- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05995938
Mindfullnes-Based Cognitive Therapy Effect ([Mindfullnes])
August 10, 2023 updated by: SEMRA BÜLBÜLOĞLU
Mindfullnes-Based in Surgery Patients for Cognitive Therapy Effect
Objective: In this study, the effect of mindfulness-based cognitive therapy on compliance with immunosuppressive therapy in liver transplant patients was evaluated.
Method: It was conducted the study in a randomized controlled type with n=120 participation of liver transplant recipients of a transplant hospital.
It was applied mindfulness-based cognitive therapy to liver recipients in the experimental group.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
It was used simple random sampling method in assigning liver recipients to the experimental and control groups.
Discharged liver transplant patients are informed about the use of immunosuppressive drugs and the drug is prescribed.
Liver transplant patients drugs.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Malatya, Turkey
- the Liver Transplant Hospital affiliated with Turgut Özal Medical Center of İnönü University of Malatya/Turkey.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Inclusion Criteria involved (i) being a liver transplant recipient, (ii) currently having immunosuppressive treatment, (iii) being 18 years or older (iv) having no language or communication barrier and (v) agreeing to participate in the study.
Liver transplant recipients
Exclusion Criteria:
- The exact opposite of the inclusion criteria the exclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
1
|
Mindfullnes-Based Cognitive Therapy Effect on Adherence to Immunosuppressive Therapy in Liver Transplant Recipients
Other Names:
|
|
No Intervention: Control
1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Effect of Mindfulness-Based Cognitive after Liver Transplantation
Time Frame: Both groups experiment and control. It was used Mindfullnes scale and immunosuppressive terapy adherence scale. It was done measure before and after Mindfullnes-Based Cognitive Therapy.
|
It will be measure Therapy on Liver Transplant Recipients' Adherence to Immunosuppressive Therapy
|
Both groups experiment and control. It was used Mindfullnes scale and immunosuppressive terapy adherence scale. It was done measure before and after Mindfullnes-Based Cognitive Therapy.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindfullnes-Based Cognitive Therapy
Time Frame: total of six month.from 1 october 2022 to 30 Jan 2023
|
le level of Mindfulness-Based Cognitive
|
total of six month.from 1 october 2022 to 30 Jan 2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
January 30, 2023
Study Registration Dates
First Submitted
February 28, 2023
First Submitted That Met QC Criteria
August 10, 2023
First Posted (Actual)
August 16, 2023
Study Record Updates
Last Update Posted (Actual)
August 16, 2023
Last Update Submitted That Met QC Criteria
August 10, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022/3884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.