The Effect of Mindfulness Meditation on Bispectral Index Monitoring, Physiological Findings and Cortisol Levels During Dental Implant Surgery: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cukurova University
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change of Bispectral Index (BIS) monitoring
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change of Bispectral Index (BIS) monitoring
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Cenk Haytac
Profesor
Cukurova University