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CTRI Number  CTRI/2021/02/031538 [Registered on: 25/02/2021] Trial Registered Prospectively
Last Modified On: 12/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Physiotherapy (including YOGA)]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of yoga and exercise on pain, muscle performance, stress and quality of life in primary dysmenorrhea. 
Scientific Title of Study   A comparative study of yoga and structured exercises on pain, muscle performance, stress and quality of life in primary dysmenorrhea 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivani Ahuja PT 
Designation  Post Graduate student 
Affiliation  Amar Jyoti Institute of Physiotherapy 
Address  2nd floor, Physiotherapy department, Amar Jyoti Institute of Physiotherapy Karkardooma, Vikas marg, New Delhi

East
DELHI
110092
India 
Phone  9968370588  
Fax    
Email  shivani.ahuja50@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jeyanthi S PT 
Designation  Associate Professor 
Affiliation  Amar Jyoti Institute of Physiotherapy 
Address  2nd floor, Physiotherapy department, Amar Jyoti Institute of Physiotherapy Karkardooma, Vikas marg, New Delhi

East
DELHI
110092
India 
Phone  9958158815  
Fax    
Email  jeyanthi.s@ajipt.org  
 
Details of Contact Person
Public Query
 
Name  Dr Jeyanthi S PT 
Designation  Associate Professor 
Affiliation  Amar Jyoti Institute of Physiotherapy 
Address  2nd floor, Physiotherapy department, Amar Jyoti Institute of Physiotherapy Karkardooma, Vikas marg, New Delhi

East
DELHI
110092
India 
Phone  9958158815  
Fax    
Email  jeyanthi.s@ajipt.org  
 
Source of Monetary or Material Support  
SELF Amar jyoti institute of physiotherapy, Karkardooma, Vikas marg, New delhi-110092 
 
Primary Sponsor  
Name  Amar jyoti institute of physiotherapy 
Address  karkardooma, Vikas marg, New Delhi-110092 
Type of Sponsor  Private medical college 
 
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 
Shivani Ahuja  Amar jyoti institute of physiotherapy  2nd floor, Physiotherapy department, Amar jyoti institute of physiotherapy, Karkardooma, Vikas marg, New Delhi - 110092
East
DELHI 
9968370588

shivani.ahuja50@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amar Jyoti Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Yoga to Group 1 and Structured Exercise to Group 2  In this study we will compare yoga and structured exercises which are two alternative methods that can be used to manage symptoms of primary dysmenorrhea. We will be assessing strength of the abdominal muscles using pressure biofeedback unit, muscle power by front power abdominal test, flexibility using sit and reach test, endurance using abdominal static endurance test and beiring sorensen test. We will use short form 36 questionnaire to assess quality of life, visual analog scale to assess pain intensity and perceived stress scale 10 to assess stress levels in the participants with primary dysmenorrhea. Participants in yoga group will perform asanas like uttanpadasana, uttanasana, sasankasana, salabhasana, chakkichalanasana and dhanurasana. Participants in structured exercise group will perform curl ups, pelvic bridging, plank exercises, trunk extension,bilateral knee to chest, hamstring stretching. After the treatment two post tests using the outcome measures mentioned above will be conducted on the third day of second and third menstrual cycle. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  WaLIDD Score more than or equal to 1.
Only female subjects with regular menstrual cycles (i.e. 25 to 35 days).
Pain intensity of 4 or above in visual analog scale.
Students with only primary dysmenorrhea.
Willing to participate in the study voluntarily by signing informed consent.
Working knowledge of english. 
 
ExclusionCriteria 
Details  Students who are not willing to participate.
Using pharmacological or non-pharmacological methods for pain relief during study.
Irregular menstrual cycles.
History of regular exercises or yoga 3 days/week.
History of any gynecological disorders or secondary dysmenorrhea .
History of any musculoskeletal/neurological problems like disc prolapse, etc.
History of recent fracture, strain or sprain. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale to assess pain intensity.  Assessed on Day 3 of first, second and third menstrual cycle. It will be assessed three times. 
 
Secondary Outcome  
Outcome  TimePoints 
Pressure biofeedback unit
to measure transversus abdominis muscle strength.

Sit and reach test to assess flexibility.

Front power abdominal test to assess muscle power.

Abdominal static endurance test and beiring sorensen test to assess muscle endurance.

Perceived stress scale - 10 to measure stress levels.

Short form 36 questionnaire to assess quality of life. 
Assessed on Day 3 of first, second and third menstrual cycle. It will be assessed three times. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/03/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Primary dysmenorrhea is defined as painful menses in women with normal pelvic anatomy and regular ovulatory cycles that usually begins during puberty or adolescent phasePrimary dysmenorrhea affects the women at the age of 16-25 years. Menstrual pain starts after 6 to 12 months after menarche, once the cycles are regular. Symptoms last for about 1 - 3 days of menstruation. Primary dymenorrhea is characterized by cramps, aches or dull pain in the supra-pubic region with or without radiation to lower back, abdomen, medial thigh or upper leg. The chief etiological factors as described by previous researches have been psychic and emotional, fatigue, postural defects and weak abdominal muscles. Hollow back and poor abdominal support lead to increased pressure on pelvic organs and a probable impairment of circulation. Therefore, development of the muscles of the abdominal wall is generally recognized because of the role it plays in maintaining a correct body posture and in supporting the organs in the abdominal cavity. Through this study we will try to explore the abdominal muscle strength, power and endurance in women with primary dysmenorrhea. Also in this study we will explore the effect of alternate treatment technique  (ie Yoga and structured exercises) to reduce pain, improve muscle performance, and quality of life in primary dysmenorrhea. Subjects will be allocated randomly into two training groups (yoga and structured exercises)Then a pre - test will be performed on the third day of the menstrual cycle  before beginning with the intervention. Pre - test will involve testing the levels of pain, muscle performance (strength, power, flexibility and endurance), stress and quality of life. Study involves 3 week long intervention period. Then 2 post tests will be conducted on the third day of  second and third menstrual cycles.

 
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