Protocol summary
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Study aim
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This Study Purpose is determine the effectiveness of mindfulness based stress reduction Treatment on psychological disturbance, intensity of pain and burning, Pain Catastrophizing and Quality of Life of Patients with Oral Lichen Planus.
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Design
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Clinical Trial with Control Group, with Parallel Group, Single Blind, Randomized, on 50 Patients
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Settings and conduct
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Dental clinics affiliated with Kashan University of Medical Sciences and Department of Oral and Dental Diseases of Tehran University of Medical Sciences, Patient who have the Inclusion Criteria are Selected And after Obtaining Informed Consent, they will be Randomly Placed in Experimental and Control Groups Also, before the Implementation of the Intervention, Questionnaires will be Provided to them. The Participants are not Given Information about which of the Groups is the Experimental and which of them is Control Group.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Oral Lichen Planus Patients whose Disease has been Diagnosed through Biopsy and Histopathology Results and who are in the symptomatic phase of the disease.
Non Inclusion Criteria: Absence of Pain and Burning or Mild Pain and Burning (Score Lower than 4 on the VAS), Age younger than 18 and older than 60, Degree less than middle School degree
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Intervention groups
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Experimental Group: Mindfulness Based Stress Reduction is implemented for them.
Control Group: Training Sessions about Some Topics of Developmental Psychology or Personality will be Provided that are not Related to the Main Intervention.
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Main outcome variables
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Psychological Disturbance Score in DASS-21, Pain Catastrophizing Score in Pain Catastrophizing Scale
General information
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Reason for update
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Change in sampling time range due to lack of collaboration of patients
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Acronym
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MBSR
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IRCT registration information
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IRCT registration number:
IRCT20221204056709N1
Registration date:
2022-12-31, 1401/10/10
Registration timing:
prospective
Last update:
2024-07-12, 1403/04/22
Update count:
1
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Registration date
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2022-12-31, 1401/10/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-01-05, 1401/10/15
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Expected recruitment end date
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2023-09-06, 1402/06/15
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Actual recruitment start date
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2023-01-30, 1401/11/10
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Actual recruitment end date
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2024-02-09, 1402/11/20
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Trial completion date
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2024-06-13, 1403/03/24
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Scientific title
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The Effectiveness of Mindfulness Based Stress Reduction (MBSR) Therapy on Psychological Distress among Patients with Oral Lichen Planus
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Public title
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The Effect of Mindfulness Based Stress Reduction Therapy in Improving Oral Lichen Planus Disease
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Oral Lichen Planus Patients whose Disease has been Diagnosed through Biopsy and Histopathology Results.
Patients who are in the Symptomatic Phase of the Disease.
Exclusion criteria:
Absence of Pain and Burning or Mild Pain and Burning (Score Lower than 4 on the VAS).
Age younger than 18 and older than 60
Degree less than middle School degree
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
50
Actual sample size reached:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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According to the Inclusion Criteria, 50 patients with oral lichen planus were purposefully selected and placed in the intervention group and the control group through random assignment using a table of random numbers. In this method, the first selected number (randomly) is placed in the intervention group and the next number is placed in the control group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The blindness of the participants in the treatment is that they do not know that there is another group, but after the end, they will be informed about the existence of another group, and if they wish, the treatment will be done for them. The researcher is aware of the existence of the intervention and control groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-10-23, 1401/08/01
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1401.137
Health conditions studied
1
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Description of health condition studied
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Oral Lichen Planus
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ICD-10 code
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L43
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ICD-10 code description
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Lichen planus
Primary outcomes
1
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Description
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Psychological Disturbance Score in DASS-21
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Timepoint
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Before the Intervention, After the Intervention
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Method of measurement
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DASS-21
2
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Description
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Pain Catastrophizing
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Timepoint
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Before the Intervention, After the Intervention
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Method of measurement
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Pain Catastrophizing Scale
Secondary outcomes
1
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Description
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Severity of Pain and Burning
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Timepoint
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Before the Intervention, After the Intervention
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Method of measurement
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Visual Analouge Scale
2
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Description
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Shape and Size of the Lesions
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Timepoint
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Before the Intervention, After the Intervention
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Method of measurement
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Thongprasom Scale
3
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Description
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Quality of Life Related to Oral Health
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Timepoint
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Before the Intervention, After the Intervention
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Method of measurement
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Oral Health Impact Profile-14 (OHIP-14)
Intervention groups
1
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Description
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Intervention group: Mindfulness Based Stress Reduction was created by Kabat-Zinn (1990), This Treatment is an Eight Week Evidence based Program. The Main Contents of the Treatment are: a) Relaxation Training, Meditation and Mind-Body Connection. b) Teaching Meditation and Yoga Exercises inside and outside the Treatment Session and during the Day c) Removing Barriers to Successful Education, Providing Brochures Related to the Instructions of each Session that were given to the Clients and Daily Homework Exercises
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Category
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Lifestyle
2
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Description
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Control group: The control group does not receive any other treatment except its drug treatment.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available