NCT06804720

Brief Summary

Although studies have highlighted the relationship between stress-related psychopathological symptoms and changes in biochemical parameters, no study in dentistry has concurrently evaluated the association of stress and relaxation with biochemical markers and psychological parameters. Moreover, the impact of mindfulness-based self-compassion training programs on these variables has yet to be explored within this context. To enhance the well-being of dentists, an evaluation of a test group participating in an 8-week Mindfulness-Based Compassionate Living (MBCL) program was conducted. This assessment included daily cortisol curves, as well as salivary IL-6, IL-1β, and oxytocin levels. Additionally, empathy, burnout, self-compassion, depression, and mindfulness levels were measured before and after the training. In this study, the main hypothesis was that, compared to the control group, the test group would exhibit lower IL-1β, IL-6, and cortisol levels, along with higher oxytocin levels. Furthermore, as the secondary hypotheses was that the test group would demonstrate increased empathy, self-compassion, and mindfulness levels, accompanied by reductions in depression and burnout scores.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

January 20, 2025

Last Update Submit

January 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-Compassion Scale

    The 6 subscales that comprise the 26-item self-compassion scale are self-kindness, self-judgment , common humanity , isolation , mindfulness and over-identification Participants indicate their responses to each item using a 5-point scale ranging from 1 (Almost Never) to 5 (Almost Always). Higher score indicates greater self-compassion.

    Baseline and after 8 weeks

Secondary Outcomes (2)

  • Saliva Cortisol

    Baseline and after 8 weeks

  • Saliva IL 6

    Baseline and after 8 weeks

Study Arms (2)

Test group (Self Compassion Training group)

EXPERIMENTAL
Behavioral: Mindfulness based Self compassion

Control group (No training)

NO INTERVENTION

Interventions

All participants in the test group completed the 8-week MBCL (Mindfulness-Based Compassionate Living) training, consisting of 2-hour sessions per week, in accordance with the MBCL training protocol. Training was conducted by one expert periodontist who is also an internationally certified MBCL instructor

Test group (Self Compassion Training group)

Eligibility Criteria

Age24 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • dentists in their final year of specialty training at the Faculty of Dentistry,
  • systemicaly healthy

You may not qualify if:

  • individuals who received a diagnosis of mood disorders based on DSM-5 criteria following a standard diagnostic assessment conducted by psychiatrists from the Department of Psychiatry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova UNiversity faculty of dentistry

Adana, Balcali, 01130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2025

First Posted

February 3, 2025

Study Start

March 1, 2024

Primary Completion

December 11, 2024

Study Completion

January 12, 2025

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations