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* From the Division of Pulmonary and Critical Care Medicine, UCSD Medical Center-Thornton Hospital, La Jolla, CA.
Correspondence to: Henri G. Colt, MD, Division of Pulmonary and Critical Care Medicine, UCSD Medical Center-Thornton Hospital, 9310 Campus Point Dr, La Jolla, CA 92037-0975
| Abstract |
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Design: Randomized clinical trial using pretests, posttests, and two groups.
Setting: Pulmonary special-procedures unit of a tertiary-care referral center.
Patients: Sixty adult patients: 30 patients received music during bronchoscopy and 30 control subjects received no music.
Results: The study population had baseline state anxiety levels similar to those previously reported in surgical patients (42.6 ± 13 vs 42.7 ± 14; p value, not significant [NS]) and higher than those reported in normal working adults (42.6 ± 13 vs 34.4 ± 10; p < 0.001). Experimental and control groups were similar in patient and procedure-related characteristics and baseline pre-FFB state and trait anxiety scores. Although trait anxiety scores decreased significantly after the procedure (pooled post-FFB scores of 32.6 ± 10 vs pre-FFB scores of 35.5 ± 11; p < 0.001), no reductions were noted in state anxiety (pooled post-FFB scores of 42.8 ± 13 vs pre-FFB scores of 42.6 ± 13; p value, NS). More importantly, playing music through headphones during FFB did not result in a statistically or clinically significant reduction in either state or trait anxiety when compared to control subjects.
Conclusion: Relaxation music administered through headphones to patients during flexible bronchoscopy does not decrease procedure-related state anxiety.
Key Words: anxiety flexible bronchoscopy music therapy state-trait anxiety
| Introduction |
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In an attempt to reduce stress, improve patient relaxation, and relieve anxiety in patients undergoing outpatient surgery, dental procedures, invasive endoscopic interventions, and hospitalizations, music has been proposed as a safe and inexpensive nonpharmacologic antianxiety intervention.4 5 6 In addition, music has been shown to do the following: (1) reduce the need for sedation during regional anesthesia,7 (2) help to control pain and anxiety in critically ill individuals,8 and (3) improve patient comfort levels during outpatient bronchoscopy (in at least one prospective randomized trial9 ).
In this study, we determined the effects of music on bronchoscopy-related anxiety by using a generally accepted, well-validated instrument for measuring state and trait anxiety.10 We hypothesized the following: (1) music would result in lower state anxiety scores in patients listening to music during FFB than in patients not listening to music, and (2) patients listening to music during FFB would require anxiolytic medications less frequently than patients not listening to music during bronchoscopic procedures.
| Materials and Methods |
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Random Assignment to Treatment Condition
Using a random-numbers table, a collaborator allocated the
patients to either music ("Relax"; Expansion Records;
Manchester, UK) or silence. The music tape consisted of piano
improvisations performed at a tempo of 60 beats/min. The collaborator
maintained a confidential record of assignments and was not otherwise
involved in the study. To avoid introducing patient bias when consent
to act as a research subject was obtained, we informed the patients
that they were participating in a study of bronchoscopy-related
anxiety; that they would be wearing headphones throughout the
procedure, but they would still be able to communicate with the
procedure nurse; and that the bronchoscopist would be unaware of what
the patient was hearing through the headphones.
Investigator Blinding to Treatment Condition
To prevent the bronchoscopist from becoming aware of the
treatment condition by inadvertently visualizing the cassette, all
tapes were color coded. Only the patients, the collaborator providing
the randomly assigned treatment condition, and the nurse assisting
during the procedure were aware of the treatment condition. To further
avoid introducing investigator bias, we instructed patients to avoid
discussing their treatment condition and to avoid nonverbal signals
that could accidentally divulge the treatment condition to the
investigators.
Bronchoscopy
All procedures were performed by one bronchoscopist assisted by
an experienced procedure nurse. After applying topical anesthesia
(tetracaine, 0.45%, aerosolized) to the patient's nasopharynx and
larynx, the nurse inserted the appropriate cassette of music or silence
into a portable tape player. The headphones were put on the patient,
and the volume level was adjusted. Patient reassurance was provided by
specially trained nursing staff before, during, and after each
procedure. In each case, the nurses were able to communicate
effectively with the patient in spite of the headphones. The FFB was
performed using the transnasal route with patients receiving
supplemental oxygen through a face mask. Routine administration of
sedatives or anxiolytics was avoided, but IV midazolam was administered
during FFB if requested by the patient during bronchoscopy, or if
deemed necessary by the bronchoscopist to improve patient comfort and
tolerance of the procedure. In our institution, most bronchoscopies are
performed without premedication other than topical anesthesia.
Measurements
Patient- and procedure-related characteristics were noted to
determine comparability between groups. Procedure-related anxiety was
measured using the State-Trait Anxiety Inventory (STAI) scale within
1 h before performing FFB.10
Instructions pertaining
to this self-administered questionnaire were provided to each patient
by a nurse practitioner specially trained in questionnaire
administration. The nurse practitioner was available to answer
questions while patients completed their questionnaires.
The STAI scale is composed of 40 self-reported measures of state and trait anxiety. The state anxiety scale (state) consists of 20 questions that determine how the respondents "feel right now." The trait anxiety scale (trait) consists of 20 questions that assess how the respondents "generally feel." Each scale is printed on opposite sides of a single-page test form. The state scale is administered first, followed by the trait scale. For each scale, the respondents circle the number on the test form to the right of each statement that best describes the intensity of their feelings. For the state scale, the choices are (1) not at all, (2) somewhat, (3) moderately so, and (4) very much so. For the trait scale, the responses are (1) almost never, (2) sometimes, (3) often, and (4) almost always. It takes approximately 5 to 20 min to respond to all the items. The patients were told to focus on the period of bronchoscopy only while responding to the state scale questionnaire.
The STAI scale was repeated within 1 h after completing the bronchoscopic examination. The confidentiality of responses was ensured using patient-identification numbers. The nurse practitioner was also blinded to the treatment condition. At the end of the study period, the questionnaires were scored by adding the weighted (1 to 4) scores of each item using the directions and scoring key provided in the Manual for the State-Trait Inventory (Form Y). The scores could vary from a minimum of 20 to a maximum of 80. The scoring of the STAI scale was done by an investigator who had no earlier knowledge of the study protocol, and who was also blinded to other patient-related study data. State and trait anxiety scores of patients undergoing FFB were compared with scores historically reported for surgical patients and normal working adults of similar age and gender.10
Statistical Analysis
Demographics and comparability of the treatment and
control groups were assessed using the t test for continuous
variables and the
2 test
for categorical variables with the Yates correction for 2 x 2
comparisons. For interval-level assessments, repeated measures of
variance (paired t tests) with two time periods were
used to assess differences between pre- and postbronchoscopy STAI
scores. Statistical significance was determined at the 0.05 level and
confidence intervals (CIs) were set at 95% probability. Power
calculations were performed to determine the minimum sample size for a
set
(0.05) and SD (set at 10.4, the SD for State Trait Anxiety
Inventory-State (STAI-S) scores of working adults). On
the basis of our knowledge of the literature and of the STAI scale, we
arbitrarily fixed a clinically significant difference in STAI scores at
5. Power calculations determined that a sample size of 60 patients
would provide a power coefficient of 0.96.
| Results |
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Six patients (five in the treatment group and one in the control group) received between 1 and 4 mg of midazolam during FFB. A clinically significant reduction in state anxiety (10.8 points) was noted in this small group compared to patients receiving no sedation (-1.4 points; difference, 12.2; 95% CI, 2.1 to 22.4; t = 2.41; p < 0.02). A reduction in trait anxiety was not observed. Comparative analyses using only the cohort of 54 patients who had not received anxiolytic medication yielded results that were similar to those obtained using the entire study population; no statistically or clinically significant reductions in state anxiety scores (difference, -1.4; 95% CI, -4.6 to 1.8; t = -0.8; p = 0.4) were noted, but a statistically significant decrease in trait anxiety scores after FFB was seen (difference, 3.2; 95% CI, 1.7 to 4.7; t = 4.3; p < 0.001).
Overall, the median baseline trait anxiety score for all of our study patients was 31. To assess potential differences in state anxiety between individuals having either low baseline trait anxiety (< 31) or high baseline trait anxiety (> 31), we stratified patients from each of the treatment and control groups around this median (29 subjects having low baseline trait anxiety scores and 31 subjects having high baseline trait anxiety scores). We found no statistically significant differences between the two groups (Table 4 ).
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| Discussion |
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Results from studies of music therapy on procedure-related anxiety, however, are not readily generalizable. The conclusions of many investigators are weakened by the following: (1) the absence of investigator blinding, (2) the concomitant use of anxiolytic or sedative medications, (3) the presence of confounding variables, (4) the absence of a well-validated measure of anxiety, and (5) frequent reference to patient perceptions of a procedure or difficult-to-control physiologic variables.
We chose, therefore, a randomized, investigator-blinded study design that required the use of the STAI scale as the principle measure of procedure-related anxiety. Although some question its generalizability,22 this questionnaire is a widely used, self-reporting measure of anxiety that has been extensively employed in clinical research and practice.23 24 25 Designed to assess anxiety as an emotional state, the STAI is written at a sixth-grade comprehension level. Its score is based on a sum of weighted responses ranging from a minimum score of 20 to a maximum score of 80, with a score of 80 representing the highest levels of anxiety. State anxiety is believed to be a transitory emotional state that varies in intensity and fluctuates over time.26 Trait anxiety, on the other hand, is believed to be a personality disposition that remains stable over time and, therefore, should not be influenced by situational stress.
We measured anxiety immediately before and within 1 h after FFB, and we did not note a clinically or statistically significant reduction in state anxiety scores. It is unclear why patients, despite having state anxiety scores greater than those of healthy working adults, did not have reduced scores after FFB. Because our study was based on the use of a questionnaire, we did not attempt to measure levels of anxiety during the procedure itself. Such anxiety, potentially manifested by tightening of the jaw muscles, wrinkling of the forehead, or verbal communications of dismay, could have been forgotten by patients after the procedure, or was perhaps relieved by the reassurance provided to patients by the bronchoscopy staff. We took great care in providing patients with clear instructions regarding the state-trait anxiety questionnaire by asking them within 1 h of the procedure to address procedure-related anxiety. Of course, potential factors contributing toward FFB-related anxiety, such as fear of diagnosis or severity of underlying pulmonary symptoms, may actually outweigh the anxieties prompted by the procedure itself. In our patients, the results of bronchoscopy were shared with the patient before discharge from the procedure area and after the STAI questionnaire had been completed. The maintenance of high levels of state anxiety, therefore, may also have been due to the uncertainty of outcome of the procedure at the time the post-FFB state anxiety measure was taken.
Music did not have a favorable effect on state anxiety scores, even though the treatment group included five patients who had received anxiolytic medication. This subgroup had demonstrably reduced state anxiety scores. In fact, all six patients receiving IV midazolam demonstrated clinically significant reductions in state anxiety compared to patients who did not receive medication. It is comforting to note that anxiolysis is in fact achieved with this anxiolytic!
Recent studies9 21 suggest that physicians and procedure assistants are surprisingly incapable of accurately judging by observation alone the subjective experiences of a patient undergoing an invasive procedure. In our study, the bronchoscopist was entirely blinded to the treatment condition. Premedication was administered only if patients seemed to poorly tolerate the procedure (as shown by excessive movement or coughing) or if they requested medication during FFB. Music did not reduce the need for anxiolytic medication. Perhaps delivering music through headphones promoted anxiety so that anxiolytics were warranted in some patients. Great care, however, was taken to ascertain patient comfort with the headphones, regardless of whether the patient was hearing music or silence; effective communication was always ensured between the procedure staff and the patient. During the entire study, none of the patients in either group requested that their headphones be removed.
It is also possible that personal preferences need to be considered when selecting music for patients. To do this, however, would have substantially increased the number of subjects required for the study; in addition, it could have changed the focus of the trial to addressing what type of music is effective, rather than answering the more straightforward question of whether or not music reduces FFB-related state anxiety. Our results prompt us to suggest that such a study is unnecessary; if music is desired, it should be provided in waiting rooms or procedure suites in an attempt to "soften" the atmosphere for both patients and staff, not because it is a questionably effective anxiolytic intervention. In this respect, a recent study27 of ambience music in the GI endoscopy suite showed no effect on anxiety levels.
Results from our study add weight to the previously stated argument28 29 that changes in state anxiety do not depend on whether individuals have high or low trait anxiety. To address this issue, we stratified patients around the median trait anxiety score to classify patients as having either high or low trait anxiety (Table 4) . No statistically significant differences were noted between groups, and no differences were noted after removing the six patients who had received anxiolytic medication from the analysis (data not presented).
We were intrigued by our finding that trait anxiety scores decreased after FFB, although they were not favorably affected by music either. This unexpected reduction can be attributed to a test-taking artifact that results from simply taking the trait anxiety scale a second time. This effect was observed many years ago by Charles Windle with the Taylor Manifest Anxiety Scale, and has been known as the "Windle Effect" (Charles Spielberger, PhD.; Professor Emeritus; November 1998; personal communication).
In conclusion, bronchoscopists should not assume that because patients are quiet, they are not anxious. In fact, if anxiolysis is desired, it can be effectively provided through the supplemental administration of IV medication. Providing patients with music during a flexible bronchoscopy cannot replace a well-intentioned, competent, and attentive procedure staff. Although music may be relaxing and delightful, this "universal language" does not reduce bronchoscopy-related anxiety.
| Footnotes |
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Received for publication September 30, 1998. Accepted for publication March 22, 1999.
| References |
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A. C. Mehta Don't Lose the Forest for the Trees: Satisfaction and Success in Bronchoscopy Am. J. Respir. Crit. Care Med., November 15, 2002; 166(10): 1306 - 1307. [Full Text] [PDF] |
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S.-M. Wang, L. Kulkarni, J. Dolev, and Z. N. Kain Music and Preoperative Anxiety: A Randomized, Controlled Study Anesth. Analg., June 1, 2002; 94(6): 1489 - 1494. [Abstract] [Full Text] [PDF] |
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