Interoception and Symptom Perception in Acute COPD Exacerbation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorSaglik Bilimleri Universitesi
About this trial
Interoception refers to the process of perceiving and interpreting internal physiological signals and plays a central role in symptom perception. In conditions with a high symptom burden such as chronic obstructive pulmonary disease (COPD), clinical features including dyspnea perception, depression, and sleep quality may be influenced not only by disease severity but also by the interpretation of internal bodily signals.
Recent evidence suggests that respiratory-related internal signals are transmitted to the central nervous system through multiple afferent pathways and integrated within cortical and subcortical networks, contributing to subjective experiences such as dyspnea. In this context, dyspnea perception may arise from the interaction between disease severity and interoceptive processes.
Depressive symptoms and impaired sleep quality are also closely associated with interoceptive processes and may contribute to the perception of respiratory symptoms. However, studies simultaneously examining interoception, disease severity, dyspnea perception, depression, and sleep quality in hospitalized patients with acute COPD exacerbation are limited.
This prospective, observational, cross-sectional study will include 50 individuals aged 40 years and older who are hospitalized with acute COPD exacerbation in a Chest Diseases clinic. Data will be collected at a single time point when patients are clinically stable, without interfering with routine clinical care. Participants will be recruited using a consecutive sampling method.
Sociodemographic and clinical data will be obtained from patient records and a structured data collection form. Disease severity will be assessed using oxygen requirement, respiratory rate, oxygen saturation, and arterial blood gas values when available. Interoception will be evaluated using the Multidimensional Assessment of Interoceptive Awareness (MAIA-2). Symptom burden will be assessed with the COPD Assessment Test (CAT), dyspnea with the Modified Medical Research Council (mMRC) scale, sleep quality with the Richards-Campbell Sleep Questionnaire (RCSQ), and depressive symptoms with the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D).
Statistical analyses will be performed using IBM SPSS Statistics software. Relationships between variables will be analyzed using Pearson or Spearman correlation depending on data distribution, with a significance level of p\<0.05.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Physician-confirmed diagnosis of acute exacerbation of COPD with hospitalization
Age 40 years or older
Conscious and able to communicate
Willing to participate and provide written informed consent
Disqualifiers
Presence of delirium or severe cognitive impairment
Requirement for invasive mechanical ventilation
Clinical instability preventing safe administration of assessment tools
History of severe neurological or psychiatric disorders
Trial population
The study population consists of adults aged 40 years and older who are hospitalized with a physician-confirmed diagnosis of acute exacerbation of chronic obstructive pulmonary disease (COPD) in a Chest Diseases clinic. Participants are recruited using a consecutive sampling method and include individuals who are clinically stable at the time of assessment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionParticipants' sleep quality, COPD symptom burden, dyspnea severity, anxiety and depression levels, and interoceptive processing will be assessed cross-sectionally.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Acute COPD Exacerbation1 intervention
Trial outcomes
Primary outcomes
1
Interoception Assessment
Interoception will be assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA), a validated self-report questionnaire that evaluates multiple dimensions of interoceptive processing, including awareness of bodily sensations, emotional and attentional responses to these sensations, and self-regulation abilities; the MAIA consists of several subscales scored on a Likert-type scale (typically 0-5), with higher scores indicating greater interoceptive awareness in the corresponding domain.
Time frame
baseline2
COPD Symptom Burden Assessment
COPD symptom burden will be assessed using the COPD Assessment Test (CAT), an 8-item patient-reported questionnaire; each item is scored on a 6-point Likert scale (0-5), yielding a total score ranging from 0 to 40, with higher scores indicating greater symptom burden and disease impact.
Time frame
baseline3
Dyspnea Severity Assessment
Dyspnea severity will be assessed using the Modified Medical Research Council (mMRC) scale, a widely used grading system that classifies breathlessness from grade 0 to 4 based on activity limitation, with higher scores indicating more severe dyspnea.
Time frame
baseline4
Sleep Quality Assessment
Sleep quality will be assessed using the Richard-Campbell Sleep Questionnaire (RCSQ), a patient-reported instrument evaluating perceived sleep depth, sleep latency, number of awakenings, sleep efficiency, and overall sleep quality; each item is rated on a visual analog scale (0-100), with higher scores indicating better perceived sleep quality.
Time frame
baselineSponsors and contacts
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Source ClinicalTrials.gov