Effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation Among Patients Undergoing Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients with complete intake of PEG solution (2 litre) in both groups
研究概览
简要总结
Problem statement An Experimental Study to assess the effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation among Patients Undergoing Colonoscopy at ILBS, New Delhi.
Objectives of the study
The objectives of the study are:
Primary objective
- To compare the effect of gum chewing in experimental vs. control groups in terms of PEG Related Intake Adherence, GI side effects and Bowel Preparation among Patients Undergoing Colonoscopy.
Secondary objective
- To find the relationship of total amount of fluid taken with GI side effects and Bowel Preparation variables in patients undergoing colonoscopy under experimental group.
- To determine the association of PEG Related Intake Adherence, GI side effects and Bowel Preparation among Patients with socio-demographic and clinical variables in patients undergoing colonoscopy under experimental group.
详细描述
Aim of the study To evaluate the effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation among Patients Undergoing Colonoscopy at ILBS, New Delhi.
Operational Definitions
Assess:
In this study, Assess refers to evaluating the effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation among Patients Undergoing Colonoscopy at ILBS, New Delhi.
Effectiveness:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OPD Patients who -
- •Have been planned for elective colonoscopy for therapeutic and/or diagnostic purposes.
- •Have been prescribed PEG solution for bowel preparation.
- •Are able to chew gum.
- •Are willing to participate in the study.
- •Can read and write English or Hindi.
排除标准
- •Patients who -
- •Are critically ill.
- •Are on anti-emetic therapy.
- •Have some psychiatric issues making them unable to follow the instructions.
研究组 & 干预措施
Chewing gums with PEG solution
The investigator provide the chewing gums with PEG solution to the experimental group.
干预措施: Chewing gums with PEG solution (Other)
Standard of Care
Care provided as per the standard existing routine.
干预措施: Standard of care (Other)
结局指标
主要结局
Number of patients with complete intake of PEG solution (2 litre) in both groups
时间窗: up to 5 weeks
Intake Adherence among Patients Undergoing Colonoscopy was assessed by Intake Adherence tool comprises of 4 items which include time spent in ingesting the whole PEG solution in minutes, total amount of PEG solution taken, extra fluid taken other than PEG solution, total amount of fluid taken in milliliters.
Number of patients with change in GI side effects related to PEG solution in both groups
时间窗: up to 5 weeks
GI side effects among Patients Undergoing Colonoscopy was assessed by Numerical Rating Scale and the Rhodes Index of Nausea, Vomiting, And Retching (INVR).
Improvement in bowel preparation in both groups
时间窗: up to 5 weeks
Bowel Preparation among Patients Undergoing Colonoscopy was assessed by Boston Bowel Preparation Scale. A four-point scoring system with maximum score of 9 and minimum score of 0 applied to each of the three broad regions of the colon: the right colon (including the cecum and ascending colon), the transverse colon (including the hepatic and splenic flexures), and the left colon (including the descending colon, sigmoid colon, and rectum).
次要结局
未报告次要终点