The Effect of Mindfulness Meditation During Dental Implant Surgery

Sponsor

Cukurova University (Other)

Overall Status

Completed

CT.gov ID

NCT05748223

Collaborator

(none)

Enrollment

Location

Arms

7.8

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mindfulness Dental Implant	Other: Mindfulness Meditation	N/A

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

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

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

Actual Study Start Date :

May 20, 2022

Actual Primary Completion Date :

Nov 11, 2022

Actual Study Completion Date :

Jan 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness Group The patients in this group received mindfulness meditation before dental implant surgery.	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
No Intervention: Conventional Group The patients in this group did not receive mindfulness meditation before dental implant surgery.

Arm

Intervention/Treatment

Experimental: Mindfulness Group

The patients in this group received mindfulness meditation before dental implant surgery.

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

No Intervention: Conventional Group

The patients in this group did not receive mindfulness meditation before dental implant surgery.

Outcome Measures

Primary Outcome Measures

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

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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova University Faculty of Dentistry	Adana		Turkey

Sponsors and Collaborators

Cukurova University

Investigators

Principal Investigator: Onur Ucak Turer, Professor, Professor in Periodontology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cenk Haytac, Profesor, Cukurova University

ClinicalTrials.gov Identifier:

NCT05748223

Other Study ID Numbers:

Cukurova U

First Posted:

Feb 28, 2023

Last Update Posted:

Feb 28, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 28, 2023