| CTRI Number |
CTRI/2023/04/051401 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
13/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes Other (Specify) [Health promotional] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Combo Therapy on Migraine among nursing students |
|
Scientific Title of Study
|
Effectiveness of Combo Therapy on migraine among female nursing students in selected nursing college, Bhubaneswar- A randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pamela Majumder |
| Designation |
M.Sc Nursing student |
| Affiliation |
Kalinga Institute of Nursing Sciences |
| Address |
KALINGA INSTITUTE OF NURSING SCIENCES, KIIT- DU, BHUBANESWAR, ODISHA
Khordha ORISSA 751024 India |
| Phone |
7609066289 |
| Fax |
|
| Email |
pamela.majumder98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
MR ASOKAN R |
| Designation |
PROFESSOR, HOD, MEDICAL SURGICAL NURSING, I/C R&D CELL, KINS, KIIT-DU |
| Affiliation |
Kalinga Institute of Nursing Sciences |
| Address |
KALINGA INSTITUTE OF NURSING SCIENCES, KIIT-DU, BHUBANESWWAR, ODISHA
Khordha ORISSA 751024 India |
| Phone |
7008326128 |
| Fax |
|
| Email |
asokan@kins.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Pamela Majumder |
| Designation |
M.Sc Nursing student |
| Affiliation |
Kalinga Institute of Nursing Sciences |
| Address |
KALINGA INSTITUTE OF NURSING SCIENCES, KIIT-DU, BHUBANESWAR, ODISHA
Khordha ORISSA 751024 India |
| Phone |
7609066289 |
| Fax |
|
| Email |
pamela.majumder98@gmail.com |
|
|
Source of Monetary or Material Support
|
| KALINGA INSTITUTE OF NURSING SCIENCES, KIIT-DU, BHUBANESWAR, ODISHA
Lord Jagannath Mission College of Nursing, Mancheswar, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Pamela Majumder |
| Address |
KIMS GIRLS HOSTEL, BLOCK B, CAMPUS 5, KIIT UNIVERSITY |
| 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 |
| Pamela Majumder |
KALINGA INSTITUTE OF NURSING SCIENCES |
KALINGA INSTITUTE OF NURSING SCIENCEES, DEPARTMENT OF MEDICAL SURGICAL NURSING,1st floor, Room no 1, Common hall room,KIIT UNIVERSITY,PATIA, BHUBANESWAR Khordha ORISSA |
7609066289
pamela.majumder98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
FEMALE NURSING STUDENTS WITH MIGRAINE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COMBO THERAPY |
In this study it refers to a combination of Aerobic exercises, Progressive muscle relaxation exercises and a Health Education in order to get a instant relief from migraine pain.
Combo therapy will be given 40 minutes once a day for 3 weeks and 3 alternative days a week. |
| Comparator Agent |
THERAPEUTIC HEALTH EDUCATION |
Health education will be given as a self-management program with multimodal formats including verbal, video materials.
Health education will be given to the participants for 10 minutes once a day for 3 weeks and 3 alternative days a week.
To prevent migraines
Keep a headache diary so you can figure out what triggers your headaches.
If your doctor has prescribed medicine for your migraines, take it as directed.
Find healthy ways to deal with stress.
Get plenty of sleep and exercise. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
01. Female nursing students with migraine
02. Students between the age group of 18-30 years |
|
| ExclusionCriteria |
| Details |
1. Students with any other illness (Cardiac diseases, Asthma, Gastritis, Any physical deformity)
2. Students those who are not willing to participate
3. Students those who are not able to do breathing exercises |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of migraine headache among female nursing students with migraine. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of headache impact score and increased self efficacy score to manage pain among female nursing students with migraine |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="74" Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2023 |
| Date of Study Completion (India) |
28/09/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Migraine is a headache that can cause severe throbbing pain or a pulsing sensation, usually on one side of the head. It’s often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. Combo Therapy is a combination of Aerobic exercises, Progressive muscle relaxation exercises and a Health Education in order to get a instant relief from migraine pain. Aerobics is a form of physical exercise that combines rhythmic aerobic exercise with stretching and strength training routines with the goal of improving all elements of fitness. Progressive muscle relaxation (PMR) is a relaxation technique. It involves tensing and then relaxing your muscles, one by one. This helps you release physical tension, which may ease stress and anxiety. Research has shown that PMR offers a range of benefits, including pain relief and better sleep. Health education will be given as a self-management program with multimodal formats including verbal, video materials. Before data collection, screening will be done by using structured ICHD scale of diagnosing migraine for selection of the population, By using simple random sampling method participants will be assigned in the experimental and control group. Informed consent will be taken from all the subjects after explaining the purpose of the study. Assessment will be conducted by using structured questionnaire for both groups. Combo therapy will be given 40 minutes once a day for 3 weeks and 3 alternative days a week. Outcome will be evaluated on the 4th week on the same female nursing students for checking the effectiveness of combo therapy. Post test will be conducted after administrating the therapy using structured questionnaire for both groups. The data collected will be tabulated and analyzed after that |