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RANDOMIZED CONTROLLED TRIAL

Assessment of the effect of combined multimedia and verbal information vs verbal information alone on anxiety levels before bond-up in adolescent orthodontic patients: A single-center randomized controlled trial
Jemnique Pal Kaur Srai,a Aviva Petrie,b Fiona S. Ryan,c and Susan J. Cunninghamd London, United Kingdom

Introduction: Despite the high prevalence of dental anxiety in children, there is little research examining anxiety before orthodontic procedures. This parallel-group randomized controlled trial assessed whether provision of additional multimedia information regarding the bond-up procedure affected anxiety in adolescent orthodontic patients. The effects of sex, ethnicity, and age were also investigated. Methods: Participants were recruited from the orthodontic department of the Eastman Dental Hospital, University College London Hospitals Foundation Trust, in the United Kingdom; all were 10 to 16 years of age, with no history of orthodontic treatment, and patient assent and parental consent were obtained. The participants were randomized into control (n 5 45) and intervention (n 5 45) groups using a random number table. Both groups were given verbal information regarding the bond-up procedure, and the intervention group was additionally given a DVD showing a bondup. Anxiety was assessed in the department immediately before the bond-up using the State-Trait Anxiety Inventory for Children, with state anxiety as the primary outcome measure. The researchers were unaware of group allocations while enrolling patients, scoring questionnaires, and analyzing data. Results: A statistically significant difference was found between groups, with a difference in scores of 2 (95% confidence interval for the difference 5 0.15 to 3.85). The median state anxiety was 32 in the control group (n 5 42) and 30 in the intervention group (n 5 43; P 5 0.012). Sex, ethnicity, and age did not significantly affect anxiety. No harmful effects were noted. Conclusions: Additional information reduces anxiety levels, but other methods could be more costeffective than the DVD. Sex, ethnicity, and age did not statistically affect the anxiety levels. (Am J Orthod Dentofacial Orthop 2013;144:505-11)

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a b c

ental anxiety is a complex subjective emotion with many influencing factors: eg, age, sex, socioeconomic group, parental dental anxiety, and previous dental attendance and experiences. Studies show conflicting evidence with regard to the effects of

Specialist Registrar, Eastman Dental Institute, University College London. Biostatistics, Eastman Dental Institute, University College London. Consultant, Eastman Dental Hospital, University College London Hospitals Foundation Trust. d Professor, Orthodontic Department, Eastman Dental Institute, University College London. All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest, and none were reported. Reprint requests to: Susan J. Cunningham, Orthodontic Department, University College London Eastman Dental Institute, 256 Gray's Inn Rd, London, WC1X 8LD, United Kingdom; e-mail, s.cunningham@ucl.ac.uk. Submitted, March 2013; revised and accepted, June 2013. 0889-5406/$36.00 Copyright Ó 2013 by the American Association of Orthodontists. http://dx.doi.org/10.1016/j.ajodo.2013.06.013

these factors on anxiety.1-7 This is understandable when one considers the methodologic difficulties for researchers and the fact that it is not possible to objectively assess a patient's own experience. Thus, patients must be relied upon to self-assess their anxiety; this introduces the possibility of reporting or recall bias. Recall bias can be reduced through the use of prospective trials; however, the assessment of an emotional response is complex. Several self-assessment tools have been developed for use in research into dental anxiety, but some are specific to general dental procedures (ie, restorative work or extractions); naturally, these do not apply to orthodontics. Dental anxiety in children and adolescents is common and well documented, with direct repercussions on the care sought and received by patients.1 Despite the acknowledgment of the high prevalence of dental anxiety, there is currently little research examining
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and the University College London Hospitals Foundation Trust Research and Development Department granted research and development approval. this was appraised and edited until the researchers were satisfied that the DVD was as informative. and succinct as possible. headgear) concurrently. Since these were only opened once written consent and assent had been obtained. The aim of this study was to ascertain whether the additional preparatory information regarding the orthodontic bond-up procedure reduces anxiety in adolescent orthodontic patients. parental consent was also obtained. ethnicity. Patients in the intervention group were also given a DVD created specifically for this study and containing additional information regarding the bond-up procedure. and (2) sex. sealed opaque envelopes containing information relating to the allocations were prepared before the study. DVD labels were then created to inform viewers that it should play automatically on insertion and to provide a contact e-mail address if they had any problems viewing the content. A trial DVD was created using footage of a colleague who was due to commence fixed appliance treatment and had consented to the filming of the bond-up for this purpose. The null hypotheses for this study were the following: (1) the provision of additional multimedia information regarding the orthodontic bond-up procedure does not affect the median anxiety score in adolescent orthodontic patients before the procedure. and changes were made to ensure that the explanation was more child friendly and the quality of the DVD footage was improved.8 The majority (87%) of participants in this research project stated that they thought that information in an audiovisual format would be beneficial because it would allow them to see what actually happens. using the State-Trait Anxiety Inventory for Children. ethnicity. London. This footage was edited to remove substantial repetitive scenes of the bond-up procedure because it was agreed that a viewer's interest would not be maintained over a protracted time period. Previous research has suggested that adolescent orthodontic patients are unclear about the process of placing fixed orthodontic appliances and would like more information to reduce their anxiety. The participants were block randomized in groups of 10 to either the control or the intervention group using a random number table. A secondary aim was to establish the influence of patients' sex. including the lack of verbal explanations. October 2013  Vol 144  Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics . just before the bond-up. and use of computer-generated models rather than a patient in some cases.” Once a suitable patient had been identified and consented for the filming of the bondup procedure. This draft was critiqued by the researchers. Patients were excluded if they had a history of previous orthodontic treatment or were receiving other orthodontic interventions (eg. Verbal information regarding the bond-up procedure was provided by the treating orthodontist to the participants in both groups. with allocation of those with odd numbers to the control group and those with even numbers to the intervention group. a second draft of the DVD was created. and age on anxiety before the bond-up procedure. The footage was therefore edited until the DVD lasted 15 minutes. Anxiety was assessed on the day of the procedure. most were “homemade. It was also agreed that the patient shown in the video of the bond-up procedure should be in the same age group as those recruited for this study to allow effective “modeling. and age do not influence the median anxiety score before the orthodontic bond-up procedure. followed by video footage of a patient having fixed appliances placed. The reason for undertaking this study was therefore to examine the effect of additional multimedia information provision on anxiety levels in adolescent orthodontic patients before the bond-up procedure. To reduce bias. They were 10 to 16 years old and were due to undergo fixed appliance treatment and able to give assent. MATERIAL AND METHODS Ethical approval was obtained from the National Research and Ethics Service (reference number 11/LO/ 0392).506 Srai et al anxiety levels before orthodontic procedures and methods for reducing it. engaging. A number of videos concerning placement of fixed appliances were available. University College London Hospitals Foundation Trust. Again. A DVD was therefore created specifically for this study. United Kingdom. The researchers remained blinded to group allocations when scoring the questionnaires and entering data into the results spreadsheet. according to the department's usual practice.” but some were commercial. However. This was a prospective parallel-group randomized controlled study in which patients were allocated into either the control or the intervention group. the researchers were not aware of the patient's allocation while obtaining consent. poor visibility of the actual procedure. with an introductory section explaining the components of a fixed appliance and the materials and instruments used during the procedure. An Internet search was undertaken to assess the amount and quality of audiovisual information already available to patients and to establish whether any preexisting videos were suitable for use in this study.9 The patients for this study were recruited from the orthodontic department at the Eastman Dental Hospital. several issues were noted.

05 and 80% power. A CONSORT flow diagram (Fig) demonstrates the progression of patients in the study. This self-reported questionnaire comprises 2 scales to distinguish between state anxiety and trait anxiety. Ireland) and based on an independent 2-sample t test. Statistical Solutions Ltd. Additionally. and the questionnaire was removed and placed into a file to be scored later. resulting in a recommended sample size of 43 per group. Because information provision regarding a procedure is likely to affect anticipatory anxiety rather than the stable tendency to anxiety. The outcome measure for this study was the patient's anxiety score as measured by the State-Trait Anxiety Inventory for Children. a total of 90. and this might affect the analysis of the effect of information provision on anxiety. it was estimated that 37 participants were required in each group for significance of P \0.10 Since the remaining results were unlikely to be normally distributed. The data were not normally distributed. with control for trait anxiety. for the control and the intervention groups. Univariable linear regression analysis was used to establish the independent effect of age on patient anxiety.0. so a correction factor was applied. Cork. The patients were also asked to record on the outside of the envelope if they were in the intervention group but had not watched the DVD for any reason. trait. American Journal of Orthodontics and Dentofacial Orthopedics October 2013  Vol 144  Issue 4 . and total anxiety scores were compared with the Mann-Whitney U test. The envelope was then returned to the researcher after the bond-up appointment. The researcher provided verbal instructions about how to complete the questionnaire and highlighted the written instructions at the top of the questionnaire. the patients could take the DVD home to watch before the bond-up appointment. the median state. A significance level of 0. The state anxiety scale poses 20 questions. at the orthodontic records or treatment planning appointment). the primary outcome measure was the state anxiety score. Only state anxiety scores were compared because state anxiety scores had greater importance in this study. immediately before their appointment. but these relate to how the subject usually feels. thus assessing each patient's relatively stable tendency to anxiety. a multivariable linear regression analysis was used to assess the group effect. The assumptions underlying the regression analyses were checked by a study of the residuals and found to be satisfied. NY). Each questionnaire had the patient's unique identification number on the front page. no scenarios are provided in this questionnaire. A 1-sample t test was used for this comparison because the only normative values were mean values.0. The standard deviation of the state anxiety scores was 6. it was decided that 45 participants should be recruited per group: ie. and the patient was asked to seal the completed questionnaire inside and return it to the orthodontist or the reception staff.Srai et al 507 The DVD was provided only to patients in the intervention group once written consent had been obtained and the group allocation had been checked.05 was used for all hypothesis tests.0 points. This test was also used to investigate the effect of sex and ethnicity on anxiety.S. asking how respondents feel at that particular moment in time. The outside of the envelope was checked for any notes before it was discarded. The trait anxiety scale also asks 20 questions. Therefore. It was thought that there might be a relationship between a patient's underlying stable trait anxiety and how he or she reacts to stressful situations. thus assessing transitory anxiety states. This.11 To allow for dropouts from the study.0. makes it applicable for use in most medical and dental settings and ideal for this orthodontic study. a sample-size calculation was carried out using data from the first 10 questionnaires returned from each group. It was hoped that this method of collecting the questionnaires would reduce responder bias in patients who might have felt compelled to complete the questionnaire by selecting answers they perceived to be correct in the researcher's eyes. and the clinically relevant difference in state anxiety scores was set at 4. it was probable that a Mann-Whitney U test would be used. The questionnaire was distributed to the patients by a researcher (J. IBM SPSS Statistics for Windows. Armonk. Using nQuery Advisor (version 4. it was hoped that this assurance of anonymity would reduce any anxiety that the patients might feel if the completed questionnaire was visible to both researchers and clinicians whom they might expect to judge them on their responses. An envelope was provided. To investigate differences between the control and the intervention groups. All analyses were performed using SPSS software (version 21.P.) on the day of the bond-up procedure. along with the fact that it was created specifically to measure anxiety in children and adolescents.K. Because this was done before the bond-up date (eg. RESULTS The participants were recruited between November 2011 and May 2012.9 Unlike some dental anxiety measurement tools. Because there were no studies in the orthodontic literature with the same version of the State-Trait Anxiety Inventory for Children questionnaire. 85 questionnaires were returned by December 2012. The mean state anxiety scores of both the male and female participants in this study were also compared with the normative values provided in the state-trait anxiety inventory for children manual.

October 2013  Vol 144  Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics . The baseline demographics for the patients who completed the questionnaire are shown in Table I. patient declined treatment n=1] Follow-up [change in treatment plan n=2. A statistically significant difference of 2 points (95% confidence interval [CI] for difference.020. CONSORT flow diagram of participants in the study. and the reasons included a change in treatment plan (n 5 3). with participants in the intervention group showing lower state anxiety scores (P 5 0.85) was found in the median state anxiety scores between the groups. as lost to follow-up Fig. No significant difference was found for trait or total anxiety scores between the 2 groups. and treatment declined (n 5 1). Five patients were lost to follow-up. There were no significant sex or ethnicity effects and no significant correlation between age and state anxiety as assessed with the Spearman rank correlation test.508 Srai et al Assessed for elegibility (n = 92) Enrolment Excluded (n = 2) Randomised (n= 90) (declined to participate) Allocation Control group (n = 45) Intervention group (n = 45) Lost to follow-up (n = 3) Lost to follow-up (n = 2) [change in treatment plan n=1. The effect of group allocation on anxiety scores before bond-up is shown in Table II. indicating that only 18.187. However. as lost to follow-up (n = 43 ) Excluded from analysis n = 2.001 and P 5 0.7% of the state anxiety score was affected by the trait anxiety score and the group allocation. Analysis was carried out per protocol. The multivariable linear regression to assess the group effect.15-3.012). 85 returned to have fixed appliances placed and completed the questionnaire. 0. having controlled for trait anxiety. poor oral hygiene resulting in discharge (n 5 1). the adjusted R2 value for this analysis was 0. patient discharged n=1] Analysis (n = 42) Excluded from analysis n = 3. this was deemed appropriate because there were only minor losses to follow-up. indicated that both trait anxiety and group allocation had significant effects on state anxiety scores (P \0. Of the 90 patients recruited. respectively) (Table III).

9) 13 No harmful effects were found at any point while conducting this study. The DVD was specifically created for this research. and we should therefore continue to aim to reduce patient anxiety levels in an orthodontic setting. Multivariable linear regression analysis to assess the effect of underlying trait anxiety and group allocation on state anxiety 95% CI for B Independent variable Trait anxiety Group Regression coefficient B 0.012.Srai et al 509 Table I. 0. n (%) White Other races Median age (y) Table II. the DVD does not appear to have reduced state anxiety below expected normative levels.580 Upper 0. Analysis of mean state anxiety scores for the research group compared with normative values from the state trait anxiety inventory for children manual Sex Female Male Study group compared with normative values Control Intervention Control Intervention P value 0. and the group was entered just before data analysis. n (%) Male Female Ethnicity. Relationship between median anxiety score and group Control group Intervention group (n 5 42) (n 5 43) Median Median score Range score State anxiety subscale 32 38 30 Trait anxiety subscale 30 30 30 Total anxiety 61 59 58 P Range value 22 0. but it also included information requested by patients in a previous study in our department.001 0. both the control and the intervention groups had state anxiety scores similar to normative data (Table IV).034 Lower 0.8 The DVD was viewed and critiqued by orthodontic experts. The median state anxiety levels in the intervention group were 2 points lower than those in the control group.012 30 0. The state anxiety scores for the patients in this study did not differ significantly from the normative values.850 39 0.31 0. These results are shown in Table IV. Additionally. this could potentially introduce bias. all of them thought that the final version met the requirements for this study. A sample size calculation was carried out to ensure that the study had sufficient power.15-3. the patient filmed in the DVD. the researchers scored the questionnaires and entered these data into the spreadsheet with no knowledge of the patients' groups. The findings showed that before the bond-up. The study results are therefore statistically robust and allow conclusions to be drawn.08 0. Most clinicians would like their patients to be less anxious when they are due to undergo the bond-up procedure than they would be for a school examination.393 À3.51 0.0) 57 (67.0) 51 (60.020 Table IV. The questionnaire was distributed by the researchers.599 À0. this ensured that the information provided encompassed what the researchers thought was important. Baseline demographics of the patients who completed questionnaires Group Control (no DVD) (n 5 42) 18 24 28 14 13 Intervention (DVD) (n 5 43) 16 27 29 14 13 Total population (n 5 85) 34 (40. a difference that was statistically significant (P 5 0. No significant difference was found between the 2 groups for either trait or total American Journal of Orthodontics and Dentofacial Orthopedics October 2013  Vol 144  Issue 4 . 95% CI for the difference.160 Table III.07 A 1-sample t test was carried out to allow comparison of the state anxiety of the study population with the mean normative values for the State-Trait Anxiety Inventory for Children. This comparison therefore suggests that attending a bond-up seems to have a similar effect on anxiety as does a school examination. This indicates that viewing the DVD before bond-up reduced state anxiety.1) 28 (32. DISCUSSION Demographic Sex. and her parents. because the researchers met the patients only once. However. The authors of the questionnaire collected mean normative values for state anxiety by asking the children to imagine that they were about to sit for an academic school examination. a retrospective power calculation was undertaken on the data from the 85 questionnaires returned and showed that the 80% power required had still been obtained.85) (Table II). colleagues. It was intended that these measures would minimize bias.187 À5. In view of the loss of 5 patients. the likelihood of remembering the patient's group allocation when distributing the questionnaire was low.489 P value \0.

The 95% CIs for state anxiety (À0. Milsom KM. Buchannan K. Harker R.1 who found that girls had twice the odds of being dentally anxious than boys. 3. although perhaps not at clinically relevant levels. This was to be expected because the DVD only provided information regarding the bond-up procedure. the regression analysis showed that the DVD led to a 3. Morris J. the state anxiety score increased on average by 0.489 to À5. 2011. there might have been a greater positive effect on anxiety reduction. illustrate the overall positive effect of the DVD. although the difference was significant. This significant reduction in anxiety contrasted with results from previous studies examining the effect of information in a printed leaflet.001). Unlike the self-reported questionnaire used in our study. the first null hypothesis can be rejected. Marwinski G. A prospective study of dental anxiety in a cohort of children followed from 5 to 9 years of age. Accessed October 8. regardless of the intervention. Clin Oral Invest 2006.pdf. The possibility that patients with a tendency to higher trait anxiety scores might experience higher state anxiety scores was also considered. Chestnutt I. 2005. Children’s Dental Health in the United Kingdom.36:857-60. Patients with a tendency toward higher levels of trait anxiety had higher levels of state anxiety. Int J Paediatr Dent 2009.580 points was feasible. Clinicians could then use information leaflets to direct patients to reliable videos placed on such sites. Jones C. London.7% of the state anxiety score was affected by the trait anxiety score and the group allocation. Morris J. J€ ohren P. ethnicity. few previous studies with which to compare these findings. October 2013  Vol 144  Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics . this was significant (P \0. Tickle M. each patient's needs must be assessed individually. and any information provided should be tailored accordingly. however.034 points was still below the clinically relevant difference. This highlights the multidimensional nature of anxiety as previously noted by Newton and Buck. United Kingdom: Office for National Statistics. It might be worth considering giving DVDs to those with the greatest likelihood of anxiety. Chadwick B. be viable to give patients the information in a way that would cost less. because it allowed patients to see a real-time video of the procedure they would undergo.393 points.15 It is unsurprising then that Klingberg and Broberg16 concluded that research into anxiety is fraught with methodologic and conceptual problems. Children's dental anxiety in the United Kingdom in 2003. Even though the results showed no significant association between anxiety and age. Lader D. Tickle et al used a parent-reported questionnaire. in state anxiety. et al. or ethnicity.dh. This might reduce patients' anxiety in a more cost-effective manner. Nuttal N. Dental anxiety in a representative sample of residents of a large German city. Gilbert A. Humphris GM. and a reduction in state anxiety of up to 5. this contrasts with a prospective cohort study by Tickle et al. Enkling N. 2003.034-point reduction. This demonstrates that some patients will experience a clinically relevant reduction in anxiety and confirms the potential benefits of providing this type of information. Blinkhorn AS. it might not be justifiable to routinely distribute a DVD in a clinic or a practice to reduce anxiety. REFERENCES 1. The adjusted R2 value indicated that only 18.510 Srai et al anxiety levels. The regression analysis showed that for every 1 point of increase in trait anxiety. and it should therefore affect only a participant's anticipatory anxiety. YouTube) or allowed to play in a clinic waiting room. It might be beneficial to provide additional audiovisual information more cost-effectively: eg. Therefore. and further work is required.gov. 4. it was less than the clinically relevant difference of 4 points used for the sample size calculation. and age did not statistically affect anxiety levels before bond-up. however. However. however. the footage from the DVD could be put on social media sites (eg. sex. The results also indicated no statistically significant difference between white patients and those of other races and no significant correlation between anxiety and age.580 points). however.19:225-32. as with most clinical decisions. Available at: http://www. Given the limited reduction in anxiety and the costs involved. This finding was significant. CONCLUSIONS The results of this study showed that the provision of additional information regarding the bond-up procedure does significantly reduce state anxiety levels on average. The provision of this information on social media sites might have certain benefits when compared with playing the video in a clinical waiting area because it would allow patients to watch the video as many times as they would like and in a more relaxed environment.uk/prod_consum_dh/groups/dh_digitalassets/ @dh/@en/documents/digitalasset/dh_4107310. Having accounted for the effect of the underlying trait anxiety.12-14 It is possible that the audiovisual format was seen as more interactive. on average. 2. It might. Nuttall NM. J Dent 2008. on social media sites or in clinical waiting rooms. Summary Report Office for National Statistics. There are. and this was accounted for by undertaking a multivariable regression analysis (Table III). the average reduction of 3. Anxiety was not significantly affected by sex. Sex. but there was no evidence to reject the second hypothesis based on our results.10:84-91.

1973. Who's afraid of informed consent? Br Med J 1993. Olumide F.childrensmercy. 14.aspx.Srai et al 511 5. J Am Dent Assoc 2000. 9. Sutcliffe P. Newton JT. Woods TO. Anxiety and pain measures in dentistry: a guide to their quality and application. Nor en JG.17:391-406. 15. Accessed September 23. Klingberg G. Thevasagayam RS. McConnachie J.com/products-page/nquery-advisor-sample-size-software/. 10. Lushene R. Broberg AG.19:338-42. Palo Alto. Swed Dent J Suppl 1997.80:329-35. Gilbert DB.2:17-24.statistical-solutionssoftware. 131:1449-57.103: 405-12. Children’s dental health in Europe: an epidemiological investigation of 5. Int J Paediatr Dent 2007.306:298-300. Spielberger CD. et al.122:1-88. 2011. Child dental fear: cause-related factors and clinical effects. Thomas WE.and 14-year old Scottish children. Sharma PK. Bolin AK. McWelch I. 11. Carlsson SG. Shorthouse AJ. motivation and compliance in early orthodontic treatment. Ryan FS. The prevalence of dental anxiety in a group of 13. Eur J Oral Sci 1995. Klingberg G. 8. American Journal of Orthodontics and Dentofacial Orthopedics October 2013  Vol 144  Issue 4 . Gorsuch RL. Anticipatory anxiety in children visiting the dentist: lack of effect of preparatory information. Berggren U. Kerrigan DD. 7. Int J Paediatr Dent 1992. Accessed September 23. 16. Am J Orthod Dentofacial Orthop 2013. Int J Paediatr Dent 2009. Preliminary test manual for the state-trait anxiety inventory for children. Influence of supplemental written information on adolescent anxiety. Jacobs GA. Available at: http://www. Newton JT. Fleming PS. Dental fear/anxiety and dental behaviour management problems in children and adolescents: a review of prevalence and concomitant psychological factors. 2011. Dunne S. Information seeking behavior in adolescent orthodontic patients. 13. Stephens RM. Donnan PT. Available at: http://www. Childrens-Mercy. Battagel J. Vagg PR. 12. Calif: Consulting Psychologists Press. Cunningham SJ. Angle Orthod 2010. Wright NS. org/stats/size/mann. Bedi R.and 12-year old children in eight EU countries.com. nQueryAdvisor.143:303-9. Buck DJ. 6.