Heart and Lung TransplantsReF2201NCT06773052
The Experience, Perceptions and Unexpressed Needs of Heart and Lung Transplant Patients Admitted to Intensive Care
An observational study of Heart and Lung Transplants, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart and Lung Transplants
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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?
- Conditions
- Heart and Lung Transplants
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience, perceptions and unexpressed needs of heart and lung transplant patients
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Dec 2022
- Primary completion30 Sep 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart and Lung TransplantsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikita Valentina Ugenti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773052
- Sponsor's protocol ID
- ReF2201
- Acronym
- ReF2201
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ugenti NV, Quirini S, Aleandri M, Di Filippo V, Durante S, Ferretti A, Guerrieri C, Martella C, Peghetti A, Sgarzi S, Valentini S, Vetromile A, Lia E. Experiences, perceptions and unexpressed needs of patients undergoing heart and lung transplantation in intensive care unit: a qualitative phenomenological study. Front Psychol. 2025 Sep 9;16:1646086. doi: 10.3389/fpsyg.2025.1646086. eCollection 2025.
PubMed 40994850
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience, Perceptions and Unexpressed Needs of Heart and Lung Transplant Patients Admitted to Intensive Care: a Qualitative, Descriptive Phenomenological Observational Study
- ClinicalTrials.gov ID
- NCT06773052
- Acronym / sponsor ID
- ReF2201 / ReF2201
- Conditions
- Heart and Lung Transplants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Derived from this study: PubMed 40994850Ugenti NV, Quirini S, Aleandri M, Di Filippo V, Durante S, Ferretti A, Guerrieri C, Martella C, Peghetti A, Sgarzi S, Valentini S, Vetromile A, Lia E. Experiences, perceptions and unexpressed needs of patients undergoing heart and lung transplantation in intensive care unit: a qualitative phenomenological study. Front Psychol. 2025 Sep 9;16:1646086. doi: 10.3389/fpsyg.2025.1646086. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikita Valentina Ugenti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart and Lung Transplants, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience, perceptions and unexpressed needs of heart and lung transplant patients (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06773052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.