- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517926
Chewing Gum and Cold Gargle on Post-Bronchoscopy Symptoms
The Effect of Chewing Gum and Gargling With Cold Water on Post-Bronchoscopy Sore Throat, Dysphagia, and Patient Satisfaction: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Implementation and Procedures
All patients in the intervention and control groups will be informed about the study's purpose. Patients undergoing bronchoscopy receive routine verbal education from bronchoscopy nurses. In addition to routine education, the intervention groups will receive specific instructions from the researchers. Patients will be blinded to their randomization status and study hypotheses. However, researchers will not be blinded as they will perform the interventions. The chewing gum and cold water gargle procedures will be explained and demonstrated to the intervention groups during face-to-face interviews.
Chewing Gum Procedure All patients will follow the hospital's standard pre-procedure fasting protocol (8 hours of fasting). A researcher will be responsible for supervising the chewing gum procedure. Patients in this group will be asked to chew a commercially available sugar-free gum containing xylitol for 15 minutes immediately before the procedure. After 15 minutes of chewing, patients will discard the gum. The researcher will ensure the gum is removed before the patient is admitted for bronchoscopy. Patients will be strictly instructed not to swallow the gum.
Cold Water Gargle Procedure Patients in this group will perform a cold water gargle under the supervision of a researcher 15 minutes before the procedure. Patients will be instructed not to swallow the water. The researcher will prepare the water at a temperature between 8-12°C (refrigerator coldness). Patients will gargle twice for 30 seconds each, approximately 15 minutes before the procedure.
Control Group The control group will receive standard hospital procedures without any additional intervention.
Data Collection and Evaluation Sore throat, difficulty swallowing (dysphagia), and patient satisfaction levels will be evaluated before the procedure, and at the 2nd and 24th hours post-procedure. The 24-hour evaluation will be conducted via telephone by the research team.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Neriman Yükseltürk Şimşek, PHD
- Phone Number: 0312 3042242
- Email: nerimansimsek@ankara.edu.tr
Study Locations
-
-
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Ankara, Turkey (Türkiye), 06010
- Recruiting
- Gulhane Training and Research Hospital
-
Contact:
- Neriman Yükseltürk Şimşek, PHD
- Phone Number: 03123042242
- Email: nerimansimsek@ankara.edu.tr
-
Sub-Investigator:
- Ferdağ Bölükbaş, PHD
-
Sub-Investigator:
- yakup aslan, md
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Being 18 years of age or older
- Having a scheduled diagnostic bronchoscopy
- Having normal speech and swallowing functions
- Being conscious and able to communicate
- Volunteering to participate in the study
Exclusion Criteria:
• Complications during bronchoscopy
- Gastroesophageal reflux
- Use of non-steroidal anti-inflammatory drugs
- Receiving steroid treatment within 1 week prior to the procedure
- Active infection or disease in the mouth or throat area
- History of allergy or intolerance to the procedure
- Previous anatomical or functional impediment to chewing gum or gargling
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chewing Gum Group
Patients in this group will chew sugar-free xylitol gum for 15 minutes immediately before bronchoscopy.
|
Patients will chew sugar-free xylitol gum for 15 minutes immediately before the bronchoscopy procedure
|
|
Experimental: Cold Water Gargle Group
Patients in this group will gargle with cold water (8-12°C) twice for 30 seconds each, 15 minutes before bronchoscopy.
|
Patients will gargle with cold water (8-12°C) twice for 30 seconds each, 15 minutes before the bronchoscopy procedure.
|
|
No Intervention: Control Group
Patients in this group will receive standard care without additional interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of Post-Bronchoscopy Sore Throat
Time Frame: Baseline (pre-procedure), 2nd hour, and 24th hour post-procedure.
|
Sore throat severity will be measured using a Visual Analog Scale (VAS), where 0 represents 'no pain' and 10 represents 'the most severe pain imaginable.' Higher scores indicate greater pain severity.
|
Baseline (pre-procedure), 2nd hour, and 24th hour post-procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of Post-Bronchoscopy Dysphagia
Time Frame: Baseline (pre-procedure), 2nd hour, and 24th hour post-procedure.
|
Dysphagia severity will be measured using a Visual Analog Scale (VAS), where 0 represents "no difficulty swallowing" and 10 represents "extreme difficulty swallowing."
Higher scores indicate greater difficulty swallowing
|
Baseline (pre-procedure), 2nd hour, and 24th hour post-procedure.
|
|
Patient Satisfaction Level
Time Frame: 2nd hour and 24th hour post-procedure.
|
Patient satisfaction with the procedure and post-operative comfort will be measured using a satisfaction scale (e.g., 0-10 scale or a specific survey).
Higher scores indicate higher satisfaction levels.
|
2nd hour and 24th hour post-procedure.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: neriman yükseltürk şimşek, ankara u
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Respiratory Tract Infections
- Infections
- Respiratory Tract Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Esophageal Diseases
- Otorhinolaryngologic Diseases
- Pharyngeal Diseases
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Deglutition Disorders
- Pharyngitis
- Patient Satisfaction
- Food
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Carbohydrates
- Polymers
- Macromolecular Substances
- Polysaccharides
- Biological Products
- Complex Mixtures
- Biopolymers
- Plant Gums
- Plant Exudates
- Candy
- Chewing Gum
Other Study ID Numbers
- 2025/177
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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