| CTRI Number |
CTRI/2024/11/077443 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on digestive health and eating habits of female nurses from Mumbai |
|
Scientific Title of Study
|
Assessment of upper gastro-intestinal health and dietary habits of female nurses from Mumbai City |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Sanwalka Rungta |
| Designation |
Associate Professor |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune |
| Address |
Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8108009900 |
| Fax |
|
| Email |
neha.sanwalka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Gayatri Sawant |
| Designation |
Student |
| Affiliation |
Dr BMN College of Homescience |
| Address |
Dr BMN College of Homescience, Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8425032495 |
| Fax |
|
| Email |
sawantgayatrig@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Sanwalka Rungta |
| Designation |
Associate Professor |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune |
| Address |
Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8108009900 |
| Fax |
|
| Email |
neha.sanwalka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College of Homescience, Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai,Maharashtra, India, 400019 |
|
|
Primary Sponsor
|
| Name |
Ms Gayatri Gokul Sawant |
| Address |
Dr BMN College of Homescience Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra, India, 400019 |
| 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 Neha Sanwalka |
Dr BMN College of Homescience |
Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai-400019, Maharashtra, India
Mumbai
MAHARASHTRA |
8108009900
neha.sanwalka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee (EIC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female nurses aged 20-60 years. Employed in hospitals in Mumbai. Working for over a year and willing to participate. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All the female Nurses fall under the age group of 20 to 60 years old.
Female nurses that work at hospitals in Mumbai city.
Nurses who were employed for more than one year and willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Doctors or any other healthcare workers.
Nurses who were employed for more than one year but not willing to participate in the study.
Retired Nurses
Male nurses |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Identification of the eating habits of nurses working in multiple shifts |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2.Insights into the factors influencing nurses food preferences and eating habits in relation with their shift work.
3.The data from the current study can be used to develop a training program to help nurses manage their health and dietary habits better. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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
|
The prevalence of upper GI disorders and dietary habits of female nurses in Mumbai City will be assessed in this study. Female nurses aged between 20 to 60 years with over one year of experience in hospitals were involved in this cross-sectional survey. This study thus aimed at evaluating the effects of long working hours and dietary patterns on upper GI health in Nurses.
120 nurses were surveyed through a structured questionnaires. Data collection from the nurses included some information on dietary habits, lifestyle practices and the pattern of gastrointestinal complaints, thereby gaining some understanding of the professional and lifestyle factors underlying the health conditions prevalent among the nurses.
It would help with what diet or lifestyle interventions could be employed to improve health within nursing staff and contribute generally to the knowledge of occupational health among healthcare professionals. |