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J Am Dent Assoc, Vol 139, No 3, 317-324.
© 2008 American Dental Association |
RESEARCH |
A Randomized Controlled Clinical Trial
| ABSTRACT |
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Methods. This prospective randomized controlled study compares a brief relaxation method (BR) with music distraction (MD) and with a control group (C). The authors randomly assigned 90 patients with dental anxiety to BR, MD or C groups. They assessed the outcomes by means of the state anxiety subscale of the State-Trait Anxiety Inventory.
Results. Both BR and MD reduced dental anxiety significantly. In contrast, patients in the C group did not exhibit a significant change in their anxiety level. BR was significantly superior to MD. Stratification according to the patients general level of dental anxiety revealed that BR also was particularly effective in highly anxious subjects, whereas MD did not have a clinically relevant effect on these subjects.
Conclusions. BR appears to be a safe, economically sound and effective nonpharmacological approach to the short-term reduction of dental anxiety. Additional investigations are needed to validate these findings in a larger clinical trial and to determine the long-term effects of this intervention.
Clinical Implications. Relaxation techniques are a pragmatic, effective and cost-saving method of facilitating dental treatment in anxious patients.
Key Words: Dental anxiety; complementary medicine; randomized controlled clinical trials
Abbreviations: BR: Brief relaxation. C: Control. DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, 4th edition. HAQ: Hierarchical Anxiety Questionnaire. MD: Music distraction. STAI: State-Trait Anxiety Inventory. STAI-S: State-Trait Anxiety Inventory-State. STAI-T: State-Trait Anxiety Inventory-Trait.
Dental anxiety is a significant problem for patients and dental care providers. Patients who have dental anxiety tend to avoid necessary treatment, and once in the dental chair, they often are difficult to treat. Misdiagnosis may even result from a dentist-patient relationship that is dominated by severe anxiety.1
Avoidance of dental treatment owing to anxiety is common and appears to be associated strongly with significant deterioration of oral and dental health,2 leading to a vicious cycle of cumulative anxiety and increasing avoidance.3 Enkling and colleagues4 conducted a demographic survey and found that 11 percent of a German community sample experienced dental anxiety. While a survey of Norwegian subjects reported a prevalence of dental anxiety below 10 percent,5 other studies have reported that the prevalence of high levels of dental anxiety ranged between 4 percent6,7 and more than 20 percent.6,8 Dental anxiety levels tend to be higher in female patients9,10 and seem to decrease with age, although it is not yet clear if this effect is due to aging itself or to a cohort effect reflecting differences between age clusters surveyed in the trials.11
Development of dental anxiety usually is associated with a traumatic experience in connection with dental treatment,12,13 but many additional causes also are known. The theory of model learning (that is, learning processes resulting from observing the behavior of role models such as family members) and stories told by people in everyday surroundings are considered to have an influence on the emergence and development of different degrees of dental anxiety.14
Several studies support the hypothesis that pain or fear of pain is a primary source of anxiety, as well as a major obstacle to seeking dental care.15 In addition, highly anxious patients appear to be more sensitive to pain.16,17 Accordingly, Wardle18 found the dental injection to be most powerful as an anxiety-provoking stimulus, followed by the dental drill. However, beyond memories that subjects have regarding their dental experiences in childhood, the level of dental anxiety clearly is influenced by individual psycho-pathologic traits, as well as by the patterns of interpersonal attachments that affect patients therapeutic alliance to their dentist.14
Effective treatment options include an explanation of the treatment procedure,19 pharmacological strategies involving the use of benzodiazepines and antidepressants,20 biofeedback,21 hypnosis22 and behavioral interventions.23 Behavioral management seems to be superior to anxiolytic drug therapy,24 and dentally anxious patients reported that they prefer nonpharmacological interventions.25 Most of the behaviorally oriented treatments include components based on systematic desensitization23 and use of relaxation to counteract and weaken the fear response during gradual exposure to treatment.
Berggren and colleagues26 conducted a study in which training in progressive muscular relaxation led to a greater reduction in anxiety among dentally anxious patients than did a cognitive approach. A possible explanation for this is that the perception of personal control as achieved with applied relaxation is a clinically important factor that influences patients level of acute pain, which is known to be a primary source of dental anxiety during stressful dental procedures.27 Thus, the question arises whether interventions aimed at patients psychophysiological arousal, such as relaxation techniques, result in effects that are different from those achieved with approaches that involve more passive distraction from the anxiety-provoking stimuli.
The aim of our study was to test the hypothesis that an isolated short intervention involving the use of a brief relaxation (BR) technique is effective and superior to music distraction (MD), a supportive technique used commonly in dental practice28,29 for the treatment of dental anxiety. We compared BR with MD and with a control group (C), which did not receive any treatment for dental anxiety.
Owing to the naturalistic design of the study and our use of self-reported dental anxiety as an inclusion criterion, this study did not fulfill the diagnostic criteria for dental phobia as a specific phobia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition30 (DSM-IV). Therefore, we did not define a cutoff point for the psychometric measurements or require a typical behavioral pattern of a patient with a dental phobia (that is, delaying, canceling or failing to appear at dental appointments).
The dentist (R.S.) asked potential subjects to participate in this clinical trial, and he explained that they would be randomized into one of two treatment groups (BR or MD) or into the C group. Of the 92 patients asked, 90 agreed to participate; three of these subjects were lost to follow-up owing to missing questionnaires. We obtained written informed consent from all subjects. We randomized participants in a 1:1:1 ratio to the BR, MD or C groups. A study nurse carried out the randomization confidentially. We concealed the allocation by using randomized numbers generated by an electronic spreadsheet created before the study.
The duration of the trial was identical for all three conditions. During the first appointment, subjects underwent regular dental diagnostic procedures, and the dentist (R.S.) informed them of necessary treatment steps. Because of the study design, all subjects had simple caries that was not in an advanced stage. Classification as simple caries implied that we could expect restorative treatment to be completed in a single session, which was the case for all participants.
At the second appointment (which took place within 14 days of the first appointment) subjects completed two questionnaires (State-Trait Anxiety Inventory [STAI],31 Hierarchical Anxiety Questionnaire [HAQ]32). The dentist then explained BR and MD. While we used MD as a passive relaxation technique during dental treatment, we introduced BR to subjects in a 10-minute training session, accompanied by brief written instructions, before administering it during treatment (Box
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SUBJECTS, MATERIALS AND METHODS
TOP
ABSTRACT
SUBJECTS, MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSION
REFERENCES
Sample and study procedure.
We recruited participants over a six-month period in a community dental clinic in a rural area of Germany. After an initial office visit, we included in the study regular clinic patients who needed dental treatment and acknowledged their dental anxiety. Exclusion criteria were age younger than 18 years, severe somatic or psychiatric disease, and use of any psychoactive medication (such as an antidepressant or a tranquilizer), as well as a foreseeable need for complex dental treatment requiring more than one treatment session.
33). Immediately after the completion of dental treatment and before the final consultation with the dentist, subjects again completed the STAI.31
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Treatment. BR. We used the method of functional relaxation, because this technique is effective not only as a regular treatment for various psychosomatic disorders, but studies have proven its effectiveness as a brief, single intervention.33,35
Functional relaxation is used commonly in Germany, Austria and Switzerland for the treatment of a variety of psychosomatic disorders through positive stimulation of the autonomic nervous system36 and the discovery of proprioception. Patients perform minute movements of small joints during relaxed expiration while focusing on perceived changes in bodily feelings triggered by the movements. In this way, subjects place importance on their relationship to the floor or to some other external foundation (that is, outer support), to the bony skeleton (referred to in functional relaxation as "the frame") (inner support) and to the interior regions of the body and skin (the latter being the outer border separating the body from ones environment).37
The dentist provided subjects in the BR group with short written instructions regarding BR in the waiting room before dental treatment. In addition, immediately before administering dental treatment, he explained the method to patients in the BR group. If necessary, the dentist explained the process further during treatment. To minimize any effects other than those resulting from BR, we urged the dentist to avoid talking continuously with the patient during the appointment.
A psychosomatic specialist (T.L.) trained the dentist in the functional relaxation technique in a 10-session course. The dentists proficiency was ensured via supervised treatment sessions conducted with patients who were not part of this study. Moreover, we ensured adherence to the technique via continuous supervision during the trial (by videotaping the treatment sessions).
MD. MD is a noninvasive technique in which the user listens to pleasant music during a stressful procedure. It is based on a widely held perception that in a dental setting, music can reduce pain and anxiety, which are linked closely and lead to mutual amplification.38 MD is successful not only among pediatric39,40 and adult dental patients,41 but also in other medical settings, such as intensive care42 and oncology.43 Patients themselves have evaluated the utility of supportive MD highly.44 The effect of MD is believed to be a combination of relaxation and distraction.45
We gave participants a list of various music styles from which to choose. During dental treatment, they listened to the music through headphones, with volume control at their discretion. The dentist ensured a pleasurable experience by periodically asking participants if they would like to change the music. Consequently, the nonspecific effect of the dentists conversing with the patient during treatment was similar to that with BR.
Questionnaires. Subjects in this study completed the STAI31 and HAQ,32 both of which were self-administered tests. The primary outcome parameter was the state subscale (STAI-S), because it was the only questionnaire administered before and after treatment. Participants completed the questionnaires independently, and a study nurse checked the data for completeness.
STAI.
The STAI31 is a well-known and widely used instrument for detecting different types of anxiety. The instrument consists of two scales, each with 20 questions (total scores range from 20 to 80, with higher scores indicating higher levels of anxiety). The STAI-S measures the subjects current level of anxiety, while the trait scale (STAI-T) assesses his or her general tendency to experience anxiety. The internal consistency31 of the STAI-S and STAI-T (Cronbach
) is r = .77 and r = .90, respectively. According to Moore and colleagues,46 the state subscale is a useful measure for detecting fluctuating dental anxiety.
HAQ. We used the HAQ32 to stratify the intensity of dental anxiety. The questionnaire addresses six anxiety-provoking situations associated with dental treatment. It consists of 11 questions assessed on a five-point scale ranging from "nonanxious" to "completely anxious." On the basis of an overall score ranging from 11 to 55, we can categorize respondents into "low anxious" (up to 30), "moderately anxious" (31 to 38) and "highly anxious" (above 38) groups.45 The HAQ is validated sufficiently3,32 and exhibits a high correlation (.88) with Corahs dental anxiety scale.47 Because the HAQ was developed to measure dental anxiety as a consistent characteristic, we administered it only once (before the intervention).
Ethical considerations. We planned and conducted this study in accordance with the Declaration of Helsinki and ethical laws pertaining to the medical profession. The ethics committee of the University of Regensburg Medical School, Germany, approved the trial design, and we obtained written informed consent from subjects. We conducted the study independently of any institutional influence, and it was not funded.
Statistical analysis. Because the data were not normally distributed, we used the Mann-Whitney test as an appropriate nonparametric method to compare each treatment group with the C group and the BR and MD treatment groups with each other.48 We used standard deviations and probability to report treatment results according to the principles of an explorative data analysis. Owing to the explorative approach, we did not carry out a post hoc Bonferroni correction of the level of significance despite the multiple testing. We analyzed the data using statistical software (SPSS, version 12.0, SPSS, Chicago).
| RESULTS |
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error of .05 and a power of .80.
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| DISCUSSION |
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One potential explanation for the greater efficacy of BR, aside from the intended decrease in physiological arousal, lies in the subjects experience of a typically anxiety-producing situation that otherwise is controlled almost exclusively by the dentist. To a certain extent, the subject is able to control his or her own perception of stress, thereby achieving reduced pain sensitivity.49 These factors do not apply to MD, which operates on a principle of overall distraction by masking fear-enhancing noises during treatment.
Single interventions. In contrast to more complex psychotherapeutic strategies, our study showed that both BR and MD were effective as single interventions without requiring prior training of participants. This is especially important for BR, which is an active technique that the user has to learn, in contrast to the passive MD intervention. The written instructions we gave subjects are similar to a manual used for a single BR intervention, which has proven to be effective in other somatic and psychosomatic conditions, such as asthma33,35 and tension headache.50 A 10-session intervention with BR also has been effective in somatoform heart disorders.37
With respect to our investigation, the study design itself might suggest that anxiety reduction can be brought about by termination of dental treatment as an anxiety-provoking stimulus. This might explain the decrease in state anxiety in the C group. However, a counterargument to this is the fact that we observed only marginal anxiety reduction in the C group in comparison with the BR and MD groups. This may be due to the highly elevated and thereby long-lasting state anxiety level before and during dental treatment, which does not subside rapidly on its own.
Study limitations. It is important to state that most of the participants in this study did not have a dental phobia, defined by DSM-IV as a specific phobia, because they visited the dentist regularly and came to the dental clinic voluntarily. Therefore, our inclusion criterion was neither avoidance behavior (the main criterion for a specific phobia in DSM-IV) nor a certain level of anxiety, according to the HAQ or STAI-S. Rather, subjects reported their subjective experience of dental anxiety spontaneously. Therefore, it is not surprising that the mean (± standard deviation) HAQ score of 28.7 (± 9.3) for our study sample is close to the level of dental anxiety (28.8 ± 10.1) reported in a German community sample.4 De Jongh and colleagues51 conducted a literature search, the results of which suggested that relaxation alone would not be the appropriate intervention for subjects with severe dental phobia. For these subjects, more comprehensive strategies, including exposure therapy or other cognitive-behavioral techniques, would be needed.
We also need to point out that we did not measure the dentists oral communication (a nonspecific therapeutic variable), which might have been slightly more intense with subjects in the BR group. However, because no subject reported difficulties implementing BR, there is no indication that more intense conversation between the dentist and the patient is needed with BR.
Despite a valid power calculation, the sample size was relatively small; thus, our findings are of a preliminary nature.
| CONCLUSION |
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| FOOTNOTES |
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| REFERENCES |
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This article has been cited by other articles:
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C. Lahmann, T. H. Loew, K. Tritt, and M. Nickel Efficacy of Functional Relaxation and Patient Education in the Treatment of Somatoform Heart Disorders: A Randomized, Controlled Clinical Investigation Psychosomatics, September 1, 2008; 49(5): 378 - 385. [Abstract] [Full Text] [PDF] |
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