| CTRI Number |
CTRI/2024/06/068606 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing prevalence of headache among nursing and paramedical students |
|
Scientific Title of Study
|
A descriptive study to assess the prevalence of headache ,its characteristics, impact and management approaches among nursing and medical student |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahak |
| Designation |
MSc. Nursing Student |
| Affiliation |
college of nursing AIIMS New delhi |
| Address |
College of Nursing, Near old OT Block , AIIMS, Ansari Nagar,new delhi
New Delhi
DELHI
110029
India |
| Phone |
79880300344 |
| Fax |
|
| Email |
Mahaksriswal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Manju AK Rajora |
| Designation |
Associate professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Ground floor, room no.1, College of Nursing AIIMS,Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
sweetie.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Manju AK Rajora |
| Designation |
Associate professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Ground floor, room no.1, College of Nursing AIIMS,Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
sweetie.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, AIIMS , New Delhi, India , Pin code- 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
College of Nursing, AIIMS , New Delhi, India , Pin code- 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manju AK Rajora |
AIIMS New Delhi |
Room no.1 Porta Cabin ,College of Nursing AIIMS New Delhi
New Delhi
DELHI |
9870260036
sweetie.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Assessing Prevalence of headache |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Students willing to take part in the study.
Students of BSc. (H) Nursing 1st year to Nursing 4th year and BSc. Optometry 1ST Year -optometry 4th year |
|
| ExclusionCriteria |
| Details |
Students who having chronic diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the prevalence of headache among nursing and paramedical students
2.To assess the characteristics of headache among nursing and paramedical students.
3.To assess the impact of headache on daily activities and academic performance among nursing and paramedical student
4.To assess the self-care management approaches used by nursing students and paramedical students for headache. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find relationship between severity of headache & academic performance
2.To find association between severity of headache & selected variable. |
at baseline. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/08/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Nursing students face a considerable pressure in terms of academic and clinical requirement.
Stress is a known predisposing factor for headache. Various studies have highlighted the interference of headache with academic and personal lives of students.
This study can be used to assess whether or not their the amount of coursework cause their headaches, as well as how much headaches negatively affect their academic performance (e.g., grades).
Therefore, there is a need to investigate the characteristics and management of headache pain between paramedical and nursing students.
|