Impact of aroma therapy on salivary cortisol levels among children undergoing dental treatment – Randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Effectiveness of aroma therapy in reducing child stress during dental treatment by comparing the salivary cortisol levels and hemodynamic parameters.
研究概览
简要总结
Dental anxiety during treatment has been identified as a major problem in children and is considered an obstacle in rendering quality dental care. In a dental setting, the needles, drilling sounds, smells of cut dentin, and the sensation of high-frequency vibration often precipitate anxiety and can lead to stress. Stress can elevate cortisol levels and can lead to increased anxiety and hemodynamic parameters. Salivary cortisol levels are known to highly correlate with serum cortisol levels and have many advantages such as non-invasive sample collection and a high acceptability among the patients.
To counteract the precipitating factors of anxiety and stress, Psychotherapeutic interventions like communication skills, trust building, Relaxation techniques like deep breathing, muscle relaxation, Behavior-management techniques, and recently, the use of cognitive behavior therapy has been highly successful. Aromatherapy is one such alternative, non-invasive, economical technique in which patients experience pleasant aroma during dental treatment.
The studywill be carried out by the Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal. Before starting the study IRC clearance from Manipal College of Dental Sciences, Manipal, MAHE, and IEC clearance from Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee, Manipal will be taken.
Participants who meet the inclusion criteria will be invited to voluntarily participate in the study and accepted by an informed consent form. Participants will be block-randomized into intervention (aroma therapy) and control (without aroma therapy) groups. The standard of care dental treatment (scaling or restoration) would be performed between 9 am and 12 pm to monitor cortisol levels. The saliva sample will be collected before and after the dental treatment in both groups. For the intervention group, a commercially available automatic air freshener can be set to release Lavender fragrance at intervals ranging from 1-60 minutes, depending on what is pre-determined by the manufacturer.
During the visit, a calibrated examiner records the Hemodynamic parameters like heart rate, systolic and diastolic blood pressure, and oxygen saturation before, during, and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants between the ages of 12 and 15 years old will be included in the study.
- •Children who were Frankle + behavior (children who accept treatment with cautious behavior at times; willing to comply with the dentist and follow the dentist’s direction cooperatively).
- •Children who require a simple dental restoration and scaling will be included.
- •Participants who are willing to give the parental informed consent form and verbal ascent and are willing to participate in the study.
排除标准
- •Patients with asthma, common cold, tonsillar adenoidal enlargement, patients requiring nasal airways, chronic obstructive pulmonary disease, psychiatric diseases, and complex cardiac conditions will be excluded from the study.
- •Participants who are uncooperative during the treatment and not willing to continue the treatment will be excluded.
结局指标
主要结局
Effectiveness of aroma therapy in reducing child stress during dental treatment by comparing the salivary cortisol levels and hemodynamic parameters.
时间窗: at baseline
次要结局
- Not applicable(Not applicable)
研究者
Dr Polavarapu Venkata Abhinaya
Manipal College of Dental Sciences, Manipal