Clinical trial NCT06922292: "Turkish Validation of the Respiratory Distress Observation Scale in Palliative Care"
Official title: Adaptation, Validity, and Reliability of the Respiratory Distress Observation Scale in Adult Palliative Care Patients: A Turkish Version
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dyspnea
Palliative Care
Reliability and Validity
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Completely dependent on a ventilator,
* Diagnosed with a central nervous system disorder (Quadriplegia, Bulbar ALS).

Primary outcomes:
measure: Respiratory Distress Observation Scale (RDOS)
timeFrame: Within the first assessment (Day 1) and repeated measures within 2 hours after baseline assessment
Secondary outcomes:
measure: Heart Rate Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Systolic Blood Pressure Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Diastolic Blood Pressure Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Respiratory Rate Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Oxygen Saturation Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Body Temperature Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Partial Pressure of Oxygen (PaO₂) Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Partial Pressure of Carbon Dioxide (PaCO₂) Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Arterial Oxygen Saturation (SaO₂) Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Blood pH Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Bicarbonate (HCO₃-) Assessment
timeFrame: Within 30 minutes prior to RDOS administration
measure: Dyspnea Assessment
timeFrame: At baseline
measure: ICU Stay Duration
timeFrame: At enrollment
measure: Glasgow Coma Scale (GCS) Assessment
timeFrame: At enrollment
measure: Clock Drawing Test Assessment
timeFrame: At enrollment
measure: Palliative Performance Scale (PPS) Score Assessment
timeFrame: At enrollment
measure: Type of Respiratory Support Assessment
timeFrame: At enrollment
measure: Fraction of Inspired Oxygen (FiO₂) Assessment
timeFrame: At baseline
measure: PaO₂/FiO₂ Ratio Assessment
timeFrame: At baseline
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istınye University, Istanbul,
Study officials:
References:
citation: 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.
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