DyspneaNCT06922292
"Turkish Validation of the Respiratory Distress Observation Scale in Palliative Care"
An observational study of Dyspnea and Palliative Care, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Dyspnea is a subjective experience influenced by physiological, cognitive, behavioral, and sociocultural factors. While self-reported scales are commonly used to assess dyspnea severity, they are unsuitable for patients unable to communicate, such as those with cognitive impairment or sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Palliative Care, Reliability and Validity
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 30 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving inpatient treatment in the Intensive Care Unit who meet the inclusion criteria will be included in the study. The relatives of eligible patients will be informed about the study, and informed consent will be obtained. The study will be conducted in accordance with the principles of the Helsinki Declaration and Good Clinical Practice guidelines. Participants included in the study will be assigned a unique code (based on date of birth and order of participation).
Who may be able to join
- Aged 18 years or older,
- Diagnosed with lung or pleural cancer, chronic kidney failure, congestive heart failure, COPD, asthma, or pneumonia, and experiencing dyspnea,
- Specifically referred for treatment of dyspnea,
- Residing in a palliative care unit for at least 1 day,
- Willing to participate in the study, either personally or through consent from a family member.
Who cannot join
- Completely dependent on a ventilator,
- Diagnosed with a central nervous system disorder (Quadriplegia, Bulbar ALS).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation, Validity, and Reliability of the Respiratory Distress Observation Scale in Adult Palliative Care Patients: A Turkish Version
Dyspnea is a subjective experience influenced by physiological, cognitive, behavioral, and sociocultural factors. While self-reported scales are commonly used to assess dyspnea severity, they are unsuitable for patients unable to communicate, such as those with cognitive impairment or sedation. The Respiratory Distress Observation Scale (RDOS), developed by Campbell in 2008, is a reliable and valid tool for evaluating dyspnea in non-communicative palliative care patients. The RDOS has been adapted into Chinese and Italian, but a Turkish version is lacking. This study aims to assess the reliability and validity of the Turkish version of the RDOS.
Read the detailed description
Any disorder affecting the components of the respiratory system directly impacts respiratory function, while impairments in other systems related to this system indirectly hinder respiratory function. This condition manifests in patients in various ways, including shortness of breath, air hunger, difficulty breathing, a sensation of suffocation, and chest tightness, influenced by physiological, cognitive, behavioral, and sociocultural factors. Under normal conditions, breathing is an unconscious physiological act that goes unnoticed. However, in the presence of the aforementioned disturbances, conscious awareness of the act of breathing emerges. According to the American Thoracic Society (ATS) report, dyspnea is defined as "a subjective experience of breathing discomfort that consists of qualitatively distinct sensations of varying intensity" and is acknowledged as a subjective sensation.
Dyspnea does not result from a single pathophysiological mechanism but may develop due to dysfunctions in multiple systems. Therefore, both identifying the underlying pathophysiology of dyspnea and measuring its presence and severity, given its subjective nature, are of great importance. Dyspnea assessment has been conducted using psychophysical methods and clinical scales. Psychophysical tests measure the perception of respiratory changes in response to externally applied loads, whereas clinical scales aim to determine the magnitude of the work contributing to breathlessness in patients. In addition to identifying the cause of dyspnea and initiating appropriate treatment, accurately measuring dyspnea severity plays a crucial role in planning both medical treatment and pulmonary rehabilitation interventions.
The assessment of dyspnea presence and severity is based on self-reported scales, which are considered partially objective. However, some patients-such as those with cognitive impairment, loss of consciousness, intubation, sedative medication use, or brain injury-are unable to provide self-reports. Monitoring dyspnea in patients unable to self-report has been reported as challenging. In clinical settings, healthcare professionals rely on respiratory rate and oxygen saturation levels to assess dyspnea severity and determine appropriate treatment strategies for such patients.
In Turkey, scales used to assess the presence and severity of dyspnea are based on self-reporting and are therefore not suitable for patients unable to communicate their symptoms. In 2008, Dr. Campbell developed the Respiratory Distress Observation Scale (RDOS) and demonstrated its reliability and validity in patients receiving palliative care-such as those with cancer, chronic obstructive pulmonary disease (COPD), heart failure, and pneumonia-who are unable to self-report their dyspnea. The RDOS consists of eight indicators related to dyspnea and takes less than five minutes to administer. Originally developed in English, the RDOS has been translated into Chinese and Italian. However, a Turkish version of the scale is needed. This study aims to examine the reliability and validity of the Turkish version of the RDOS.
- Conditions
- Dyspnea, Palliative Care, Reliability and Validity
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Palliative Care Patients With Respiratory Distress | Adult inpatients (≥18 years) receiving palliative care in hospital units, diagnosed with conditions such as lung or pleural cancer, chronic kidney disease, congestive heart failure, COPD, asthma, or pneumonia, and experiencing respiratory distress. Patients must have been staying in the palliative care unit for at least one day and either personally or via a family member provided informed consent to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Distress Observation Scale (RDOS)
The RDOS was developed by Campbell to measure the presence and intensity of respiratory distress for patients who are unable to self-report dyspnea. The eight parameters assessed by the observer are assess heart rate, respiratory, restlessness, paradoxical breathing pattern, accessory muscle use, grunting at end-expiration, nasal flaring, and look of fear. Four parameters scored between 0 and 2 points; the other four parameters scored 0, or 2 points and progressed from most to least severity of distress. The intensity of respiratory distress is reflected by a total score ranging from 0 to 18. A high total score increases the risk of developing respiratory distress. RDOS score of 0 to 2 suggests no respiratory distress; a score of 3, mild distress; scores of 4 to 6, moderate distress; and 7 or greater, severe distress, with an adequate cutoff point for assigning clinical significance at a score of 3.
Measured: Within the first assessment (Day 1) and repeated measures within 2 hours after baseline assessment
Secondary outcomes (19)
Heart Rate Assessment
Heart rate (beats per minute) will be extracted from patient records within 30 minutes before the RDOS (Respiratory Distress Observation Scale) assessment.
Measured: Within 30 minutes prior to RDOS administration
Systolic Blood Pressure Assessment
Systolic blood pressure (mmHg) will be recorded from clinical documentation within 30 minutes before RDOS administration.
Measured: Within 30 minutes prior to RDOS administration
Diastolic Blood Pressure Assessment
Diastolic blood pressure (mmHg) will be obtained from the patient's chart and used as a physiological indicator at the time of RDOS evaluatio
Measured: Within 30 minutes prior to RDOS administration
Respiratory Rate Assessment
Respiratory rate (breaths per minute) will be noted from medical records as a clinical vital sign prior to RDOS assessment.
Measured: Within 30 minutes prior to RDOS administration
Oxygen Saturation Assessment
Peripheral oxygen saturation (SpO₂, %) will be documented from the monitoring system or medical record shortly before RDOS scoring.
Measured: Within 30 minutes prior to RDOS administration
Body Temperature Assessment
Body temperature (°C) will be recorded from the most recent measurement available before the RDOS is administered.
Measured: Within 30 minutes prior to RDOS administration
Partial Pressure of Oxygen (PaO₂) Assessment
The most recent arterial partial pressure of oxygen (PaO₂, mmHg) will be obtained from medical records. The sample must be collected within 30 minutes prior to RDOS assessment.
Measured: Within 30 minutes prior to RDOS administration
Partial Pressure of Carbon Dioxide (PaCO₂) Assessment
Arterial partial pressure of carbon dioxide (PaCO₂, mmHg) will be recorded from laboratory results. The value must be based on a sample taken no more than 30 minutes before RDOS administration.
Measured: Within 30 minutes prior to RDOS administration
Arterial Oxygen Saturation (SaO₂) Assessment
SaO₂ (%) will be documented from arterial blood gas analysis and used as an objective indicator of blood oxygenation status.
Measured: Within 30 minutes prior to RDOS administration
Blood pH Assessment
Arterial blood pH values will be extracted from the most recent arterial blood gas test, conducted within 30 minutes prior to RDOS application.
Measured: Within 30 minutes prior to RDOS administration
Bicarbonate (HCO₃-) Assessment
The bicarbonate (HCO₃-, mmol/L) level will be obtained from arterial blood gas test results and analyzed as part of metabolic status assessment.
Measured: Within 30 minutes prior to RDOS administration
Dyspnea Assessment
Verbal Dyspnea Scale (VDS):Conscious patients will self-rate their level of breathlessness on a 0-10 numeric rating scale, where 0 indicates no dyspnea and 10 indicates the most severe dyspnea.
Measured: At baseline
ICU Stay Duration
Duration of stay in the intensive care unit (ICU) will be recorded in days from hospital records.
Measured: At enrollment
Glasgow Coma Scale (GCS) Assessment
The Glasgow Coma Scale score will be recorded to assess the participant's level of consciousness. The Glasgow Coma Scale (GCS) will be used to determine the patient's level of consciousness. The Glasgow Coma Scale (GCS) assesses consciousness by evaluating three components: eye opening (4-1), verbal response (5-1), and motor response (6-1). Scores range from 3 (deep coma) to 15 (fully alert), with lower scores indicating more severe impairment. A score of 8 or below typically suggests the need for immediate intervention.
Measured: At enrollment
Clock Drawing Test Assessment
Cognitive function will be assessed using the Clock Drawing Test, scored based on spatial and time-setting accuracy.
Measured: At enrollment
Palliative Performance Scale (PPS) Score Assessment
The Palliative Performance Scale (PPS) is a validated clinical tool used to assess the functional status of patients receiving palliative care. It ranges from 0% (death) to 100% (fully active) in 10% increments, based on five parameters: ambulation, activity level and extent of disease, self-care ability, oral intake, and level of consciousness. A high PPS score (e.g., 80-100%) indicates that the patient is active, independent, and has minimal care needs, while a low PPS score (e.g., 10-30%) reflects a patient who is bedbound, has limited intake and consciousness, and requires full care. PPS is widely used to estimate survival time, guide care planning, and classify patients in clinical research. Lower scores are associated with reduced life expectancy and higher dependency.
Measured: At enrollment
Type of Respiratory Support Assessment
The type of respiratory support (e.g., High-Flow Oxygen [HFO], Non-Invasive Mechanical Ventilation [NIMV], Invasive Mechanical Ventilation [IMV]) used at the time of RDOS assessment will be documented.
Measured: At enrollment
Fraction of Inspired Oxygen (FiO₂) Assessment
FiO₂ (%) values will be documented from respiratory support devices to assess oxygen delivery.
Measured: At baseline
PaO₂/FiO₂ Ratio Assessment
The ratio of arterial oxygen pressure (PaO₂) to inspired oxygen fraction (FiO₂) will be calculated to assess oxygenation efficiency.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Feb 2025
- Primary completion20 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kabasakal, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922292
- Sponsor's protocol ID
- ISU-2025-001
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tinti S, Destrebecq A, Terzoni S, De Maria B, Falcone G, Da Col D, Pairona G, Longhi C, Giudici E, Pidone IM, Alberti A, Sofia M, Ramponi I, Campbell ML. Respiratory Distress Observation Scale Italian Version: Cultural-Linguistic Validation and Psychometric Properties. J Hosp Palliat Nurs. 2021 Apr 1;23(2):187-194. doi: 10.1097/NJH.0000000000000736.
PubMed 33633100Pianosi PT, Zhang Z, Hernandez P, Huebner M. Measuring Dyspnea and Perceived Exertion in Healthy Adults and with Respiratory Disease: New Pictorial Scales. Sports Med Open. 2016;2:17. doi: 10.1186/s40798-015-0038-4. Epub 2016 Jan 7.
PubMed 26770885Eakin EG, Resnikoff PM, Prewitt LM, Ries AL, Kaplan RM. Validation of a new dyspnea measure: the UCSD Shortness of Breath Questionnaire. University of California, San Diego. Chest. 1998 Mar;113(3):619-24. doi: 10.1378/chest.113.3.619.
PubMed 9515834Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
PubMed 22336677Ambrosino N, Porta R. Measurement of dyspnoea. Monaldi Arch Chest Dis. 2001 Feb;56(1):39-42.
PubMed 11407208Dyspnea. Mechanisms, assessment, and management: a consensus statement. American Thoracic Society. Am J Respir Crit Care Med. 1999 Jan;159(1):321-40. doi: 10.1164/ajrccm.159.1.ats898. No abstract available.
PubMed 9872857Coccia CB, Palkowski GH, Schweitzer B, Motsohi T, Ntusi NA. Dyspnoea: Pathophysiology and a clinical approach. S Afr Med J. 2016 Jan;106(1):32-6. doi: 10.7196/samj.2016.v106i1.10324.
PubMed 26933707
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation, Validity, and Reliability of the Respiratory Distress Observation Scale in Adult Palliative Care Patients: A Turkish Version
- ClinicalTrials.gov ID
- NCT06922292
- Acronym / sponsor ID
- ISU-2025-001
- Conditions
- Dyspnea, Palliative Care, Reliability and Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 10 Apr 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.
Dyspnea is a subjective experience influenced by physiological, cognitive, behavioral, and sociocultural factors. While self-reported scales are commonly used to assess dyspnea severity, they are unsuitable for patients unable to communicate, such as those with cognitive impairment or sedation. The Respiratory Distress Observation Scale (RDOS), developed by Campbell in 2008, is a reliable and valid tool for evaluating dyspnea in non-communicative palliative care patients. The RDOS has been adapted into Chinese and Italian, but a Turkish version is lacking. This study aims to assess the reliability and validity of the Turkish version of the RDOS.
Detailed description
Any disorder affecting the components of the respiratory system directly impacts respiratory function, while impairments in other systems related to this system indirectly hinder respiratory function. This condition manifests in patients in various ways, including shortness of breath, air hunger, difficulty breathing, a sensation of suffocation, and chest tightness, influenced by physiological, cognitive, behavioral, and sociocultural factors. Under normal conditions, breathing is an unconscious physiological act that goes unnoticed. However, in the presence of the aforementioned disturbances, conscious awareness of the act of breathing emerges. According to the American Thoracic Society (ATS) report, dyspnea is defined as "a subjective experience of breathing discomfort that consists of qualitatively distinct sensations of varying intensity" and is acknowledged as a subjective sensation.
Dyspnea does not result from a single pathophysiological mechanism but may develop due to dysfunctions in multiple systems. Therefore, both identifying the underlying pathophysiology of dyspnea and measuring its presence and severity, given its subjective nature, are of great importance. Dyspnea assessment has been conducted using psychophysical methods and clinical scales. Psychophysical tests measure the perception of respiratory changes in response to externally applied loads, whereas clinical scales aim to determine the magnitude of the work contributing to breathlessness in patients. In addition to identifying the cause of dyspnea and initiating appropriate treatment, accurately measuring dyspnea severity plays a crucial role in planning both medical treatment and pulmonary rehabilitation interventions.
The assessment of dyspnea presence and severity is based on self-reported scales, which are considered partially objective. However, some patients-such as those with cognitive impairment, loss of consciousness, intubation, sedative medication use, or brain injury-are unable to provide self-reports. Monitoring dyspnea in patients unable to self-report has been reported as challenging. In clinical settings, healthcare professionals rely on respiratory rate and oxygen saturation levels to assess dyspnea severity and determine appropriate treatment strategies for such patients.
In Turkey, scales used to assess the presence and severity of dyspnea are based on self-reporting and are therefore not suitable for patients unable to communicate their symptoms. In 2008, Dr. Campbell developed the Respiratory Distress Observation Scale (RDOS) and demonstrated its reliability and validity in patients receiving palliative care-such as those with cancer, chronic obstructive pulmonary disease (COPD), heart failure, and pneumonia-who are unable to self-report their dyspnea. The RDOS consists of eight indicators related to dyspnea and takes less than five minutes to administer. Originally developed in English, the RDOS has been translated into Chinese and Italian. However, a Turkish version of the scale is needed. This study aims to examine the reliability and validity of the Turkish version of the RDOS.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Palliative Care Patients With Respiratory Distress | – | –Adult inpatients (≥18 years) receiving palliative care in hospital units, diagnosed with conditions such as lung or pleural cancer, chronic kidney disease, congestive heart failure, COPD, asthma, or pneumonia, and experiencing respiratory distress. Patients must have been staying in the palliative care unit for at least one day and either personally or via a family member provided informed consent to participate in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving inpatient treatment in the Intensive Care Unit who meet the inclusion criteria will be included in the study. The relatives of eligible patients will be informed about the study, and informed consent will be obtained. The study will be conducted in accordance with the principles of the Helsinki Declaration and Good Clinical Practice guidelines. Participants included in the study will be assigned a unique code (based on date of birth and order of participation).
Key inclusion criteria (5 listed)
- Aged 18 years or older,
- Diagnosed with lung or pleural cancer, chronic kidney failure, congestive heart failure, COPD, asthma, or pneumonia, and experiencing dyspnea,
- Specifically referred for treatment of dyspnea,
- Residing in a palliative care unit for at least 1 day,
- Willing to participate in the study, either personally or through consent from a family member.
Key exclusion criteria (2 listed)
- Completely dependent on a ventilator,
- Diagnosed with a central nervous system disorder (Quadriplegia, Bulbar ALS).
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
Respiratory Distress Observation Scale (RDOS)
Time frame: Within the first assessment (Day 1) and repeated measures within 2 hours after baseline assessment
The RDOS was developed by Campbell to measure the presence and intensity of respiratory distress for patients who are unable to self-report dyspnea. The eight parameters assessed by the observer are assess heart rate, respiratory, restlessness, paradoxical breathing pattern, accessory muscle use, grunting at end-expiration, nasal flaring, and look of fear. Four parameters scored between 0 and 2 points; the other four parameters scored 0, or 2 points and progressed from most to least severity of distress. The intensity of respiratory distress is reflected by a total score ranging from 0 to 18. A high total score increases the risk of developing respiratory distress. RDOS score of 0 to 2 suggests no respiratory distress; a score of 3, mild distress; scores of 4 to 6, moderate distress; and 7 or greater, severe distress, with an adequate cutoff point for assigning clinical significance at a score of 3.
19 secondary outcomes
Heart Rate Assessment
Time frame: Within 30 minutes prior to RDOS administration
Systolic Blood Pressure Assessment
Time frame: Within 30 minutes prior to RDOS administration
Diastolic Blood Pressure Assessment
Time frame: Within 30 minutes prior to RDOS administration
Respiratory Rate Assessment
Time frame: Within 30 minutes prior to RDOS administration
Oxygen Saturation Assessment
Time frame: Within 30 minutes prior to RDOS administration
Body Temperature Assessment
Time frame: Within 30 minutes prior to RDOS administration
Partial Pressure of Oxygen (PaO₂) Assessment
Time frame: Within 30 minutes prior to RDOS administration
Partial Pressure of Carbon Dioxide (PaCO₂) Assessment
Time frame: Within 30 minutes prior to RDOS administration
Arterial Oxygen Saturation (SaO₂) Assessment
Time frame: Within 30 minutes prior to RDOS administration
Blood pH Assessment
Time frame: Within 30 minutes prior to RDOS administration
Bicarbonate (HCO₃-) Assessment
Time frame: Within 30 minutes prior to RDOS administration
Dyspnea Assessment
Time frame: At baseline
ICU Stay Duration
Time frame: At enrollment
Glasgow Coma Scale (GCS) Assessment
Time frame: At enrollment
Clock Drawing Test Assessment
Time frame: At enrollment
Palliative Performance Scale (PPS) Score Assessment
Time frame: At enrollment
Type of Respiratory Support Assessment
Time frame: At enrollment
Fraction of Inspired Oxygen (FiO₂) Assessment
Time frame: At baseline
PaO₂/FiO₂ Ratio Assessment
Time frame: At baseline
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 10 Feb 2026.
- Background: PubMed 33633100Tinti S, Destrebecq A, Terzoni S, De Maria B, Falcone G, Da Col D, Pairona G, Longhi C, Giudici E, Pidone IM, Alberti A, Sofia M, Ramponi I, Campbell ML. Respiratory Distress Observation Scale Italian Version: Cultural-Linguistic Validation and Psychometric Properties. J Hosp Palliat Nurs. 2021 Apr 1;23(2):187-194. doi: 10.1097/NJH.0000000000000736.
- Background: PubMed 26770885Pianosi PT, Zhang Z, Hernandez P, Huebner M. Measuring Dyspnea and Perceived Exertion in Healthy Adults and with Respiratory Disease: New Pictorial Scales. Sports Med Open. 2016;2:17. doi: 10.1186/s40798-015-0038-4. Epub 2016 Jan 7.
- Background: PubMed 9515834Eakin EG, Resnikoff PM, Prewitt LM, Ries AL, Kaplan RM. Validation of a new dyspnea measure: the UCSD Shortness of Breath Questionnaire. University of California, San Diego. Chest. 1998 Mar;113(3):619-24. doi: 10.1378/chest.113.3.619.
- Background: PubMed 22336677Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
- Results publication: PubMed 11407208Ambrosino N, Porta R. Measurement of dyspnoea. Monaldi Arch Chest Dis. 2001 Feb;56(1):39-42.
- Results publication: PubMed 9872857Dyspnea. Mechanisms, assessment, and management: a consensus statement. American Thoracic Society. Am J Respir Crit Care Med. 1999 Jan;159(1):321-40. doi: 10.1164/ajrccm.159.1.ats898. No abstract available.
- Results publication: PubMed 26933707Coccia CB, Palkowski GH, Schweitzer B, Motsohi T, Ntusi NA. Dyspnoea: Pathophysiology and a clinical approach. S Afr Med J. 2016 Jan;106(1):32-6. doi: 10.7196/samj.2016.v106i1.10324.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dyspnea and Palliative Care, run by Istinye University at 1 site in Turkey (Türkiye).
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 5 inclusion and 2 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 10 Feb 2026. 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 Turkey (Türkiye). 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?
Respiratory Distress Observation Scale (RDOS) (time frame: Within the first assessment (Day 1) and repeated measures within 2 hours after baseline assessment). 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 NCT06922292, which also lists 7 linked publications.
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 10 Feb 2026.