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Table of Contents   
ORIGINAL RESEARCH  
Year : 2021  |  Volume : 24  |  Issue : 2  |  Page : 209-213
Assessment of yogic relaxation techniques for its anxiolytic effects in patients requiring endodontic treatment: A prospective, randomized controlled study


1 Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai, Maharashtra; Department of Yoga, Sri Sri Institute of Advanced Research, Badamanavarathekaval, Karnataka, India
2 Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai, Maharashtra, India
3 Department of Pharmacology, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai, Maharashtra, India

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Date of Submission21-Feb-2021
Date of Decision15-Jun-2021
Date of Acceptance15-Jun-2021
Date of Web Publication09-Oct-2021
 

   Abstract 


Background: The aim of the study is to assess the anxiolytic effects of yogic relaxation technique (YRT) in patients requiring root canal treatment (RCT).
Materials and Methods: In this prospective, randomized, placebo-controlled study, 30 patients undergoing RCT with baseline visual analog scale for anxiety (VAS-A) of score >4 were divided into Group 1: YRTs; Group 2: alprazolam (0.25 mg/0.5 mg), and Group 3: placebo. After 30 min of completion of YRT, endodontic treatment was performed. Reduction in anxiety was analyzed using state anxiety score (domain) of the state-trait anxiety inventory scale.
Results: There was no significant difference in anxiety score 1 h before RCT between groups (P = 0.401). Ten minutes before (P < 0.0001) and after RCT (P < 0.0001), there was significant difference between groups (yogic relaxation vs. alprazolam [P < 0.0001]; yogic relaxation vs. placebo [P < 0.0001]). Ten minutes before RCT, yoga relaxation showed significant difference in anxiety score for pain versus alprazolam and placebo (P < 0.0001 for both). Ten minutes after RCT, the change from baseline in mean anxiety score for pain was significantly different with yogic relaxation (versus alprazolam [P = 0.043]; versus placebo [P = 0.002]). As per the global assessment of efficacy, the response was excellent in 9 (90%), 2 (20%), and 1 (10%) patients in yoga relaxation group, alprazolam group, and placebo group, respectively. Difference in response between three groups was significant (P < 0.0001). There was no significant difference in the global assessment of tolerability between three groups (P = 0.535). No adverse events were reported.
Conclusion: Before RCT, YRT is an effective alternative to anxiolytic agents, alprazolam.

Keywords: Anxiolytic effect; root canal treatment; yoga relaxation technique

How to cite this article:
Verma MR, Rao RD, Langade D, Jain AK, Guha A, Mohan M. Assessment of yogic relaxation techniques for its anxiolytic effects in patients requiring endodontic treatment: A prospective, randomized controlled study. J Conserv Dent 2021;24:209-13

How to cite this URL:
Verma MR, Rao RD, Langade D, Jain AK, Guha A, Mohan M. Assessment of yogic relaxation techniques for its anxiolytic effects in patients requiring endodontic treatment: A prospective, randomized controlled study. J Conserv Dent [serial online] 2021 [cited 2021 Nov 30];24:209-13. Available from: https://www.jcd.org.in/text.asp?2021/24/2/209/327853



   Introduction Top


Anxiety is an unpleasant emotion and may cause patients to avoid a planned operation.[1]

Fear is a common problem among dental patients attending endodontic clinics.[2] A questionnaire-based study reported root canal therapy and oral surgery treatment to be associated with high anxiety, whereas other procedures, i.e., crown, dentures, and fillings, were rated to be associated with moderate anxiety.[3] Stress induced by endodontic treatment (ET) can affect heart rate and blood pressure of the patient.[4] Reduction of anxiety before surgical and nonsurgical root canal treatment (RCT) is important as stress may insidiously affect both the healing process and the patient's adaptability to cope with further care.[4] Patient- and treatment-related factors have influence on anxiety.[5] Pharmacological and nonpharmacological options are used by clinicians to alleviate anxiety of patients. Yoga and meditation work on all aspects of the person: physical, vital, mental, emotional, psychic, and spiritual. It provides complete harmonization of the body and helps reduce stress and anxiety.[5] Yoga nidra and relaxation music has been shown to help in reducing pain among patients undergoing colonoscopy.[6] Thus, nonpharmacological therapy in yoga is an easy and alternative option for reducing stress and anxiety.[7],[8],[9] To the best of our knowledge, there are no published data yet comparing the anxiolytic effects of yoga versus medication in patients requiring RCT.

It has been suggested that different pathways may be adopted by people from different ethnicities, suggesting the need for individualized strategies for the management of anxiety associated with RCT.[10]

The objective of this study was to assess efficacy of Yogic Relaxation Techniques (YRTs) for its anxiolytic effects in patients requiring RCT.


   Materials and Methods Top


This prospective, randomized, placebo-controlled study (the study was registered at Clinical Trials Registry of India - CTRI/2014/09/004968) was initiated after approval of the institutional ethics committee.

Patients between 18 and 50 years of age of both gender attending outpatient department of conservative dentistry and endodontics undergoing dental procedure for the first time, requiring RCT with a diagnosis of symptomatic irreversible pulpitis for any teeth and a baseline visual analog scale for anxiety (VAS-A),[10],[11] score of >4 were included after obtaining their written informed consent.

Patients with nonvital teeth, history of use of other anxiety drugs, psychoactive drugs or glucocorticoids preceding 1 week, emergency cases, and any condition which could interfere with YRTs, pregnant or lactating women, and patients with other significant systemic illnesses were excluded. Enrolled patients were divided into the following three groups: Group 1: YRTs; Group 2: tablet alprazolam, and Group 3: placebo. They were instructed to have a light meal 1 h before scheduled appointment.

Computer-based predetermined randomization codes (treatment to be given to the patient) were prepared. After assignment of serial number to each patient, sealed envelopes containing the randomization code, i.e., study group, were opened on the scheduled appointment day, after rechecking the VAS-A score of >4. Blinding was not done because of yogic relaxation methods used. Ten minutes before and after RCT, the anxiety assessments and vital parameters were recorded for all groups.

YRT was performed for participants in Group 1, 60 min before the scheduled time of RCT. Relaxation techniques (Bhramari [3 min],[12] Nadi Shodhan Pranayam [5 min],[13] and Panchkosha meditation [recorded version by HH Sri Sri Ravi Shankar (22 min)])[14] were performed in the sequence under supervision of an AYUSH-certified yoga instructor. After 30 min of completion of YRT, RCT was performed.

Participants in Group 2 received oral alprazolam 1 h before the scheduled time of RCT. Under the guidance of a physician (MD, Pharmacology), patients less than or equal to 50 kg body weight received 0.25 mg tablet, whereas those above 50 kg body weight received 0.50 mg tablet.

Participants in Group 3 received 5 mg folic acid 1 h before the scheduled time of RCT. The primary outcome was reduction from baseline in the scores during preoperative period for anxiety using the state domain of the state anxiety score (domain) of the state-trait anxiety inventory (STAI) scale.[15] The secondary outcome measures included reduction from baseline in the scores during preoperative period for anxiety using 0–10 cm VAS-A (0 – no anxiety or fear for the procedure and 10 – severe anxiety and fear for procedure) and change in vital parameters from baseline to the pre- and post-operative period. Global assessment of efficacy of therapy (PGAET) was assessed by the patients using 5-point scale of “excellent, good, moderate, poor, and worst” after completion of RCT. Clinical safety was assessed by recording adverse events. Duration of the study for each participant was 1 day, i.e., the day of RCT.

Statistical analysis

In this exploratory study, 30 participants were enrolled empirically due to lack of previous data. Data of STAI and VAS-A scores are expressed as means with standard deviation. Categorical data and discrete data (global assessments) are expressed as numbers with percentages. Changes from baseline in the STAI and VAS-A scores at pre- and post-operative period were analyzed using one-way analysis of variance (ANOVA) with treatment as the main factor. Post hoc individual comparison was done using Bonferroni's method. Data for vital parameters were analyzed using ANOVA (similar to STAI and VAS-A scores). Data for global assessments between different treatments were compared using Wilcoxon sign-rank test. All tests were performed using two-sided tests at an alpha of 0.05.


   Results Top


The study included 30 patients (ten in each group). Overall, the study population was predominated by female population (20 [66.70%] vs. 10 [33.30%]). Gender-wise, there was no significant difference between three groups (P = 0.549). Similarly, there was no significant difference in mean age, height, or weight between three groups [Table 1].
Table 1: Baseline characteristics of study participants

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Primary efficacy parameter

[Figure 1] shows that there was no significant difference in the mean anxiety score 1 h before RCT between three groups (P = 0.401). However, 10 min before (P < 0.0001) and 10 min after RCT (P < 0.0001), there was significant difference between groups. Post hoc analysis showed significant difference in anxiety score with yogic relaxation as compared to alprazolam (P < 0.0001) and placebo (P < 0.0001) both 10 min before and after RCT.
Figure 1: Mean anxiety scores in three study groups. ET: Endodontic Treatment

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[Figure 2] shows that the percentage change from baseline in anxiety scores was significantly different between groups 10 min before RCT (P < 0.0001) and 10 min after RCT (P = 0.002). Post hoc analysis showed significantly higher reduction in anxiety score with yogic relaxation as compared to alprazolam and placebo 10 min before RCT and 10 min after RCT (vs. alprazolam P = 0.013; vs. placebo P = 0.001).
Figure 2: Percentage change (improvement) in anxiety scores in three study groups. ET: Endodontic Treatment

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Secondary efficacy outcomes

Visual analog scale scores for pain

[Figure 3] shows that there was no significant difference between groups in the mean VAS score for anxiety 1 h before RCT (P = 0.201). Post hoc analysis showed significantly lower VAS score for anxiety 10 min before RCT with yogic relaxation as compared with alprazolam (P = 0.031) and placebo (P = 0.022).
Figure 3: Visual analog scale scores for pain in three study groups. ET: Endodontic Treatment

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[Figure 4] shows that 10 min before RCT, the percentage change from baseline in VAS score for anxiety was significantly different between groups (P = 0.008). Percentage change from baseline in VAS scores for anxiety with yogic relaxation was better as compared to alprazolam (P = 0.036) and placebo (P = 0.003).
Figure 4: Percentage change in visual analog scale scores for pain in three study groups. ET: Endodontic Treatment

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Effect on blood pressure

Mean values of systolic blood pressure (SBP) were not significantly different 1 h before (P = 0.548), 10 min before (P = 0.100), or 10 min after (P = 0.109) RCT. However, the percentage change in SBP between groups was statistically significant 10 min before (P = 0.06) as well as 10 min after (P = 0.032) RCT. Post hoc analysis showed significant difference between YRT and placebo 10 min before (P = 0.002) and 10 min after (P = 0.011) RCT. Difference between YRT and alprazolam was not statistically significant.

For mean diastolic blood pressure (DBP), there was no difference between groups 1 h before (P = 0.877) and 10 min before (P = 0.210) RCT; however, 10 min after RCT, the groups showed statistically significant difference (P = 0.032). Percentage change showed similar results. In post hoc analysis 10 min before RCT, the results were similar to that of SBP. However, 10 min after RCT, the difference was significant only when it was compared with placebo (P = 0.005).

Effect on pulse rate

Mean pulse rate was similar between groups 1 h before (P = 0.206), 10 min before (P = 0.897), and 10 min after (P = 0.790) RCT. Percentage reduction in pulse rate was significantly different between groups 10 min before (P = 0.005) and 10 min after (P = 0.002) RCT. Post hoc analysis showed significantly better percentage reduction in pulse rate 10 min before ET with yogic relaxation as compared with alprazolam (P = 0.040) and placebo (P = 0.001). However, 10 min after ET, the pulse rate of YRT when compared to placebo (P = 0.001) was better than alprazolam (P = 0.732).

Global assessment of efficacy

The global assessment of efficacy is illustrated in [Table 2]. The difference in response between three groups was statistically significant (P < 0.0001).
Table 2: Global assessment of efficacy and tolerability in three study groups

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Tolerability

There was no significant difference in the global assessment of tolerability between three groups (P = 0.535) [Table 2]. Similarly, no adverse events were reported by any of the patients in the three groups.


   Discussion Top


Anxiety in patients with dental problems is commonly encountered. Several options available for the management of anxiety can be broadly divided into pharmacotherapy, nonpharmacological therapy (e.g., music intervention),[16],[17] or combination of two options.[19]

Yoga represents a nonpharmacological and simple approach for the treatment of anxiety in dental patients. Yoga-based lifestyle intervention is beneficial in many health conditions including hypertension,[20] reduction of pain,[6] and stress and anxiety reduction.[17],[18] In this study, we compared effects of YRT versus alprazolam and placebo in relieving anxiety associated with RCT.

Anxiety is common in both male and female patients undergoing ET. The results of our study showed that there were more female participants who had anxiety compared to males. This could be possibly related to gender difference in the prevalence of anxiety. It has been reported that female patients coming for RCT have higher level of anxiety as compared to males.[21]

The age group 18–50 years was selected as anxiety is seen more in this age group.[21]

Our study results are similar to published literature review suggesting benefits of yoga in reducing anxiety and stress.[9] We observed promising role of YRT in alleviation of anxiety in patients undergoing RCT. Yoga therapy in our study showed significantly better improvement in terms of anxiety score as compared to other two groups both 10 min before and after RCT. This suggests that single session of yoga for 30 min before RCT can be significantly effective for reducing stress level. The suggested mechanism being the decrease in conflict between body and mind.[22]

In this study, Nadi Shodhan and Bharamari Pranayama were used. Nadi Shodhan Pranayama balances both the brain hemispheres, while the vibrations of sound of Bhramari Pranayama have a soothing effect on the mind and nervous system.[23] Stress and anxiety causes irregular breathing that disrupts brain rhythms causing physical, emotional, and mental blocks.

Pranayama establishes regular breathing patterns breaking this negative cycle.[23] A pre-recorded Panchakosha-guided meditation by HH Sri Sri Ravi Shankar was used. Meditation clears out repressed mental conflicts and neutralizes the emotions attached to them.[24]

Anxiety is also associated with physical changes in the body, especially on blood pressure and heart rate. Yoga has shown to result in significant decrease in the resting heart rate and blood pressure.[22] In our study, percentage reduction in blood pressure and pulse rate was also favorable with YRT as compared to the other groups. These beneficial effects observed may be attributed to better regulation of sympathetic nervous system and hypothalamic–pituitary–adrenal axis.[25] A cross-sectional study showed low serum cortisol levels among people practicing yoga.[7] In our study, the global assessment of efficacy showed excellent response in more number of patients with YRT as compared to other groups. There were no safety-related concerns in any of the patients in all three groups. None of the treatments were associated with any adverse events. No significant difference was observed in the global assessment of tolerability between three groups. Overall, our results suggest that YRT improves reaction to the stresses induced by RCT and helps in better recovery.

This study is associated with some limitations, namely open-label design for YRT, small number of patients due to lack of previous data, challenges of first time dental experience, and ongoing pandemic. Hence, the results of our study should be carefully extrapolated. Larger studies are required to confirm our observation.


   Conclusion Top


YRT is an effective alternative method for reducing anxiety among patients undergoing RCT. It can be used as an alternative to other pharmacological measures for reducing anxiety in these patients.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

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Correspondence Address:
Dr. Malavika Mohan
Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7 CBD Belapur, Navi Mumbai - 400 614, Maharashtra

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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcd.jcd_97_21

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