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

June 5, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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