跳至主要内容
临床试验/CTRI/2025/02/080471
CTRI/2025/02/080471招募中不适用

the effect of box breathing exercise on anxiety during administration of buccal infiltration in children aged 6 to 10 years.

Self College of dental sciences and research centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Dental Anxiety

研究概览

简要总结

Dental procedures, especially local anesthetic administration, are a source of great anxiety to children. Breathing exercises have been proposed as an effective intervention to improve subjective well-being and manage anxiety symptoms. As they are comparatively easy to learn and to implement, breathing exercises may be particularly beneficial for children. Box breathing or square breathing involves inhaling, holding the breath, exhaling and again holding the breath for 4 counts. It forms the box pattern with the breath.

  Aim:

The aim of this study is to evaluate immediate effects of Box breathing exercise on anxious children before and after administration on Buccal infiltration.

children between age range of 6-10 years who require bilateral buccal infiltration local anesthesia for dental treatment will be randomly selected.

Inclusion Criteria:  good physical health, have no previous experience with breathing exercises for anxiety relief, should be nasal breathers and show mild to moderate anxiety levels according to RMS.

Exclusion Criteria: Children with severe anxiety, or cognitive impairments that may hinder participation, mouth breathers.

Informed Consent and Ethical Approval- taken.

The children will be administered buccal infiltration local anesthesia in the first session. After an interval period of 1 week, on the second session, the children will be taught box breathing exercise just prior to administration of buccal infiltration local anesthesia on the contralateral side.

Dental anxiety, dental pain and child’s behaviour assessed

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • good physical health, Requiring bilateral infiltration, should be nasal breathers, show mild to moderate anxiety levels according to RMS, Frankl’s behaviour rating-2,3.

排除标准

  • Children with severe anxiety uncooperative behaviour or cognitive impairments that may hinder participation mouth breathers.

结局指标

主要结局

Dental Anxiety

时间窗: at baseline,immediately after box breathing exercise

Dental Pain

时间窗: at baseline,immediately after box breathing exercise

次要结局

  • cooperation or behaviour(at baseline, immediately after box breathing exercise)

研究者

发起方
Self College of dental sciences and research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Harsha Kewlani

College of Dental sciences and research centre, Bopal

研究点 (1)

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