (analgesic) used during the procedure, procedure length, and observer rated adverse events.
Validated scores and scales are used for assessing the outcomes pain, anxiety and distress.
Types of studies
This review will consider any experimental study design including randomized controlled trials, non-randomized controlled trials, quasi-experimental, before and after studies, for inclusion.
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 analysis of the text words contained in the title and abstract, and of the index terms used to describe article. The initial search terms have been chosen in discussion with a research librarian with the aim of identifying the maximum number of articles possible. 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, Danish, Swedish and Norwegian will be considered for inclusion in this review. Studies published from their inception to November 2013 will be considered for inclusion in this review.
The databases to be searched include:
PubMed, CINAHL, Embase, Scopus, Swemed+, Cochrane, PsycINFO, MEDLINE, JBI Library, Science Direct, Spingerlink, Mosby's Nursing Consult, Web of Science, Expanded Academic ASAP, Sociological Abstracts and ProQuest Dissertationa and Theses.
The search for unpublished studies will include:
Conducting an online search of databases and websites including:
- MedNar
-Google Scholar
-Trip database
- National Institutes of Health (NIH) Clinical Trials Databases (Host: http://www.clinicaltrials.gov)
- American society of Clinical Hypnosis (ASCH) (Host: http://www.asch.net/)
- The American Board of Medical Hypnosis (ABMH) (Host: http://www.abmedhyp.net/)
- The American Society of Clinical and Experimental hypnosis (SCEH) (Host: http://www.sceh.us/)
- International Society of Hypnosis (ISH) (Host: http://www.ishhypnosis.org/)
The combined keywords to be used will be:
Pain intensity or pain management or anxiety or distress or acute pain or invasive medical procedure pain or pain
AND
Clinical hypnosis or hypnosis or visualization or visualisation or guided imagery or clinical hypnotic relaxation or hypnotic analgesia or imagery psychotherapy or relaxation or analgesia or patient controlled or adjunctive hypnosis
AND
Surgical procedures or minimally invasive or invasive procedures or medical procedures
Assessment of methodological quality
All studies identified during the databases search will be assessed for relevance to the review based on the information provided in the title and abstract. For papers that appear to meet the inclusion criteria, a full report of the paper will be retrieved. The study will be assessed for applicability to the inclusion criteria in order to determine the relevance to the review objective.
Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I ). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.
Data collection
Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives.
Data synthesis
Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate.
Conflicts of interest
None identified
Acknowledgements
The reviewers gratefully acknowledge the research librarian, Vibeke Witt, The Metropol Library, Copenhagen, Denmark for her assistance with the literature search and strategy.
References
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Appendix I: Appraisal instruments
MAStARI appraisal instrument[Context Link]
Appendix II: Data extraction instruments
MAStARI data extraction instrument[Context Link]
Keywords: Clinical hypnotic analgesia; hypnosis; pain intensity; pain management; anxiety; distress; acute pain; invasive medical procedure pain; pain