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临床试验/NCT07517926
NCT07517926招募中不适用

The Effect of Chewing Gum and Gargling With Cold Water on Post-Bronchoscopy Sore Throat, Dysphagia, and Patient Satisfaction: A Randomized Controlled Study

Ankara University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Severity of Post-Bronchoscopy Sore Throat

研究概览

简要总结

This study aims to evaluate the effects of chewing gum and gargling with cold water on common post-bronchoscopy symptoms, such as sore throat and difficulty swallowing (dysphagia). Bronchoscopy is a procedure that can cause temporary throat discomfort. In this randomized controlled trial, patients will be divided into groups to receive either chewing gum, cold water gargle, or standard care. The researchers will then measure and compare patient satisfaction levels and the severity of throat symptoms to determine if these simple interventions can improve patient comfort after the procedure.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Patients are blinded to their group assignment and study hypotheses. Researchers administering the interventions are not blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 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

排除标准

  • • 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

研究组 & 干预措施

Chewing Gum Group

Experimental

Patients in this group will chew sugar-free xylitol gum for 15 minutes immediately before bronchoscopy.

干预措施: Chewing Gum (Behavioral)

Cold Water Gargle Group

Experimental

Patients in this group will gargle with cold water (8-12°C) twice for 30 seconds each, 15 minutes before bronchoscopy.

干预措施: Cold Water Gargle (Behavioral)

Control Group

No Intervention

Patients in this group will receive standard care without additional interventions.

结局指标

主要结局

Severity of Post-Bronchoscopy Sore Throat

时间窗: 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.

次要结局

  • Severity of Post-Bronchoscopy Dysphagia(Baseline (pre-procedure), 2nd hour, and 24th hour post-procedure.)
  • Patient Satisfaction Level(2nd hour and 24th hour post-procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neriman Yükseltürk Simşek

Assistant Professor

Ankara University

研究点 (1)

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