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The Effect of Emotion-Focused Intervention on Emotion Regulation and Well-Being of Individuals With Transplantation

NCT ID: NCT07294183

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-02-28

Brief Summary

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The study was designed to evaluate the effects of an emotion-focused intervention based on the Human-to-Human Relationship Model on emotion regulation skills and well-being in individuals who have undergone renal transplantation. This study was designed as a single-blind randomized controlled trial with a pretest, posttest, and follow-up control group design. Based on the data obtained from the study, the impact of an emotion-focused intervention based on the Human-to-Human Relationship Model on emotion regulation skills and well-being in individuals who have undergone renal transplantation will be evaluated.

Detailed Description

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Chronic diseases are long-term, often lifelong, health problems that seriously impact an individual's quality of life. These diseases require not only medical treatment but also psychosocial support. Chronic diseases such as kidney failure cause physical and psychological challenges.

Renal transplantation is an effective treatment option for individuals with chronic kidney disease. However, the transplant process and its aftermath pose intense emotional challenges for the patient and their family. Patients undergoing transplantation require increased social support mechanisms, which can directly impact the success of treatment. Renal transplantation is considered an emotional experience that can evoke a range of emotions, from relief and gratitude to anxiety and fear. It is believed that using emotion-focused therapy approaches is important for individuals with renal transplantation to recognize their emotions, regulate them, and replace dysfunctional emotions with functional ones. In this context, this study was designed to evaluate the effects of an emotion-focused intervention based on the Human-to-Human Relationship Model on emotion regulation skills and well-being in individuals after renal transplantation. Data from the study, which uses a pretest and posttest control group design, will be collected using the Personal Information Form, the Emotion Regulation Skills Scale, and the Well-Being Scale. Emotion-focused intervention methods will be administered to the intervention group in eight sessions, each lasting approximately 60 minutes per week, while the control group will receive no intervention. The study population will consist of individuals who have undergone organ transplantation at the Akdeniz University Hospital Prof. Dr. Tuncer Karpuzoğlu Organ Transplantation Research and Application Center, and the sample will consist of 56 individuals who have undergone renal transplantation who met the inclusion and exclusion criteria. Data analysis will be done using Social Sciences Statistics Package 29.0. Descriptive statistics will be used to define the sample, using the Student t-test, Mann-Whitney U test, and the Wilcoxon pair test. The study will assess the effectiveness of Emotion-Focused Intervention in this group.

It is anticipated that it will reduce psychosocial symptoms seen in individuals who have undergone renal transplantation and have an impact on their emotion regulation skills and well-being.

Conditions

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Renal Transplantation

Keywords

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Renal Transplantation Emotional Regulation Emotion-Focused Therapy Psychosocial Care Psychiatric Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-blind randomized controlled experimental study with a pretest, posttest, and follow-up control group research design.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
In this study, a single-blind (individuals with renal transplantation) method will be applied. Individuals will not be told which group they are in during the study, thus ensuring that individuals are blinded to the groups.

Study Groups

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Intervention group

It was planned to implement eight sessions of emotion-focused intervention sessions to the intervention group determined according to the inclusion and exclusion criteria.

Group Type EXPERIMENTAL

Emotion-Focused Intervention

Intervention Type BEHAVIORAL

Emotion-Focused Intervention methods will be applied to the intervention group once a week in eight sessions, each lasting an average of 60 minutes. These sessions will begin with the first outpatient follow-up after discharge and will be administered weekly in a designated practice room at the Akdeniz University Hospital Organ Transplant Center.

Control group

No intervention will be made to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Emotion-Focused Intervention

Emotion-Focused Intervention methods will be applied to the intervention group once a week in eight sessions, each lasting an average of 60 minutes. These sessions will begin with the first outpatient follow-up after discharge and will be administered weekly in a designated practice room at the Akdeniz University Hospital Organ Transplant Center.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Volunteering to participate in the study
* Having a renal transplant
* Being over 18 years of age
* Being literate

Exclusion Criteria

* Having any communication disability (reading, hearing, speaking, etc.)
* Participation in another study simultaneously with this study outside of routine clinical practice
* Having another neurological or psychiatric diagnosis affecting cognitive status
* Having previously undergone a renal transplant
* Having undergone multiple organ transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Esra Çelik

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esra ÇELİK

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University Faculty of Nursing

Locations

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Akdeniz University Prof. Dr. Tuncer Karpuzoğlu Organ Transplantation Center

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Esra ÇELİK, RA

Role: CONTACT

Phone: 2422261358

Email: [email protected]

Esra ÇELİK

Role: CONTACT

Phone: 5052420793

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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AkdenizU-HF-EÇ-01

Identifier Type: -

Identifier Source: org_study_id