A randomized control trial to assess the effectiveness of Nurse-led intervention on symptoms of Gastroesophageal reflux disease on selected outcome variables among patients with Gastroesophageal reflux disease attending Gastro OPD, PGIMER Chandigarh.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- to assess the effect of intervention on the intensity and frequency of the symptoms of gastroesophageal reflux disease
研究概览
简要总结
Researchprotocol:
Nurse initiatedpatient care package:
Nurse-led intervention includes a complete package of instructions andpractice based activities that would be taught to the patients showingsymptomatic GERD.
1. It involves counselling the patientregarding lifestyle modifications in day to day life, which includes
1) Dietarymodifications like:
a. Lowfat diet: counsel patients to avoid unsaturated fatty acids like ghee, dalda, meatand eggs, on a daily basis.
b. Highfiber diet: counsel them to eat food rich in fiber like oats, whole grain,spinach, fruits etc.
c. Donot eat street food which is unhygienic or spicy, or leftover food.
d. Donot drink too much of beverages(tea or coffee) and soda in a day. Not more than2-3cups/day.
2) Adviceand encourage patients for smoking cessation
3) Dailyactive and passive exercises should be carried out 2hrs before or after themeal.
4) Advicethe patient to maintain atleast 3hrs gap between meal time and sleeping time toavoid regurgitation of the gastric content.
2. Demonstration ofprocedures like
a. Diaphragmaticbreathing: it is also known as abdominal breathing. It includes varioussteps that need to be taught to the patient and he/she is advised to do thisexercise for 10mins/day.
Ask the patient to
**i.**Sit back or liedown in a comfortable space.Closeyour eyes.
**ii.**Place one hand on the chest andother on the abdomen. The upper hand should not be moved while inhaling.
**iii.**Take a deep breath though nose asif you are smelling a rose for about 4seconds, feel the expansion of theabdomen and not the chest.
**iv.**Hold the breath for 2 seconds
**v.**Exhale slowly through mouth bypursed-lip technique, or by blowing the candle technique for 6seconds.
**vi.**Repeat it for 5-10 mins for 4-5times /day
**b.**Differentsleeping postures:
– Demonstratethe patient about how the head of the bed is elevated at 30’.
– Leftlateral position is recommended to reduce the acidic reflux.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All clinically diagnosed patients of GERD Patients who are willing to participate.
排除标准
- •Patients with prior esophageal surgery.
- •Patients having other serious medical conditions along with GERD such as esophageal stricture, barrett’s metaplasia, peptic ulcers, oesophageal cancer.
结局指标
主要结局
to assess the effect of intervention on the intensity and frequency of the symptoms of gastroesophageal reflux disease
时间窗: At baseline, 6weeks and 12weeks
次要结局
- –Effect on Proton pump inhibitor usage among patients with GERD.(outcomes will be assessed at baseline, 6weeks & 12weeks)