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Mindfullnes-Based Cognitive Therapy Effect ([Mindfullnes])

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ClinicalTrials.gov Identifier: NCT05995938
Recruitment Status : Completed
First Posted : August 16, 2023
Last Update Posted : August 16, 2023
Sponsor:
Information provided by (Responsible Party):
SEMRA BÜLBÜLOĞLU, Istanbul Aydın University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mindfullnes-Based Cognitive Therapy and Adherence to Immunosuppressive Therapy Behavioral: Mindfullnes-Based Cognitive Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Experimental
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mindfullnes-Based in Surgery Patients for Cognitive Therapy Effect
Actual Study Start Date : August 1, 2022
Actual Primary Completion Date : January 1, 2023
Actual Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
1
 Behavioral: Mindfullnes-Based Cognitive Therapy
Mindfullnes-Based Cognitive Therapy Effect on Adherence to Immunosuppressive Therapy in Liver Transplant Recipients
Other Name: [Mindfulness]
No Intervention: Control
1


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mindfullnes-Based Cognitive Therapy [ Time Frame: total of six month.from 1 october 2022 to 30 Jan 2023 ]
    le level of Mindfulness-Based Cognitive


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05995938


Locations
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Turkey
the Liver Transplant Hospital affiliated with Turgut Özal Medical Center of İnönü University of Malatya/Turkey.
Malatya, Turkey
Sponsors and Collaborators
SEMRA BÜLBÜLOĞLU
More Information
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Responsible Party: SEMRA BÜLBÜLOĞLU, Clinical Associate Professor, Istanbul Aydın University
ClinicalTrials.gov Identifier: NCT05995938    
Other Study ID Numbers: 2022/3884
First Posted: August 16, 2023    Key Record Dates
Last Update Posted: August 16, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SEMRA BÜLBÜLOĞLU, Istanbul Aydın University:
Liver Recipients
Transplantation
Mindfulness