By Ellen Feldman, MD

Altru Health System, Grand Forks, ND

Dr. Feldman reports no financial relationships relevant to this field of study.

SUMMARY POINTS

  • This study randomized 360 preoperative patients into six groups to receive: 1) standard anxiolytic treatment (ST), 2) ST plus a compact disk recording of guided imagery (CDRGI), 3) ST plus acupuncture, 4) ST plus individualized guided imagery, 5) ST plus reflexology, or 6) ST plus reflexology plus individualized guided imagery.
  • The group receiving ST alone showed no significant difference in measurement of level of anxiety pre- or post-treatment.
  • All groups receiving add-on integrative interventions showed a statistically significant reduction in preoperative anxiety; the groups receiving ST plus individualized interventions showed statistically significant greater reduction in anxiety than the group receiving ST plus CDRGI.
  • When looking at the four groups receiving an individualized treatment (plus ST), there is no statistical evidence pointing to superiority of any one treatment in reduction of preoperative anxiety.

SYNOPSIS: In a randomized, clinical trial investigating the treatment of preoperative anxiety, standard sedating medication with a specified add-on individualized integrative technique is the most effective intervention.

SOURCE: Attias S, Keinan B. Effectiveness of integrating individualized and generic complementary medicine treatments with standard care versus standard care alone for reducing preoperative anxiety. J Clin Anesth 2016;29:54-64.

Anxiety prior to surgery is common and can be a significant factor in postoperative morbidity and mortality.1 Multiple studies demonstrate that preoperative anxiety may negatively affect the course of surgery and the postoperative period (via increased use of anxiolytics and/or via direct physiological changes, including increases in blood pressure and pulse), but there are few controlled studies regarding reducing anxiety in this setting. Attias et al conducted a randomized, controlled trial investigating the relative effect of specific treatments on preoperative anxiety. Each arm of the study includes conventional or standard anxiolytic medication (ST) with or without a specified add-on integrative medicine treatment (IMT).

The aim of the investigation is to examine reduction of preoperative anxiety with ST alone compared with ST plus a generic IMT or ST plus an individualized IMT.

Conducted over a period of three years, Israeli researchers recruited patients on a general surgical ward. Out of 519 patients eligible for participation, 360 completed the investigation, including both baseline and post-intervention assessment of anxiety.

Randomization was accomplished by assigning patients to groups via sealed envelopes. Patients were assigned to either ST alone (premedication with a benzodiazepine); ST plus a commercially available compact disc recording of guided imagery recording (CDRGI); or ST plus one of the following individualized treatments randomized according to the day of the week: individualized acupuncture, reflexology, guided imagery or reflexology plus guided imagery, specific to the patient as per below. Each group completed the study with 60 patients.

Acupuncture treatment was individualized in accordance with the traditional Chinese medicine diagnoses. Reflexology points were selected “according to the patients’ mental and physical condition.” Guided imagery was specific to the surgical procedure. Anxiety was measured using a validated anxiety questionnaire, a Visual Analog Scale (VAS), with possible scores between 0 (no anxiety) and 10 (maximum anxiety). Participants were asked to complete the scale twice: once after entering the study and then again after intervention, but before surgery. Thus, both measurements were taken preoperatively within a 30-60 minute period. It is worth noting again that every patient received ST; dose and type of medication was left to the judgment of the anesthesiologist (either PO oxazepam 10 mg or diazepam 5-10 mg.)

Baseline scores of anxiety were elevated, with more than 70% of participants in all groups scoring higher than 4 (3 is generally the cutoff for moderate anxiety.)

Figure 1 shows anxiety scores pre- and post-intervention when comparing all groups receiving IMT + ST (n = 300) with ST alone (n = 60.) The consolidated group of 300 patients included the group receiving generic IMT (CDRGI) plus ST, as well as the four groups receiving individualized IMT plus ST.

Figure 1: ST Alone vs. ST + IMT: Preoperative Anxiety

Figure 1

All anxiety scores dropped post-intervention in the groups receiving IMT and ST, demonstrating a reduction of anxiety, although to different degrees (see Figure 2). The group receiving ST alone showed a mean increase in anxiety scores; this increase was not shown to be statistically significant.

Figure 2: Effect on Mean Anxiety Scores: IMT + ST

Figure 2

Figure 2 compares results from each group receiving any form of IMT (in combination with ST.) Statistical analysis (as explained by the authors) shows no significant difference in results when comparing the individualized IMT head-to-head. However, there was a statistically significant effect (P < 0.0001 for each) when comparing each individualized treatment to CDRGI.

COMMENTARY

Why all the worry about preoperative anxiety? Although there has been some historical thought that preoperative anxiety actually may be protective in the postoperative period,2 recent studies have found that high levels of preoperative anxiety are not desirable.1,3,4 These studies noted that preoperative anxiety levels correlate with longer hospital stays, adverse perioperative outcomes, and poorer patient satisfaction scores.3,4 Increased use of anxiolytic medication may lead to secondary problems such as excessive sedation, confusion, and interactions with anesthesia.5 Investigations looking at cardiovascular procedures have linked preoperative anxiety with increased mortality.6 Given the risks, many interventions to reduce anxiety in the preoperative period actively are being explored.

Preoperative education7 and music,8 as well as the interventions used in this study, all have been studied as alternatives or add-ons to conventional anxiolytic medication in a preoperative setting. All seem to have potential use in this arena, although well-controlled and well-designed studies are still needed.

However, there are few studies that look at the manner of administration of an integrative medical technique to determine if the modality itself affects outcome. There are few studies that look at relative efficacy of integrative techniques.1 These are the unique factors incorporated into the design and purpose of this investigation.

This study looked at adding IMT to a conventional benzodiazepine regimen and then, even more specifically, at the manner of administration of IMT — generic (in this case prerecorded on a CD) vs. customized. There is a mention that the relatively more robust effect of the individualized treatments may be due to the “human factor” — future studies looking at individualized treatments without hands-on involvement could be helpful in sorting this out.

Another aspect of the IMTs chosen for this study is that each has been studied in treatment of anxiety disorders.8,9 However, it is important to differentiate between a disorder of anxiety and an anxious mood or state occurring in the context of impending surgery. This study strictly looked into treatment of an anxious state (known as “state anxiety”) measured by self-assessment on a validated scale; there are no claims or implications for the treatment of anxiety disorder on the basis of this work. In this case, validation means that a measurement on the VAS correlates with other known measurements of state anxiety.10 Unfortunately, there is very little published information linking changes in physiologic parameters directly with measurements of state anxiety.

This may explain why the benzodiazepines used as ST in the study failed to show an effect on levels of anxiety. Previous studies have demonstrated moderate effectiveness of these agents in treatment of preoperative anxiety,11 so it is puzzling why they showed no effect here. It may be a factor of timing (determined by when the second measurement of anxiety was taken), but also may have to do with the subjective nature of the scale used to measure anxiety and the absence of any objective determinants of relief of anxiety. That is, there is no information from this study regarding objective measurements of any parameters related to an anxious state and so no way to know if measurements in addition to the VAS would have reflected an effect of these agents or been more sensitive to distinguishing effects from the various IMTs.

Relevant literature fails to fully explain if the perioperative risks related to preoperative anxiety are due to self-awareness of anxiety or expected physiological changes due to state anxiety, or a combination of the two factors. This is another area ripe for future exploration.

The authors made clear that theirs is an exploratory study and that there were no investigations into any positive or negative implications of the IMTs after the second measure of anxiety just prior to surgery. To definitively link IMTs to clinically significant preoperative anxiety relief and to reduction in perioperative complications linked with preoperative anxiety, it will be important for future studies to explore not only subjective measures of anxiety but also some objective measures as well (blood pressure, heart rate, or even length of time in surgery, postoperative complications, hospitalization length, etc.).

There is little doubt (as noted by studies mentioned above) that addressing anxiety in a preoperative setting is helpful in reducing perioperative complications. This study reinforces the idea that IMTs reduce the experience of anxious feelings during the preoperative period, and introduces the concept that the method of administration of the IMT may be as important as the type of IMT used.

Understanding how and why individualizing an IMT leads to increased efficacy will be important in advancing the field of integrative medicine. The relative ease of individualization makes this an area ripe for exploration. Of course, the flip side is that this study and others of a similar design rely heavily on expertise of a particular practitioner. This can add to difficulties identifying direct causal relationships as standardization challenging.

Essential elements in future studies include understanding the relationship between self-reporting an anxious state and exhibiting cardiovascular and other objective measures of this state. Changes in cardiovascular parameters with decline of self-assessed anxiety would be useful to explore as well. With this link clearly established, more definitive conclusions can be drawn.

The medical field appears to be rapidly moving toward adopting many integrative therapies as mainstream. Understanding specific efficacies and mechanism of action of each intervention will help cement legitimacy and propel this movement forward. Understanding how much individualized therapy contributes to their effect also will be an important consideration.

REFERENCES

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  2. Anxiety before surgery may prove healthful. The Free Library 2014. Available at: http://www.thefreelibrary.com/Anxiety+ before+surgery+may+prove+healthful.-a012291606. Accessed June 25, 2016.
  3. Hobson JA, Slade P, Wrench IJ, Power L. Preoperative anxiety and postoperative satisfaction in women undergoing elective caesarean section. Int J Obstet Anesth 2006;15:18-23.
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  8. Bradt J, Dileo C. Music Interventions for preoperative anxiety. Cochrane Database Syst Rev 2013; Jun 6:CD006908.
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  10. Facco E, Zanette G, Favero L, et al. Toward the validation of visual analogue scale for anxiety. Anesth Prog 2011;58:8-13.
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