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BRIEF COMMUNICATION

The Awareness of Being Observed Changes the Patient’s Psychological Well-being in Anesthesia

Donatella De Amici, MD^*, Catherine Klersy, MD^*, Felice Ramajoli, MD, and Loretta Brustia, MD

Departments of *Epidemiology and Clinical Biometry-Scientific Direction and Anesthesiology and Intensive Care, IRCCS Policlinico San Matteo, Pavia, Italy

Address correspondence and reprint requests to Dr. Donatella De Amici, MD, Department of Epidemiology and Clinical Biometry-Scientific Direction, IRCCS Policlinico San Matteo, Piazzale Golgi, 2, 27100 Pavia, Italy. Address e-mail to ddeamici{at}smatteo.pv.it

	Introduction

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Many anesthesiologists realize that patients who perceive themselves to be the target of particular interest and attention change their behavior. This change, a result of the awareness of being under observation, is called the "Hawthorne effect" (1). Moreover, it was shown more than 30 yr ago that the meeting between patient and anesthetist and the type of information given can influence postoperative morbidity (2,3), although contradictory studies were published later (4–9).

The aim of our study was to show the presence of the Hawthorne effect in routine anesthesiology practice and to quantify it in terms of psychological well-being (primary endpoint) and other signs and symptoms.

	Methods

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We designed a randomized, clinical study, which was approved by the local ethical committee, to assess the influence of "being under observation" on patient’s psychological well-being. Patients were randomized either to a "routine information group" or to an "additional information group." Both groups were treated identically in all respects, except for the following sentence included in the informed consent form of the latter group: "We are conducting a research study to evaluate the acceptability of locoregional anesthesia. Therefore, you are part of research and you will be followed with particular attention and interest to record which side effects of anesthesia are least acceptable to you." Patients aged 18 yr and admitted for simple knee arthroscopy between June 1, 1997, and June 30, 1998, were considered for the study. Exclusion criteria were the use of tranquilizers or sedative hypnotics, history of psychiatric disease and the abuse of alcohol or drugs, and the request for general anesthesia.

The primary end point was assessed by means of the Italian version of the General Health Questionnaire (GHQ) (30-item version), an instrument to measure psychological well-being (10). The GHQ is a self-rating questionnaire extensively used to detect nonpsychotic mental disorders. The GHQ-30 was chosen because of its well validated ability to identify individuals with psychological problems in a nonpsychiatric setting and to measure psychological changes and changes in well-being over time in such situations. The GHQ-30 was scored by assigning a score of 0 for each item in the first two response categories and of 1 in the last two (11). The scores obtained for each single item were added for each patient: the lower the total score, the higher the state of well-being.

Secondary end points, such as postoperative pain relief and nausea and headache intensity were quantified by means of a 100-mm visual analog scale (VAS), ranging from "no symptoms" at one end to the "worst possible symptoms" at the other. Scale midpoint (50) was a priori retained as a cutoff. The subjective importance the patient attributed to each of the symptoms was also measured on a VAS, and the sum was computed to assess overall importance of symptoms. The occurrence of vomiting and other problems, if any, were recorded, together with the need for analgesia (both postoperatively and during the following night), the return of spontaneous urination, or the requirement for a urinary catheter. Collection of data involved two anesthetists and was performed twice. The first anesthetist, in charge of the anesthetic procedure, met the patient in a quiet room the day before surgery. The interview lasted approximately 30 min and covered the patient’s history, points of anesthesiological importance, and physical examination; the GHQ questionnaire was then administered before randomization, and the patient was given the informed consent form corresponding to his/her group assignment to the research or the routine care protocol. The second anesthetist examined the patient approximately 7 h after surgery and the following morning. He was blinded as to the patient’s group assignment. During the 7th-hour assessment, he administered the postoperative GHQ and the VAS for symptoms and assessed the presence of signs and symptoms according to protocol.

No sedative hypnotics were given the evening before operation. On the morning of the operation, spinal anesthesia was performed, without premedication, in lateral decubitus with a 27-gauge needle; 0.5–0.8 mL of hyperbaric bupivacaine at 0.5% was injected into the subarachnoid space. The dosage was calculated on the basis of the patient’s height, so that the level of anesthesia reached, but did not go beyond, T12. Acetated Ringer’s solution (1500 mL) was infused rapidly; it was started soon after the institution of spinal anesthesia and continued during the operation, followed by an additional 1000 mL in the postoperative phase. No analgesic or antiemetic treatments were prophylactically administered. Problems related to the anesthetic technique, such as multiple attempts to puncture the dura mater, paresthesis, and bleeding were recorded.

For statistical analysis, the primary end point was a priori dichotomized to separate patients who showed a reduction in their GHQ score from patients who remained stable or worsened. Logistic regression was used to assess the role of the "type of approach" to the patient. Both the raw odds ratio (OR) and the OR controlled for sex, age, education, and symptoms were computed together with their 95% confidence intervals (95% CI). As a confirmation, median regression was performed on raw data to assess the role of the "type of approach" on GHQ change, after controlling for the above mentioned covariates. The stratified estimate of the regression coefficient together with its 95% CI was computed. Data on basal GHQ score, GHQ change, and secondary end points were compared by means of Student’s t-test, or Mann-Whitney U-test for skewed variables, and Fisher’s exact test for continuous and categorical variables, respectively. Accordingly, mean and SD, median and interquartile range (IQR), or frequency were used for data description.

P values < 0.05 were considered statistically significant. Stata 6.0 (StataCorp, College Station, TX) was used for computation.

	Results

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Overall, 116 patients were enrolled, 56 in the routine information group and 60 in the additional information group. Mean age was 30 (SD 7) and 32 (SD 8) yr, respectively, with a male:female ratio of 35:21 and 36:24. High grade education (13 yr) was observed in 53.6% and 43.3% of patients. All patients were ASA physical status I, and no patient had previously undergone spinal anesthesia. Duration of surgery was 45 (SD 6) min. Adequate surgical anesthesia was achieved in all patients. Complete recovery of sensory and motor function was observed in all patients at postanesthesiology examination the evening after the operation, and no patient reported neurologic symptoms, such as dysesthesia or hyperesthesia.

Median baseline GHQ score was computed to 1.0 (IQR 0 to 4.5) in the routine information group and to 2.0 (IQR 0 to 5.0) in the additional information group preoperatively (P = 0.1162). Median postoperative GHQ scores were 0 (0–3) for both groups, and median changes in GHQ scores were computed to 0 (IQR -1.5 to 0) and -1 (IQR -2 to 0), respectively (P = 0.049) (Fig. 1). Well-being increased postoperatively in 43% of patients of the former group and 63% of the latter. Patients of the additional information group had an OR of 2.3 (95% CI 1.1–4.9) and 3.1 (95% CI 1.1–8.6) to have a postoperative increase in well-being compared to patients belonging to the routine information group for the raw and the stratified model, respectively. Median regression provided a further confirmation of these findings with an estimated stratified regression coefficient of 0.73 (95% CI 0.33–1.14; P = 0.001).

View larger version (11K): [in this window] [in a new window]   Figure 1. A decrease in the General Health Questionnaire (GHQ) score corresponds to an increase in quality of life.

	Discussion

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In experimental research, the Hawthorne effect might be the undesired effect of the experiment itself and could invalidate results. In anesthesia practice, owing to the particular emotional condition of a patient facing a surgical operation, the Hawthorne effect could be especially strong and, on the contrary, benefit the patient.

The preoperative phase, when the patient signs the informed consent form, is characterized by tension and apprehension (12,13). The quality and quantity of information on anesthetic care given to the patient are objects of debate: more information would either benefit the patient (2,3,7,8) or increase his/her distress (14–16). We did not address the issue of quality or quantity of information, but we did focus on its emotional impact. Actually, we demonstrated that patients "under observation" increased their psychological well-being after surgery to a higher degree than patients in the control group. This finding was further supported by the minor impact of pain and other signs and symptoms in these patients.

A major limitation of this study relates to the size of the effect that we have elicited, which is indeed small. However our goal was primarily to demonstrate the mere existence of the Hawthorne effect in this clinical field. Furthermore, we feel that its size can be only small, but not negligible. These are preliminary findings and future confirmations are needed.

In conclusion, this study indicates that, given the same information about anesthesia and undesired effects, the particular interest as a result of inclusion in a research project (and the consequent awareness of being under observation) has positive psychological and physiological consequences for the patient. Therefore, devoting particular attention to the patient’s feelings in this particular emotional moment is of paramount importance not only for the quality of anesthesia care but also for the patient’s mental and physical well-being.

	References

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