The Effect of Mindfulness Meditation During Dental Implant Surgery

Cukurova University42 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Mindfulness Dental Implant

Interventions

Mindfulness MeditationOTHER

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

. 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

Locations (1)

Cukurova University Faculty of Dentistry

Adana, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline to 5th, 10th, 15th, 20th, 25th and 30th minutes

Secondary Outcomes

Cortisol

The cortisol levels were biochemically evaluated

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Every 5-minutes starting from baseline until the end of surgery for both groups

Data from ClinicalTrials.gov

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