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Can Words Change Perception? Verbal Counseling and Dry Mouth in COPD Treatment

The Impact of Verbal Counseling on Nocebo-Induced Perception of Tiotropium Bromide-Related Xerostomia Among Patients with Chronic Obstructive Pulmonary Disease: A double-blinded Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250408065249N1
Enrollment
130
Registered
2025-04-12
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic obstructive pulmonary diseases. Other chronic obstructive pulmonary disease

Interventions

Intervention 1: Intervention group: All patients will receive general education on the importance of COPD and the regular use of inhaled medications. They will also be informed that relevant drug info

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of COPD based on clinical criteria and imaging evaluated by a pulmonologist. Diagnosis of airway obstruction based on spirometry within the past six months, according to GOLD criteria. FEV1/FVC ratio below 70% as the criterion for airway obstruction. Age of at least 18 years. Completion of a written informed consent form by the patient.

Exclusion criteria

Exclusion criteria: Pregnant or breastfeeding patients. Patients with concurrent pulmonary diseases such as bronchiectasis or pulmonary fibrosis. Patients taking other anticholinergic medications. Patients with a history of drug allergies to anticholinergic medications. Patients with a history of glaucoma. Patients with uncompensated heart failure, ESRD, or advanced liver failure. Patients with severe psychiatric disorders or Alzheimer’s disease who cannot cooperate.

Design outcomes

Primary

MeasureTime frame
"Determination and Comparison of xerostomia in COPD Patients Using Inhaled Tiotropium in Two Study Groups. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: Persian version of xerostomia inventory (XI).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Hatefi Ardakani

Yazd University of Medical Sciences

ali.hatafi02@gmail.com+98 35 3222 5264

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026