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

December 7, 2025 updated by: Esra Çelik, Akdeniz University

The Effect of an Emotion-Focused Intervention Based on Travelbee's Human-to-Human Relationship Model on Emotion Regulation Skills and Well-Being of Individuals With Renal Transplantation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

56

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 Contact

Study Contact Backup

Study Locations

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:

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: Control group
No intervention will be made to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion Regulation Skills Scale
Time Frame: six months
This self-report scale, which aims to measure emotion regulation skills in individuals, consists of a total of 27 items. It has nine subscales: awareness/attention (e.g., "I paid attention to my feelings"), body sensations (e.g., "My physical sensations were a good indicator of how I was feeling"), clarity (e.g., "I was sure of what emotions I was experiencing"), understanding (e.g., "I was aware of why I felt this way"), acceptance (e.g., "I accepted my feelings"), tolerance (e.g., "I felt able to tolerate my negative emotions"), preparedness for confrontation (e.g., "Even though it felt uncomfortable or anxious, I did what I planned"), self-support (e.g., "I supported myself in emotionally stressful situations"), and change (e.g., "I was able to influence my negative emotions"). The score of the scale is calculated based on the total score of the items, and a high score indicates high emotion regulation skills.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Well-Being Scale
Time Frame: six months
The scale is a self-report measurement tool that assesses participants' perceptions of their well-being and relies on individuals to provide information about themselves. Scale items range from 1 (strongly disagree) to 7 (strongly agree). A total well-being score is obtained by summing the scores of all items. The highest possible score is 56, and the lowest is 8. Higher scores indicate a higher level of well-being.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Esra ÇELİK, Akdeniz University Faculty of Nursing

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)

July 1, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AkdenizU-HF-EÇ-01

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.

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