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Completed

NCT Number: NCT05748223

The Effect of Mindfulness Meditation During Dental Implant Surgery

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University Faculty of Dentistry

Adana, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

. 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

Treatment and study plan

Mindfulness meditation

Other

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

Primary outcomes

  1. Change of Bispectral Index (BIS) monitoring

    Time frame: 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 outcomes

  1. Cortisol

    Time frame: At the baseline, immediately before and 5-minutes after surgery for both groups.

    The cortisol levels were biochemically evaluated

  2. Blood pressure

    Time frame: 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

  3. arterial blood oxygen saturation

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

    in 'percentage %' via vital signs monitor for both groups

  4. heart rate value

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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