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CTRI Number  CTRI/2021/02/031257 [Registered on: 12/02/2021] Trial Registered Prospectively
Last Modified On: 10/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the effect of Mindfulness Based Cognitive behavioral therapy on premenstrual symptoms,Blood Pressure,Blood Glucose Level,Depression,Work an Social Adjustment among working women  
Scientific Title of Study   A study to Evaluate the Effectiveness of Mindfulness Based Cognitive behavioural therapy on premenstrual symptoms,Blood Pressure,Blood Glucose Level,Depression,Work an Social Adjustment among women working in selected organisation at Kalaburagi, Karnataka. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bemina J A 
Designation  Assisstant Professor 
Affiliation  ESIC College of nursing 
Address  ESIC College of Nursing,ESIC Medical College Campus,Sedam Road Kalaburagi

Gulbarga
KARNATAKA
585106
India 
Phone  9886675333  
Fax    
Email  beminaja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Thereza Mathias 
Designation  Professor and HOD Psychiatry 
Affiliation  RGUHS ,Bangalore 
Address  Laxmi Memorial College of Nursing A J Tower Balmatta Mangaluru

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9902597730  
Fax    
Email  tresavinay@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Bemina J A 
Designation  Assisstant Professor 
Affiliation  ESIC College of nursing 
Address  ESIC College of Nursing ,ESIC Medical College Campus,Sedam Road Kalaburagi

Gulbarga
KARNATAKA
585106
India 
Phone  9886675333  
Fax    
Email  beminaja@gmail.com  
 
Source of Monetary or Material Support  
All Government schools of Gulbarga  
 
Primary Sponsor  
Name  Bemina J A 
Address  ESIC College Of Nursing ESIC Medical College Campus,Sedam Road, Kalaburagi 585106 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
DR Thereza Mathias  Professor and HOD Psychiatry Nursing Department Laxmi Memorial College of Nursing AJ Tower Belmata Mangalore 02 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SPBADAGANDI  Government Schools Under DDPI  DDPI,Mini Vidhanasoudha Campus,Timmapuri Chock,Gulbarga 585105
Gulbarga
KARNATAKA 
08472278625
08472220186
ddpigulbarga32@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AJ INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTER, MANGALURU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Premenstrual symptoms,Blood Pressure,Blood Glucose level,Work and Social Adjustment 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Intervention Standard Self Routine  The control group sample will receive their regular treatment and other self routines  
Intervention  MCBT Mindfulness Based Cognitive Behavioral therapy  Mindfulness Based Cognitive Behavioral Therapy will be given to the experimental group. It is an approach to psychotherapy that uses cognitive behavioral therapy methods in collaboration with mindfulness meditative practices and similar psychological strategies which helps the participants to identify and accept the negative thought pattern and response in intentional ways to gain freedom from automatic reactions to thoughts, feelings and events. The main contents of interventions includes . 1. Introduction. 2. Identifying Premenstrual symptoms and associate thinking errors. 3. Cognitive restructuring. 4. Behavioral modification. 5. Effective coping mechanism. 6. Mindfulness techniques. 7. Meditation techniques. 8.Education on lifestyle modification. Intervention will be delivered in group approach. Each group will consist of 3-4 members. Intervention will be given for 2 months in eight sessions, one session per week with the duration of 30 minutes respectively.  
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  1.Aged between 22 to 49 years.
2.women married
3.Women who have regular menstrual cycle.
4.Women who are having the PMSS score of above 40.
 
 
ExclusionCriteria 
Details  Women who are
1.Diagnosed with polycystic ovarian disease.
2.In lactation amenorrhea.
3.With oral contraceptives.
4.Diagnosed with pelvic inflammatory diseases.
5.Diagnosed with diabetes and hypertensive disorders.
6.Working in health organisations.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in PMS Premenstrual Symptom Scale. (PMSS) and depression using
Hamilton Depression (HAM-D) Rating Scale  
0 2 month 4 month 6 month Follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Blood Pressure,Blood Glucose Level Work and Social Adjustment  0,2 months,4 months,6 months 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   03/05/2021 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [beminaja@gmail.com].

  6. For how long will this data be available start date provided 03-05-2021 and end date provided 09-03-2021?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is a randomized control trail, parallel group evaluating the effectiveness of MCBT on Premenstrual symptoms ,Depression, Blood Pressure, Blood Glucose level, work and social adjustment among women’s working in selected organizations at Kalaburagi .The primary outcome measures assessment of PMS and Depression will be done by using the following at 0,2 month,4 month and 6 month.

Premenstrual Symptom Scale. (PMSS) It  is comprised of 40 questions with three subscales (physiological, psychological and behavioral symptoms) ,it is a five point Likert type scale varying from no symptoms  to  very severe. This scale consists of forty items are measured according to the following scoring system. Each item is scored from 0-5. PMSS has a validity of 0.81 and a reliability of 0.97.      

Hamilton Depression Rating Scale The total Hamilton Depression (HAM-D) Rating Scale provides and indication of depression and, over time, provides a valuable guide to progress. It has a good reliability 0.83 and excellent internal consistency cronbachs alpha 0.92 In general the higher the total score the more sever the depression. HAM-D score level of depression:10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe.

The secondary outcomes are assessed using the below tools at 0, 2 month,4 month and 6 month

Blood pressure assessment will be done by using  a SphygmomanometerReliability of the instrument will be calculated by test retest method. Checklist will be prepared for recording the blood pressure.

Systolic blood pressure Normal  100 to140 mm of Hg ,Mild hypertension 141 to 160 mm of Hg,Moderate Hypertension 161 to 180 mm of Hg,Severe Hypertension 181 to 210 mm of Hg

Diastolic blood pressure Normal 60 to 90 mm of Hg,Mild Hypertension 91 to 100 mm of Hg,Moderate Hypertension 101 to 110 of Hg,Severe Hypertension 111 to120 mm of Hg

 Blood glucose level only FBS will be assessed by using glucometer. Reliability of the instrument will be calculated by test retest method. Checklist will be prepared for recording the glucose level in the blood.

Fasting Blood Sugar Normal  90 - 120 mg/dl ,Medium 121 -160 mg/dl,High 161- 240mg/dl ,Too high 241 - 300 mg/dl Very High  above 301mg 

 Work and Social Adjustment Scale (WSAS) is a simple and reliable measure for impairment in functioning. In this study it assesses the impact of a woman, mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure and personal or family relationships. This instrument has 5 items ,internal scale consistency ranged from 0.70 to 0.94.

Scoring 0-9  No impairment to Low impairment,10-19 Moderate impairment,20-40 severe impairment.

 
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