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

NCT07294183 | Recruiting

• 1 other identifier: AkdenizU-HF-EÇ-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Emotion Regulation Skills Scale

  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 Outcomes (1)

• Well-Being Scale

  six months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No intervention will be made to the control group.

Interventions

Emotion-Focused Intervention 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Prof. Dr. Tuncer Karpuzoğlu Organ Transplantation Center

Antalya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Esra ÇELİK

  Akdeniz University Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra ÇELİK, RA

CONTACT

2422261358; esrac@akdeniz.edu.tr

Esra ÇELİK

CONTACT

5052420793; esrac@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: A single-blind randomized controlled experimental study with a pretest, posttest, and follow-up control group research design.

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: July 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 28, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

TU (1)