| CTRI Number |
CTRI/2023/07/055541 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
23/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [life style modification] |
| Study Design |
Other |
|
Public Title of Study
|
How to deal with gastric reflux in your daily life -Nurses intervention |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Gill |
| Designation |
Student |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no. 107, National Institute of Nursing Education, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9718214760 |
| Fax |
|
| Email |
nehagill29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no. 107, National Institute of Nursing Education (NINE), Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437748011 |
| Fax |
|
| Email |
shrutipgi2011@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no. 107,National Institute of Nursing Education (NINE), Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437748011 |
| Fax |
|
| Email |
shruti2011pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Sciences, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Neha Gill |
| Address |
Room no. 118, National Institute Of Nursing Education, Post Graduate Institute of Medical Education and Research,Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruti |
Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh |
3rd Floor, B Block, Gastroenterology department, New OPD
Chandigarh
CHANDIGARH |
8437748011
shrutipgi2011@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
normal routine medications prescribed by physician
Total intervention is of 3months |
| Intervention |
Nurse-led Intervention |
Counselling session on Lifestyle modifications
-Low fat diet and high fiber diet
-Smoking cessation
-Daily exercise
-Maintaining 3hrs gap between meal time and bed time
Demonstration of
- Diaphragmatic breathing - Different sleeping postures
Total intervention duration is of 3months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All clinically diagnosed patients of GERD
Patients who are willing to participate |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the effect of intervention on the intensity and frequency of the symptoms of gastroesophageal reflux disease |
At baseline, 6weeks and 12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| – Effect on Proton pump inhibitor usage among patients with GERD. |
outcomes will be assessed at baseline, 6weeks & 12weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research
protocol:
Nurse initiated
patient care package:
Nurse-led intervention includes a complete package of instructions and
practice based activities that would be taught to the patients showing
symptomatic GERD.
1.
It involves counselling the patient
regarding lifestyle modifications in day to day life, which includes
1) Dietary
modifications like:
a. Low
fat diet: counsel patients to avoid unsaturated fatty acids like ghee, dalda, meat
and eggs, on a daily basis.
b. High
fiber diet: counsel them to eat food rich in fiber like oats, whole grain,
spinach, fruits etc.
c. Do
not eat street food which is unhygienic or spicy, or leftover food.
d. Do
not drink too much of beverages(tea or coffee) and soda in a day. Not more than
2-3cups/day.
2) Advice
and encourage patients for smoking cessation
3) Daily
active and passive exercises should be carried out 2hrs before or after the
meal.
4) Advice
the patient to maintain atleast 3hrs gap between meal time and sleeping time to
avoid regurgitation of the gastric content.
2.
Demonstration of
procedures like
a.
Diaphragmatic
breathing: it is also known as abdominal breathing. It includes various
steps that need to be taught to the patient and he/she is advised to do this
exercise for 10mins/day.
Ask the patient to
i.
Sit back or lie
down in a comfortable space.
Close
your eyes.
ii.
Place one hand on the chest and
other on the abdomen. The upper hand should not be moved while inhaling.
iii.
Take a deep breath though nose as
if you are smelling a rose for about 4seconds, feel the expansion of the
abdomen and not the chest.
iv.
Hold the breath for 2 seconds
v.
Exhale slowly through mouth by
pursed-lip technique, or by blowing the candle technique for 6seconds.
vi.
Repeat it for 5-10 mins for 4-5
times /day
b.
Different
sleeping postures:
– Demonstrate
the patient about how the head of the bed is elevated at 30’.
– Left
lateral position is recommended to reduce the acidic reflux. |