The Effect of Mindfulness Meditation on Bispectral Index Monitoring, Physiological Findings and Cortisol Levels During Dental Implant Surgery: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change of Bispectral Index (BIS) monitoring
研究概览
简要总结
The aim of this pioneer study was to evaluate the efficacy (heart rate value, blood pressure, oxygen saturation, cortisol levels, BIS monitoring, patients' anxiety) of Mindfulness Meditation as a sedative technique during dental implant surgery.
详细描述
Since anxiety is a form of psychological stress, an increase in anxiety results in a surge in stress levels. The role of sedation in dental surgery cannot be overemphasised. The reduction in pain and anxiety eventually causes better cooperation and patients' satisfaction. Therefore, balancing anxiety and/or stress levels in patients would be useful to ensure patient safety during treatment.Therefore, the aim of this pioneer study was to evaluate the efficacy (heart rate value, blood pressure, oxygen saturation, cortisol levels, BIS monitoring, patients' anxiety) of Mindfulness Meditation as a sedative technique during dental implant surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •. The inclusion criteria were:
- •age between 25-65 years-old
- •single tooth loss in the maxillary premolar-molar region with partial bone healing (type 3) or fully healed ridge type 4
- •sufficient bony ridge for implant placement without the need for simultaneous bone grafting or sinus lift procedure
- •no signs of acute oral infection,
- •more than 2 mm of keratinized gingiva at the site of surgery
- •periodontally healthy (or successfully treated) and otherwise healthy or had well-controlled systemic disease (ASA classification I, II).
排除标准
- •diabetes mellitus
- •pregnancy;
- •diagnosis of anxiety disorders/psychiatric disorder/ depression and whether or not they were seeking any form of treatment for these conditions;
- •poor oral hygiene (plaque control record > 30%);
- •history of radiation therapy at head and neck area and chemotherapy; bony pathologies; history of soft tissue grafting at the prospective implant site
研究组 & 干预措施
Mindfulness Group
The patients in this group received mindfulness meditation before dental implant surgery.
干预措施: Mindfulness Meditation (Other)
Conventional Group
The patients in this group did not receive mindfulness meditation before dental implant surgery.
结局指标
主要结局
Change of Bispectral Index (BIS) monitoring
时间窗: Change from baseline to 5th, 10th, 15th, 20th, 25th and 30th minutes
The level of sedation achieved by meditation was assessed with BIS device. BIS values range between 100 and 0 and give the clinicians objective information about the depth of sedation.
次要结局
- arterial blood oxygen saturation(Every 5-minutes starting from baseline until the end of surgery for both groups)
- Cortisol(At the baseline, immediately before and 5-minutes after surgery for both groups.)
- Blood pressure(Every 5-minutes starting from baseline until the end of surgery for both groups)
- heart rate value(Every 5-minutes starting from baseline until the end of surgery for both groups)
研究者
Cenk Haytac
Profesor
Cukurova University