kekecs - the effectiveness of suggestive techniques in reducing post-operative side-effects

8/10/2019 Kekecs - the Effectiveness of Suggestive Techniques in Reducing Post-operative Side-effects

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XXX 2014 Volume XXX Number XXX www.anesthesia-analgesia.org 3

Publication bias was assessed using Begg and Mazumdarrank correlation, the random effect variant of Egger test,Duval & Tweedie trim and fill method, and the inspectionof the funnel plots.

STATISTICAL ANALYSIS

Calculating Treatment EffectCorrected Hedgesg(g) was used as a measure of effect size.

If the mean and standard deviation were not reported inthe original studies, effect sizes were calculated using otherstatistics, using the equations by Johnson and Eagly,13andLipsey and Wilson.14 If necessary, effect sizes were aggre-gated according to Rosenthal and Rubin15 and Decoster.16For studies that did not report any test statistics or signifi-cance values for nonsignificant results, we imputed g = 0(referred to as imprecise inference from here on).

Statistical AnalysisStatistical analysis was performed using the metafor package(v1.9-3)17 in R (v3.1.1). Statistical heterogeneity (I2) yieldedmedium to high values that supported the application of a

random-effect approach. Random effect meta-analysis wasused to obtain the general effect size of suggestive methodson postoperative side effects, to assess publication bias, andto have a reference point for later sensitivity analyses. Meta-regression was used to investigate the risk of bias for all out-come variables including all categories from the CochraneRisk of Bias Assessment Tool as binomial variables: 0 = lowrisk of bias; 1 = unclear or high risk of bias. A permutation-

based technique was used to control for multiple hypothesistesting. Sensitivity analyses were performed to further inves-tigate significant moderator effects by excluding studies withunclear or high-risk ratings. Moderator effects of impreciseinference and special care (see data extraction) were tested as

well, accompanied by appropriate sensitivity analyses.Subsequently 3 meta-regressions were executed for

each outcome testing the moderating effect of hypnosisinduction, live versus recorded presentation, and surgerytype (minor versus major surgery). In addition, sensitivityanalyses were also performed on datasets split by modera-tor conditions. One study in the anxiety and pain datasetswas omitted from the analysis of the effect of surgery type

because of insufficient information to determine surgerytype.18Because a relatively high risk of bias was uncoveredin the study pool, threshold for statistical significance wasset to P< 0.01, and 99% confidence intervals (CIs) are dis-played in all analyses except for risk of bias assessments

in which the traditional P< 0.05 was retained. (Appendix1, Supplemental Digital Content 1, http://links.lww.com/AA/B9, summarizes references of text on statistical meth-ods used for the assessment of publication bias, calculat-ing treatment effect, and analysis of the data).

RESULTS

Study SelectionAs Figure 1 shows, 139 records were selected for fulltext evaluation. Sixteen of these could not be retrieved(Appendix 5, Supplemental Digital Content 5, http://links.lww.com/AA/B13), and 16 were duplicate publications.From the remaining 107 publications, 56 used hypnosis,

49 used therapeutic suggestions, and 2 used both. All non-RCTs, studies on pediatric patients, studies that did not

report outcome of interest, and trials in which suggestionswere given only during general anesthesia were excluded.Twenty-six studies were retained at the end of the exclusionprocess incorporating 1890 patients (range: n= 12346) ofwhich 13 applied hypnosis, 11 therapeutic suggestions, and2 both in separate groups; 13 used live and 13 recorded pre-sentation; and furthermore 14 were performed in major and11 in minor surgical procedures (not enough information onsurgery type in 1 study). Cholecystectomy (6 studies) andhysterectomy (4 studies) were the most commonly used sur-gical procedures. Four studies contained >1 relevant experi-mental condition. Table 1 lists the study characteristics.

General Effects of Suggestive TechniquesWe found a significant reduction in postoperative anxiety(g= 0.40; 99% CI = 0.130.66; P< 0.001) and pain intensity(g= 0.25; 99% CI = 0.000.50; P = 0.010), whereas no sig-nificant effect was noted for postoperative analgesic drugconsumption (g= 0.16; 99% CI = 0.16 to 0.47; P= 0.202) andnausea (g= 0.38; 99% CI = 0.06 to 0.81; P= 0.026).

Analysis of ModeratorsAs apparent in Figures 25, there is a considerable amountof heterogeneity in the total study sample. To account forthis heterogeneity, moderator and sensitivity analyses wereperformed, the results of which can be found in Figure 6.

Figure 1.Flow diagram.

Banu 4 Color Fig(s): F7-8 09/29/14 20:46 Art: AAJ-D-14-00342
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Hypnosis InductionThe moderating effect of hypnosis was not statistically

significant for any outcome; however, sensitivity analysisled us to different conclusions on the effects of therapeu-tic suggestions and hypnosis. While pooled effect size andCIs show a small nonsignificant effect for therapeutic sug-gestion studies on all outcomes, hypnosis had a significantmedium-sized effect on postoperative anxiety and althoughnot significant, hypnosis effect sizes were generally higherin all other outcomes as well.

Presentation MethodLive presentation was more effective for decreasing pain rat-ings than recorded presentation (z = 2.18; P = 0.029); how-ever, recordings were superior for reducing pain medication

requirement (z= -2.08; P= 0.037). Although these moderatoreffects are statistically not significant, the sensitivity analysis

also indicated differentiation in the effects of the 2 presenta-tion methods: we found a medium-sized significant effect oflive presentation on anxiety and pain intensity, while recordedpresentation yielded no significant results on any outcome.

Surgery TypeModerator analysis did not show significant moderatoreffect of surgery type; nevertheless, sensitivity analysis ledto somewhat differing conclusions for the effectiveness ofsuggestive interventions used in minor and major surger-ies. Both interventions used in minor and major proceduresreduced anxiety with a similar medium effect size, and nei-ther had a significant effect on pain medication requirement

Figure 2.Effects of suggestive techniqueson postoperative anxiety. The effect isexpressed as corrected Hedges g withassociated 99% confidence intervals (CIs).Black squares show the point estimates ofthe effect of individual studies with hori-zontal lines corresponding to 99% CIs. The

white diamonds (subtotal) represent thepooled estimates and 99% CIs for eachsubgroup, and the black diamond (total)shows the pooled estimates and 99% CIfor all studies. The sample sizes of thesuggestion (N sg) and control groups (Ncg) of each study and the heterogeneityscores for each subgroup analysis are alsodisplayed.



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6 www.anesthesia-analgesia.org ANESTHESIA & ANALGESIA

Suggestions for Reducing Surgical Side Effects

or nausea. However, while studies on major surgeriesshowed negligible effect sizes for reducing pain and analge-sic requirement, pooled effect sizes were medium sized forthe same outcomes in minor procedures.

Risk of Bias and Effects of Imprecise

Inference and Special CareA summary graph of risk of bias is displayed in Figure 7,

and the results of risk of bias assessment for each study arelisted in Figure 8. Meta-regression identified 2 methodologi-cal moderators as significant: random sequence generationin the anxiety dataset (z = 2.48; P = 0.018) and blindingof personnel in the nausea dataset (z = 3.84; P = 0.003;Table 2). Sensitivity analysis revealed that with the exclu-sion of studies having high or unknown risk of bias, theeffect of suggestive techniques on postoperative anxietyis no more significant (g = 0.16; 99% CI = 0.30 to 0.60;P= 0.376). Exclusion of studies with high or unknown riskon blinding of personnel produced a slightly higher pooledeffect size than the model without moderators in the nau-sea dataset (g= 0.49; 99% CI = 0.10 to 1.08; P= 0.032); the

effect remained nonsignificant. Effect on postoperative painand pain medication requirement was unaffected by meth-odological quality. There was no moderator effect of impre-cise inference, and that studies with special care had highereffects compared to studies with no special care (Table 3).

There was no indication of publication bias based onfunnel plots and asymmetry tests (Fig. 9). Duval & Tweedietrim and fill method does not change our interpretation for

anxiety, pain intensity, and nausea. However, it predicted 4missing studies from the right (positive) side for the painmedication dataset yielding a slightly higher but still non-significant effect (g= 0.31; 99% CI = 0.02 to 0.63; P= 0.015).

DISCUSSIONWe reviewed the results of 26 studies to investigate theeffects of suggestive interventions in surgical settingsand to explore the factors that moderate their effective-ness. Results indicate that suggestion interventions had a

beneficial effect on postoperative anxiety and to a lesserextent on pain intensity, while we did not find convinc-ing evidence to support the effectiveness of suggestive

Figure 3.Effects of suggestive techniqueson postoperative pain intensity. The effectis expressed as corrected Hedges gwithassociated 99% confidence intervals (CIs).Black squares show the point estimates ofthe effect of individual studies with hori-zontal lines corresponding to 99% CIs. Thewhite diamonds (subtotal) represent thepooled estimates and 99% CIs for eachsubgroup, and the black diamond (total)shows the pooled estimates and 99% CI

for all studies. The sample sizes of thesuggestion (N sg) and control groups (Ncg) of each study and the heterogeneityscores for each subgroup analysis are alsodisplayed.



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interventions as a whole in reducing postoperative analge-sic use and nausea. Our findings yielded small to mediumeffect sizes for the effects of suggestive techniques on thestudied outcome measures, which are comparable to pre-vious reports57,b; however, we were more conservative inhow we interpreted these results. The reason for our cau-tion is the relatively high risk of bias in these studies mostlyoriginating from lack of blinding of participants, studypersonnel and data assessors, and the lack of descriptionof random sequence generation and allocation methods.

Particularly, our analysis points out that in a large portionof the studies showing a beneficial effect on postoperativeanxiety, random sequence generation is described insuffi-ciently, and that if we omit these studies, the previouslyhighly significant effect fades away. Furthermore, the effecton pain intensity is only at the border of statistical signifi-cance. Thus, we conclude that although results point in theright direction, we need more methodologically rigorous

studies to get a clear picture of the effectiveness of sugges-tive interventions in surgery.

Contrary to our hypothesis but consistent with the reportof Schnur et al.,5we found that only hypnosis reduced post-operative anxiety, and we found no significant effects fortherapeutic suggestions on any of the assessed outcomemeasures.

The effect of presentation method revealed a complexpicture. Our moderator and sensitivity analyses yieldedthat only interventions using live presentation were effec-

tive for reducing postoperative anxiety and pain intensity.However, there was no substantial difference in the effec-tiveness between therapeutic suggestions and hypnosisfor reducing analgesic requirement and nausea. Previousresearch reported mixed results about the effects of pre-sentation method. While Schnur et al.5supported the supe-riority of live presentation compared to recordings forreducing postoperative distress, 2 other meta-analysesdid not find a significant difference between face-to-faceand taped presentation.4,6 Although Schnur et al.5 onlyaddressed 1 outcome, Montgomery et al.4used a combinedeffect size of several outcomes during the assessment ofthis moderator effect. Previous reports also point out the

bThe markedly higher intervention effects reported by Montgomery andcolleagues4 may be explained by the facts that contrary to the presentmeta-analysis non-RCTs were included while studies not reporting ade-quate statistics were excluded from their analysis, and that they used afixed effect model.

Figure 4. Effects of suggestive tech-niques on postoperative pain medicationrequirement. The effect is expressed ascorrected Hedges gwith associated 99%confidence intervals (CI). Black squaresshow the point estimates of the effectof individual studies with horizontal linescorresponding to 99% CIs. The white dia-monds (subtotal) represent the pooledestimates and 99% CIs for each subgroup,and the black diamond (total) shows thepooled estimates and 99% CI for all stud-ies. The sample sizes of the suggestion (Nsg) and control groups (N cg) of each studyand the heterogeneity scores for eachsubgroup analysis are also displayed.



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high correspondence between moderating factors; that is,studies using live presentation also tend to use hypno-sis instead of therapeutic suggestions and preoperativeinstead of intra- or postoperative presentation of the inter-

vention. Therefore, reasons for differences in effective-ness by presentation method could lie in a third variable.Nevertheless, our results only support the effectiveness oflive intervention.

In line with previous reports, no significant moderatoreffect was found for surgery type.6Suggestive interven-tions had the same effectiveness for decreasing anxietyand nausea in minor and major surgeries. However,according to the sensitivity analysis, suggestions wereonly effective for managing pain in minor procedures.Major surgeries involve more effective analgesics com-pared to minor surgeries because they inflict more post-operative pain.19Thus, it is possible that effects in major

procedures are masked by the rigorous analgesic proto-cols. It is also possible that pain management techniquesused in suggestive interventions are less effective in casesof severe pain.

Another important question is how do suggestivetechniques compare in effectiveness to other adjunct non-pharmacological interventions. Early studies found smallto large effect sizes for preoperative interventions suchas patient education, behavioral instructions, relaxation,and cognitive interventions for reducing postoperativeside effects such as pain, psychological distress, and anal-gesic consumption.3,20,21 In contrast, several studies aremore reserved in their reporting, concluding that there

is no sufficient evidence to support the beneficial effectof these interventions.2226 Similarly, the earliest studiesreported very large effects for suggestive techniques4;however, effect size estimates became increasingly tem-

pered throughout the years,57 and based on our results,we now argue that the evidence is not yet strong enough tomake precise estimates of effectiveness. Additional studiesare needed in both fields before a meaningful comparisonof efficacy can be made.

Treatment effect of the interventions could be influencedby a number of additional moderators such as the numberof intervention sessions, customization of the interventionto individual needs, the experience level of the surgeonand the hypnotherapist, the level of procedure-related fearand anxiety of the patient, or the presence and amount ofanxiolytic medication used. There are several possible mod-erators specific to suggestive techniques as well such as

the number of repetitions of suggestions, positive versusnegative phrasing of suggestions, specific suggestive tech-niques used, or the patients susceptibility to suggestions.Information on these factors is generally absent from previ-ous research reports. A possible direction for future stud-ies could be to assess the importance of these moderators,or at least to report relevant data to enable later systematiccomparisons.

LIMITATIONSThe present study has a number of limitations. A largeportion of the studies did not report baseline statisticsfor the outcome measures; thus, only between-group

Figure 5.Effects of suggestive techniqueson postoperative nausea. The effect isexpressed as corrected Hedges g withassociated 99% confidence intervals(CIs). Black squares show the point esti-mates of the effect of individual studieswith horizontal lines corresponding to 99%CIs. The white diamonds (subtotal) repre-sent the pooled estimates and 99% CIsfor each subgroup, and the black diamond(total) shows the pooled estimates and99% CI for all studies. The sample sizes ofthe suggestion (N sg) and control groups(N cg) of each study and the heterogene-ity scores for each subgroup analysis arealso displayed.



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comparisons were used in the analysis. Access to within-subjects data could have led to more accurate estimationof effect sizes. The meta-regressions also indicated thateffects on anxiety might be biased by inappropriate ran-dom sequence generation. Because of the overlap between

moderator conditions (e.g., studies with hypnosis induc-tion were typically presented live, while therapeutic sug-gestions were mostly presented from recordings), theeffects of live presentation and formal hypnosis are dif-ficult to distinguish. The majority of the included studies

Figure 6.Moderator and sensitivity analyses for all outcomes. The effect is expressed as corrected Hedges gwith associated 99% confi-dence intervals (CIs). Black squares (Therapeutic suggestions or Hypnosis), discs (Recorded or Live presentation), and triangles (Minor orMajor surgery) show the point estimates of the pooled effects of studies with the same moderating factor with horizontal lines correspondingto 99% CIs.

Figure 7.Summary graph of risk of biasassessment results.



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used single-blind design (no blinding of participants) andpassive control conditions (i.e., regular treatment) thatmight have resulted in a bias favoring the intervention

because of expectancy effects. Furthermore, 16 of the 139studies selected for detailed full text assessment couldnot be retrieved. We also have to keep in mind that ourresults only apply to the selected outcomes and cannot begeneralized. Clinically relevant outcome measures differ

between procedures, and there is a possibility that someof the suggestive interventions were tailored to addressthese specific issues (e.g., the main aim of the intervention

in the study of Szevernyi et al.27was to reduce bleedingduring orthopedic surgery).

The novelty of the present study is that it included asystematic search for both therapeutic suggestion inter-ventions and hypnosis. This way we were able to drawconclusions on suggestive interventions in general andaddress the difference between hypnosis and therapeu-tic suggestions in particular. Our results indicate thatsuggestive interventions might help surgical patients tocope with postoperative anxiety and pain; however, theevidence is inconclusive, mainly because of the risk of

bias originating from methodological factors. For thera-peutic purposes, we encourage the use of suggestions

with hypnosis induction and face-to-face presentation toalleviate postoperative anxiety and pain. Further stud-ies are needed with proper randomization, allocation,and blinding with sensitivity to within-subjects changesand incorporating rare combinations of moderatorfactors (e.g., recorded hypnosis, live suggestions duringand after surgery and during general anesthesia, etc.).We also encourage researchers to publish full-lengthsuggestion scripts used in their studies either as anappendix or as an online supplement so that possiblesuggestion-specific moderators of effectiveness can beevaluated.E

DISCLOSURESName:Zoltn Kekecs, PhD.Contribution:This author helped design the study, conduct thestudy, analyze the data, and write the manuscript.Attestation:Zoltn Kekecs has seen the original study data,reviewed the analysis of the data, approved the final manu-script, and is the author responsible for archiving the studyfiles.Conflicts of Interest:One of the papers (Kekecs, et al., 201428)included in the review is a work of the first authors (ZoltnKekecs).Name:Tams Nagy, MA.Contribution:This author helped design the study, conduct thestudy, analyze the data, and write the manuscript.

Attestation: Tams Nagy has seen the original study data,reviewed the analysis of the data, and approved the finalmanuscript.Conflicts of Interest: This author declares no conflicts ofinterest.Name:Katalin Varga, PhD.Contribution:This author helped design the study and writethe manuscript.Attestation:Katalin Varga has seen the original study data andapproved the final manuscript.Conflicts of Interest: Two of the papers (Szevernyi, et al.,201227; Kekecs, et al., 201428) included in the review are worksof the third authors (Katalin Varga).This manuscript was handled by:Franklin Dexter, MD, PhD.

Figure 8.Results of risk of bias assessment for each study.



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ACKNOWLEDGMENTS

The authors express their warmest gratitude to Klra Horvthand the library staff of Etvs Lornd University, Budapest,for the help they provided in retrieving the papers included

in the review. The authors are also grateful to Dr. Carlton A.Evans for his invaluable feedback on a previous version of themanuscript. The authors also thank the contacted authors fortheir cooperation in sharing details and data of their studies.

Table 2. Meta-Regressions with Risk of Bias Factors as ModeratorsModel component Estimate SE z P 95%CI lower 95%CI upper

Anxiety

Intercept 0.41 0.33 1.22 0.828 0.25 1.06

Random sequence generation 0.69 0.28 2.48 0.018* 0.14 1.23

Allocation concealment 0.51 0.35 1.45 0.154 0.18 1.20

Blinding personnel 0.62 0.33 1.88 0.058 1.26 0.03

Blinding outcome assessment 0.13 0.32 0.39 0.642 0.50 0.75

Incomplete outcome data 0.27 0.27 1.02 0.304 0.81 0.26

Selective reporting 0.40 0.33 1.19 0.240 1.05 0.26

Pain

Intercept 0.02 0.69 0.03 >0.999 1.32 1.37

Random sequence generation 0.13 0.36 0.36 0.678 0.58 0.85





Selective reporting 0.09 0.47 0.18 >0.999 0.83 1.00

Pain medicationa

Intercept 0.32 0.68 0.47 0.490 1.66 1.01





Incomplete outcome data 0.27 0.46 0.59 0.596 1.18 0.63Nauseab

Intercept 0.18 0.43 0.41 >0.999 0.66 1.01



Blinding personnel 0.91 0.24 3.84 0.003* 1.38 0.45


CI = confidence interval.aAll of the studies in the Pain medication dataset had Unclear risk of bias rating on Selective reporting.bAll of the studies in the Nausea dataset had Unclear risk of bias rating on Blinding of outcome assessment and Selective reporting.

*P< 0.05.

Table 3. General Effects of Suggestive Interventions and Effects of Risk of Bias, Imprecise Inference andSpecial Care

Pooled effect size, Lower and upper bounds and Z test Heterogeneity Moderator effect

Database involved Mean

g

SE Z P 99%CI

lower

99%CI

upper

k I2 H2 z P

Anxiety (all studies) 0.40 0.10 3.90


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kekecs - the effectiveness of suggestive techniques in reducing post-operative side-effects

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