The Effect of Mindfulness Meditation During Dental Implant Surgery

Not Applicable

Completed

• Conditions: Mindfulness; Dental Implant
• Interventions: Other: Mindfulness Meditation

• Registration Number: NCT05748223
• Lead Sponsor: Cukurova University

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 Timeline

• Study Start: 2022-05-20
• Primary Completion: 2022-11-11
• Study Completion: 2023-01-13
• Status Verified: 2023-02
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-24
• Last Update Submitted: 2023-02-24
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Group	Mindfulness Meditation	The patients in this group received mindfulness meditation before dental implant surgery.

Primary Outcome Measures

Name	Time	Method
Change of Bispectral Index (BIS) monitoring	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 Outcome Measures

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

Trial Locations

Locations (1)

Cukurova University Faculty of Dentistry; 🇹🇷 Adana, Turkey