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Clinical Trials/CTRI/2022/02/040233
CTRI/2022/02/040233Not yet recruitingNot Applicable

“COMPARATIVE EVALUATION OF ANXIETY LEVELS IN CHILDREN UNDER GOING RESTORATIVE PROCEDURE USING,NO MUSIC, NURSERY RHYMES AND MUSIC OF CHOICE AS A BEHAVIOUR MANAGEMENT TECHNIQUE IN CHILDREN BETWEEN 4-12 YEARS- AN IN VIVO STUDY.â€

Department of Pediatric and Preventive Dentistry1 site in 1 country45 target enrollmentStarted: February 25, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
45
Locations
1
Primary Endpoint
Reduction in anxiety

Study Overview

Brief Summary

A child’s first dental visit is pivotal for reduction of dental anxiety and for success of treatment in future. If this is not managed, it might possibly continue in their adolescence1. Fear and stress are the main factors that cause anxiety in children when they undergo dental treatment. Numerous factors are responsible for these situations, such as dental instruments and equipment and negative experiences of family members from dental treatment. The child’s hesitancy or uncooperative behavior may curb the effective delivery of dental care that may compromise the quality of treatment provided.2

 The role of pediatric dentist in managing an anxious child is not only to control the ailment with which the child reports but also to teach the child appropriate means to manage dental fear. One such non-aversive modality to manage a child appropriately in dental clinic is distraction. The disruptive behavior of few pediatric dental patients’ can be controlled by diverting their attention and engaging them in alternative activities like watching TV, playing video games, or listening to audio taped music. Thus, it enhances child’s effective coping skills for acceptance of dental treatment.3

 Music reduces anxiety through its effect on the autonomic nervous responses which regulates bodily functions such as the heart rate, digestion, respiratory rate and pupillary response. Secondly, the anxiolytic effect of music is achieved through its suppressive action on the sympathetic nervous system, leading to lowered adrenergic activity and fall in neuromuscular arousal.4

Moreover, to avoid the side effects of the various drugs, patients opt for conservative approaches like music therapy which is an effective, non�’invasive and cost�’effective intervention, which decreases anxiety and therefore optimizes the outcome of a medical intervention. The assessment of anxiety will be done using Venham’s picture test, pulse rate will be measured using pulse oximeter during first dental visit.5

 During the literature search we found that no such studies have been conducted where comparison of anxiety levels has been done using nursery rhymes and music of choice of the children vising dental clinic.  In this research, we will be aiming to study the role of music therapy on reducing dental anxiety in patients undergoing restorations, so that various pharmacological methods for reducing anxiety can be avoided.6

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
4.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Children of age group 4-12 years.
  • •Patients visiting dental clinic for the first time.
  • •teeth having caries involving enamel and dentin.
  • •Children who did not underwent dental procedures, impressions, endodontics and surgery.

Exclusion Criteria

  • •Patients below 4 years and above 12 years of age.
  • •Primary molars grossly decayed having spontaneous pain, swelling, abscess, fistula.
  • •Children with special health care needs.
  • •Patients visiting the dental clinic for second time.
  • •Patients/ parents unwilling to participate in the study.

Outcomes

Primary Outcomes

Reduction in anxiety

Time Frame: At baseline and At end of treatment

Secondary Outcomes

  • Reduction in Pulse rate(At baseline and At end of treatment)

Investigators

Sponsor
Department of Pediatric and Preventive Dentistry
Sponsor Class
Research institution and hospital

Study Sites (1)

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