MindfulnessNCT05748223
The Effect of Mindfulness Meditation During Dental Implant Surgery
A study testing Mindfulness Meditation in people with Mindfulness and Dental Implant, run by Cukurova University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Dental Implant
- What is being tested?
- Mindfulness Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2022to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Dentistry
Adana
About this study
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
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.
Read the 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.
- Conditions
- Mindfulness, Dental Implant
- Being tested
- Mindfulness Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Group | Experimental | The patients in this group received mindfulness meditation before dental implant surgery. Receives: Other: Mindfulness Meditation |
| Conventional Group | No intervention | The patients in this group did not receive mindfulness meditation before dental implant surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 5th, 10th, 15th, 20th, 25th and 30th minutes
Secondary outcomes (4)
Cortisol
The cortisol levels were biochemically evaluated
Measured: At the baseline, immediately before and 5-minutes after surgery for both groups.
Blood pressure
systolic and diastolic blood pressure (in mmHg) via vital signs monitor for both groups
Measured: Every 5-minutes starting from baseline until the end of surgery for both groups
arterial blood oxygen saturation
in 'percentage %' via vital signs monitor for both groups
Measured: Every 5-minutes starting from baseline until the end of surgery for both groups
heart rate value
in 'beats per minute' via vital signs monitor for both groups
Measured: Every 5-minutes starting from baseline until the end of surgery for both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start20 May 2022
- Primary completion11 Nov 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Haytac, Cukurova University
- Investigators
- Onur Ucak Turer, Professor, Principal investigator, Professor in Periodontology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748223
- Sponsor's protocol ID
- Cukurova U
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05748223
- Acronym / sponsor ID
- Cukurova U
- Conditions
- Mindfulness, Dental Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Group | Experimental | Other: Mindfulness MeditationThe patients in this group received mindfulness meditation before dental implant surgery. |
| Conventional Group | No intervention | –The patients in this group did not receive mindfulness meditation before dental implant surgery. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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%);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness MeditationMindfulness 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 | Other | Mindfulness Group |
Primary outcome
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.
4 secondary outcomes
Cortisol
Time frame: At the baseline, immediately before and 5-minutes after surgery for both groups.
Blood pressure
Time frame: Every 5-minutes starting from baseline until the end of surgery for both groups
arterial blood oxygen saturation
Time frame: Every 5-minutes starting from baseline until the end of surgery for both groups
heart rate value
Time frame: Every 5-minutes starting from baseline until the end of surgery for both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onur Ucak Turer, Professor principal investigator
Professor in Periodontology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation in people with Mindfulness and Dental Implant, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Bispectral Index (BIS) monitoring (time frame: Change from baseline to 5th, 10th, 15th, 20th, 25th and 30th minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.