Comparative evaluation of anxiety reduction in children undergoing endodontic and exodontia procedures with or without the use of binaural beats: A split mouth randomized controlled trial

Comparative evaluation of anxiety reduction in children undergoing endodontic and exodontia procedures with or without the use of binaural beats: A Split mouth Randomized Controlled Trial

Anxiety is a human emotion involving behavioural, effective, and cognitive responses to the perception against unknown. The knowledge and understanding of anxiety laid the foundation of Paediatric dental professional’s ability to provide the best possible care for children and establish a healthy and long-term relationship with them.1,2 The child attaining a dental operatory primarily go through emotions like separation from parents, confronting unfamiliar people/environments and fear of pain.3 There are many risk factors in development of child’s dental anxiety and fear as it has multifactorial etiology. The emotional status of child, cognitive abilities, age, gender, stories heard from other sources, parental anxiety and previous painful experience are considered to evoke anxiety and fear in children. Fears are usually mild, age-specific, and can go away as age increases. In children, fear of dental procedures leads to deterioration of oral hygiene as it causes avoidance of dental treatment due to hindrance in behaviour management.4,5 To overcome this, various pharmacological and nonpharmacological techniques are used. Non-invasive nonpharmacological management techniques are always preferred as they help avoiding adverse effects associated with the use of drugs and also the discomfort associated with invasive modalities like general anaesthesia, sedation.6 Listening music is one such nonpharmaceutical interventions as it is relatively inexpensive and easily available. Audio analgesia in the form of live music, familiar songs, calm sounds, and white noise has been previously utilized with satisfactory results in a reduction of anxiety and subsequently increased pain threshold in patients. Although simple and effective, the conventional audio analgesia modalities relied mostly on the principle of distraction and thus, posed with certain limitations.7 Binaural beats, first described by Dove in 1939, occur when two sounds with steady intensities but different frequencies are presented separately, one to each ear. The resulting perception in the brain equals the difference between them requiring a collective action of both ears. For example, when a frequency of 130 Hz tone is presented to the left ear and a 132 Hz tone to the right, a beat of 2 Hz is perceived in the brain. Binaural beats act “centrally”, i.e., the binaural beat percept being the result of the effect of a central interaction which most likely occurs in the superior olivary nuclei. They are only subjectively perceived when two sine waves of nearby frequencies are delivered to each ear separately. Brainstem neurons in the Superior olivary nucleus, which are sensitive to phase shifts between both ears, fire action potentials at a rate corresponding to the phase difference between both ears and generate the binaural-beat percept. Thus, the binaural-beat percept is caused by the major neural mechanism which enables sound localization. Binaural beats at various sound frequencies have been used to treat many disorders and to induce various psychological states including pain, relaxation, meditation and anxiety as well as to enhance vigilance and memory.8,9 Overall, binaural beats provide additive benefits of conventional distraction audio analgesia along with brainwave entrainment which forms its primary scientific principle. Brainwave entrainment waves are widely used for relaxation in conjugation with meditation or yoga, and their use in dental clinics has also been attempted.8 The present study will be conducted with the objective of further understanding and validating the clinical effectiveness of binaural beats in the reduction of anxiety in paediatric patients during endodontic and exodontia procedures

The study is intended to evaluate effectiveness of binaural beats in children undergoing endodontic and exodontia procedure. Study design: It is a split mouth, randomized controlled in vivo clinical study. Study setting: Study will be carried out in the Department of Paediatric and Preventive Dentistry of the Dental College. Study population: The study sample will comprise of paediatric patients of age ranging from 6-12 years undergoing endodontic and exodontia procedures. Methods of Data Collection: After obtaining appropriate permissions from the Scientific Advisory Committee and Institutional Ethical Committee, data collection procedure will be carried out. Sample size: The sample size was calculated using Openepi software (v3.0) at 95% confidence interval and 80% power in reference the study conducted by Jafarimofrad S et al. The formula for the same is: N = (σ1 2 + σ2 2 / κ) (Z1 – α /2 + Z1 – β) / Δ2 The notation for the formulae: N = sample size σ 1 = standard deviation of Group 1 σ 2 = standard deviation of Group 2 Δ = difference in group means Κ = ratio = 1 Z1 – α /2 = two-sided Z value (ex. Z=1.96 for 95% confidence interval). Z1 – β = power N= (0.53 x 0.53) + (0.54 x 0.54) (1.96 +0 .84)2 / (0.63 x 0.63) = 12 The calculated sample size 12 samples per group There are 4 groups. The sample size= 12 x 4 = 48 Page | 13 The total sample size is 48. Sampling technique and blinding: Simple Randomized sampling for the side of patients undergoing endodontic or exodontia procedures. It will be single blinded study. To select the right or left quadrant of the maxilla or mandible for treatment, the closed envelope technique will be used. For this purpose, 48 envelopes will be prepared; half of them will contain a paper with the code 0 and the remaining half will contain a paper with the code 1. Code 0 will indicate the left quadrant and Code 1 will indicate the right quadrant. The other quadrant will be treated in the next session. Half of the children will be provided with binaural beats in first session and the remaining half will be provided with binaural beats during contralateral dental procedure. Method of selection of study subject: INCLUSION CRITERIA:

1. Patients in the age group of 6-12 years presenting to department of paediatric dentistry.
2. Patients with bilateral cases of endodontic therapy or bilateral cases of exodontia.
3. Genetically and systemically healthy children. EXCLUSION CRITERIA:
4. Medically/physically handicapped children ex. Epileptic, autistic, etc.
5. Patients/parents who have not signed the consent form.
6. Children with auditory deficit.
7. Children under the influence of CNS altering drugs. Study material: • Suitable binaural beat generating software and hardware Study armamentarium: • Syringe loaded with Local anaesthesia • 24gauge needle Page | 14 • Wireless Headphones • Smartphone

Study groups: experimental group and control group 24 children in each group

Procedure: In this randomized, controlled, split-mouth, clinical trial, 12 healthy children with age range 6-12 years requiring endodontic therapy and 12 healthy children with age range 6-12 years requiring extraction, will be selected. The patients, parents/guardians will be explained about complete procedure and will be allowed to listen to the type of audio that will be presented to the patient following which written consent will be obtained. A brief medical as well as dental history will be recorded. Pure readymade binaural beats of two different suitable frequencies will be played with a software compatible with smart phone and will be used in patients belonging to experimental group. Page | 15 The anxiety level of the patient will be assessed using MCDASf (Faces version Modified Child Dental Anxiety Scale) which consists of 7-8 questions which will be filled by the patients.

The anxiety will also be assessed by the parent with the help of CFSSD (Dental Subscale of the Children’s Fear Survey Schedule)

An observer will assess the patient with the help of Sound Eye Motor Scale

Objective symptoms will be assessed with the help of pulse oximeter and BP apparatus. This procedure will be followed by both the control and experimental group. The patients during the treatment of experimental side will be presented with pure binaural beats, using wireless headphones and those in the control side will be presented with no sound. The volume of sound provided will be below 75 decibles. Patient will be allowed to control the volume in case of discomfort. Anxiety assessment will be done after 15 mins of presentation of sound in case of extraction and 45 mins after presentation of sound in case of endodontic therapy by the above mentioned anxiety scales

Statistical analysis: Statistical analysis will be done with appropriate statistical software at 95% Confidence interval and 80% power to the study. Descriptive statistics was performed in terms of mean, standard deviation. Intergroup and intragroup comparison will be done using qualitative analysis tests. Statistical significance will be calculated at p<0.05.

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