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The Effect of Mindfulness Meditation During Dental Implant Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05748223
Enrollment
42
Registered
2023-02-28
Start date
2022-05-20
Completion date
2023-01-13
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant, Mindfulness

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.

Interventions

OTHERMindfulness 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

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

. 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

Design outcomes

Primary

MeasureTime frameDescription
Change of Bispectral Index (BIS) monitoringChange from baseline to 5th, 10th, 15th, 20th, 25th and 30th minutesThe 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

MeasureTime frameDescription
CortisolAt the baseline, immediately before and 5-minutes after surgery for both groups.The cortisol levels were biochemically evaluated
Blood pressureEvery 5-minutes starting from baseline until the end of surgery for both groupssystolic and diastolic blood pressure (in mmHg) via vital signs monitor for both groups
arterial blood oxygen saturationEvery 5-minutes starting from baseline until the end of surgery for both groupsin 'percentage %' via vital signs monitor for both groups
heart rate valueEvery 5-minutes starting from baseline until the end of surgery for both groupsin 'beats per minute' via vital signs monitor for both groups

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026