"Turkish Validation of the Respiratory Distress Observation Scale in Palliative Care"

NCT06922292 | Completed

• 1 other identifier: ISU-2025-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea; Palliative Care; Reliability and Validity

Outcome Measures

Primary Outcomes (1)

• 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.

  Within the first assessment (Day 1) and repeated measures within 2 hours after baseline assessment

Secondary Outcomes (19)

• Heart Rate Assessment

  Within 30 minutes prior to RDOS administration

• Systolic Blood Pressure Assessment

  Within 30 minutes prior to RDOS administration

• Diastolic Blood Pressure Assessment

  Within 30 minutes prior to RDOS administration

• Respiratory Rate Assessment

  Within 30 minutes prior to RDOS administration

• Oxygen Saturation Assessment

  Within 30 minutes prior to RDOS administration

Study Arms (1)

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.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istınye University, Istanbul,

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 33633100 BACKGROUND

• Pianosi 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.

  PMID: 26770885 BACKGROUND

• Eakin 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.

  PMID: 9515834 BACKGROUND

• Parshall 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.

  PMID: 22336677 BACKGROUND

• Ambrosino N, Porta R. Measurement of dyspnoea. Monaldi Arch Chest Dis. 2001 Feb;56(1):39-42.

  PMID: 11407208 RESULT

• Dyspnea. 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.

  PMID: 9872857 RESULT

• Coccia 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.

  PMID: 26933707 RESULT

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: February 1, 2025
• Primary Completion: May 20, 2025
• Study Completion: May 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)