Effect of the bubble breath exercise on behaviour,anxiety and pain during injection anaesthetic in children: a randomized clinical trial

Phase 1/2

Completed

• Conditions: Healthy human volunteers tested to see whether or not relaxation training exercise is helpful in reducing anxiety and pain perception

• Registration Number: CTRI/2018/10/016188
• Lead Sponsor: Sowmya Sridhar

Brief Summary

The sight and sensation of the anaesthetic needle is the most fear-eliciting stimuli in children receiving dental treatment. Children trained on the bubble breath exercise perceived lesser pain while administering buccal infiltration anaesthesia. There was no significant change in the behaviour and anxiety.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-05
• Study Completion: 2018-10-05
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Children in general good systemic health.
• Written informed consent from the parents.
• Dental treatment required under maxillary buccal infiltration anaesthesia.

Exclusion Criteria

• History of previous unpleasant dental experience involving local anaesthetic administration.
• Children who present with acute pain or require emergency dental treatment under local anaesthesia.
• Children suffering from any illness requiring special medical care.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Facial image Scale and Pulse oximetry- Anxiety	Facial image scale- pre-procedure in the first and second appointment; Behaviour and Pain assessed in second appointment 3 days after first visit
Frankls behaviour rating scale- behaviour during the injection	Facial image scale- pre-procedure in the first and second appointment; Behaviour and Pain assessed in second appointment 3 days after first visit
Wong-Baker FACES scale and FLACC scale- Pain	Facial image scale- pre-procedure in the first and second appointment; Behaviour and Pain assessed in second appointment 3 days after first visit

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not applicable

Trial Locations

Locations (1)

Manipal College of Dental Sciences, Mangalore; 🇮🇳 Kannada, KARNATAKA, India

Manipal College of Dental Sciences, Mangalore

🇮🇳Kannada, KARNATAKA, India

Sowmya Sridhar

Principal investigator

9900660452

sowsri06@yahoo.co.in