Koleoso ON, Osionwo HO, Akkhigbe. The role of relaxation therapy and cranial electrotherapy stimulation in the management of dental anxiety in Nigeria. ISOR Journal of Dental and Medical Sciences. 2013; 10(4): 51-57. 

Device
Alpha-Stim®

Key Variable
Dental Anxiety

Objective
The purpose of this study was to assess the therapeutic efficacy of 3 treatment modalities for the treatment of dental anxiety: relaxation therapy (REL), cranial electrotherapy stimulation (CES), and a combination treatment of relaxation therapy and CES.

Design
This was an IRB approved study that used a randomized, quasi-experimental research design that had pre-post measures.

Primary Effectiveness Endpoint
The primary effectiveness endpoint was the change from baseline in the post-treatment scores on the Modified Dental Anxiety Scale (MDAS) among the 4 groups (the 3 treatment groups and the control group) at the endpoint of the study.

Key Inclusion Criteria
• Male or female subjects ≥ 18 years old.
• Subjects who were experiencing oral pain conditions for at least 3 months.
• Pain was due to identifiable physical oral pathology and verified by a dentist.
• Subjects had high anxiety scores of ≥ 14.25 on MDAS.

Key Exclusion Criteria
• Pregnancy, planning to become pregnant or nursing.
• Presence of implanted pacemakers, pumps or electrical stimulators.
• Facial pain.
• Acute oral pain less than three months.
• Psychogenic oral pain.
• Pain due to oral cancer.
• Traumatic injures associated with oral pain.
• Individuals with gross mental abnormality or other diagnosable neurological disorders.

Protocol Summary
Respondents who reported high dental anxiety (≥ 14.25) and who agreed to come for the therapeutic interventions for the next 3 days were randomly assigned to 1 of 4 groups based on the order in which they arrived back at the psychological assessment room after they had been treated by the dentist; relaxation therapy group, CES treatment group, both treatments simultaneously group and the no treatment control group. During the relaxation therapy session, subjects listened to 30 minutes of relaxation training that was played on an MP-3 audio recorder via head phones. Subjects in the combined relaxation and CES treatment group did a 45 minute CES treatment while listening to the relaxation instructions. Subjects in the CES treatment group completed a 45 minute CES treatment. Treatment sessions for all subjects took place in the same room between 9 AM to 12 noon each day. After the three days of treatment, subjects returned to the Dental Centre the following Monday to complete the MDAS.

Device Application Protocol
The Alpha-Stim CES unit was used for CES treatments. The device was set at 0.5 Hz and the current was increased until the subject felt “light-headed” and then decreased “to their comfort level.” The length of treatment was 45 minutes. Each subject had one individual meeting with the lead investigator during the 3 days

Outcome Measures
The Modified Dental Anxiety Scale (MDAS) was used to measure dental anxiety symptoms. A study by Humphris et al. (2009) confirmed the “high” reliability and validity of the MDAS.

Results

Subjects
One hundred thirty-eight (138) potential subjects reported high anxiety on the MDAS. Of these 40 respondents agreed to participate and completed the study. The primary reasons given for not participating in the study was inadequate time, cancelled appointments or did not live in the city where the study was conducted.

Baseline Measurements Potential subjects had to score ≥ 14.25 on the MDAS indicating high dental anxiety in order to be accepted into the study. Their screening score was used as the baseline measure.

Data Analysis
One-way ANOVA was used to compare mean dental anxiety scores across the 4 groups. The t-test for independent samples was used to compare the mean scores of dental anxiety at pre-test and post-test. Descriptive statistics and reliability assessment (Cronbach alpha and split-half method), and post hoc Scheffe’s test were also used.

Dental Anxiety
The CES group means (M=10.20), the relaxation group (M=10.70) and the combined treatment group (M=9.40) had significantly lower dental anxiety (p<0.01) than the control group (M=18.30) at the endpoint of the study as seen in Figure 1. Each of the 3 treatments significantly decreased dental anxiety (p <0.05) from pre-test to post-test. There was no statistically significant difference among the treatment groups on dental anxiety. Based on the findings of this study, CES was as effective at decreasing dental anxiety as relaxation therapy and the combined treatment group. However CES is easier to use compared to learning relaxation techniques.

Figure 1. Mean dental anxiety scores by group at the end of the study.
CES=active group, RELAXATION=relaxation instruction group, CES+REL=combined group.

Quality of the Research
Strengths of this clinical study are: the use of a randomized quasi-experimental research design that had pre-post measures; the use of a valid and reliable scale (MDAS); and the cut-off score for dental anxiety on the MDAS in this study was established in a previous pilot study. Limitations are: the small N, there were 10 subjects in each of the 4 groups; and a lack of standardization of CES treatments as they were individualized for each subject. The finding of this study that CES significantly decreases dental anxiety, is as effective in decreasing anxiety as relaxation, and is easier to use than learning relaxation techniques is consistent with previous findings by Gibson et al, in 1987. The finding that CES significantly decreases anxiety is also consistent with the other Alpha-Stim CES anxiety studies in the literature that found CES significantly decreases anxiety.

Author Affiliations
Koleoso, ON. Department of Mental Health, University of Benin Teaching Hospital, Benin City, Nigeria; Osinowo, HO. Department of Psychology, University of Ibadan, Ibadan, Nigeria; Akhigbe, KO. Department of Mental Health, University of Benin Teaching Hospital, Benin City, Nigeria.

References

Gibson, Thomas H. and O’Hair, Donald E. Cranial application of low level transcranial electrotherapy vs. relaxation instruction in anxious patients. American Journal of Electromedicine, 4(1):18-21, 1987

Humphris GM, Dyer TA, Robinson PG. The modified dental anxiety scale: UK general public population norms in 2008 with further psychometrics and effects of age. BMC Oral Health. 2009 Aug 26; 9:20.