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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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