The Effect of Mindfulness Meditation During Dental Implant Surgery

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748223
• Other study ID #: Cukurova U
• Status: Completed
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: January 13, 2023

Study information

• Verified date: February 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 13, 2023
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

. 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

Related Conditions & MeSH terms

• Dental Implant
• Mindfulness

Intervention

Other:
• Mindfulness Meditation
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

Locations

Country	Name	City	State
Turkey	Cukurova University Faculty of Dentistry	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cortisol	The cortisol levels were biochemically evaluated	At the baseline, immediately before and 5-minutes after surgery for both groups.
Secondary	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
Secondary	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
Secondary	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