The Experience, Perceptions and Unexpressed Needs of Heart and Lung Transplant Patients Admitted to Intensive Care (ReF2201)

January 8, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

The Experience, Perceptions and Unexpressed Needs of Heart and Lung Transplant Patients Admitted to Intensive Care: a Qualitative, Descriptive Phenomenological Observational Study

Qualitative descriptive phenomenological study aimed to investigate the experience, perceptions and unexpressed needs of patients undergoing heart and lung transplantation admitted to intensive care unit through semi-structured interviews

Study Overview

Status

Completed

Conditions

Detailed Description

It was conduct a qualitative phenomenological study which, through semi-structured interviews to investigate the experience , the perceptions and the unexpressed needs of patients undergoing heart and lung transplants within the specific context of " High Intensity Cardio-Thoraco-Vascular Hospitalization" of the IRCCS University Hospital of Bologna. The study aims at helping nurses to provide more adequate care, in order to meet the individual needs of patients and describe the meaning and essence of the hospitalization experience, through the in-depth analysis of the specific words pronounced by the patients themselves.

Below are the questions that guided the research:

What is the general experience of the intensive care patients? What are the experiences, the perceptions and the unexpressed needs of these patients in relation to their hospitalization in intensive care?

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

N/A

Sampling Method

Non-Probability Sample

Study Population

The total sample consisted of 21 patients who underwent heart or lung transplants. Of these, 18 patients (86%) had undergone heart transplants, while 3 patients (14%) had undergone lung transplants.

Description

Inclusion Criteria:

  • able to understand and communicate in Italian
  • transferred from intensive to sub-intensive care unit
  • not affected by cognitive disorders
  • who provides informed consent to the study

Exclusion Criteria:

  • none

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience, perceptions and unexpressed needs of heart and lung transplant patients
Time Frame: through study completion, an average of 1 year

This is a prospective qualitative descriptive observational study. Each enrolled patient will undergo a single semi-structured interview.

Following the semi-structured interview technique, the Investigator will have a list of questions to guide the interview and to remains topic-centered. The questions are open-ended.

The questionnaire will be structured into two macro areas:

Questions related to the general experience of the ICU patient; Questions related to the experiences, perceptions and unexpressed needs of ICU patients (including personal impressions of hospital staff).

To avoid potential conditioning and to promote the free expression of the subjects, the interviews will be conducted by a Investigator who is part of ICU research team but not directly involved in patient care.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Nikita Valentina Ugenti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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)

December 1, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ReF2201

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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