The Effect of Mindfulness Meditation During Dental Implant Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Mindfulness Meditation on Bispectral Index Monitoring, Physiological Findings and Cortisol Levels During Dental Implant Surgery: A Randomized Controlled Clinical Trial

Conditions
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Mindfulness, Dental Implant

Intervention / Treatment
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* Other: Mindfulness Meditation


Participation Criteria
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Eligibility Criteria
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. 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). Exclusion criteria were diabetes mellitus smoking 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Group<br>The patients in this group received mindfulness meditation before dental implant surgery. | Other: Mindfulness Meditation<br>* Mindfulness meditation has been reported to produce beneficial effects on a number of psychiatric, functional somatic, and stress-related symptoms and has therefore increasingly been incorporated into psychotherapeutic programs<br>|
| No Intervention: Conventional Group<br>The patients in this group did not receive mindfulness meditation before dental implant surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Bispectral Index (BIS) monitoring | 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. | Change from baseline to 5th, 10th, 15th, 20th, 25th and 30th minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol | The cortisol levels were biochemically evaluated | At the baseline, immediately before and 5-minutes after surgery for both groups. | 
| Blood pressure | systolic and diastolic blood pressure (in mmHg) via vital signs monitor for both groups | Every 5-minutes starting from baseline until the end of surgery for both groups | 
| arterial blood oxygen saturation | in 'percentage %' via vital signs monitor for both groups | Every 5-minutes starting from baseline until the end of surgery for both groups | 
| heart rate value | in 'beats per minute' via vital signs monitor for both groups | Every 5-minutes starting from baseline until the end of surgery for both groups |