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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [beminaja@gmail.com].
- 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.
- 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 Sphygmomanometer. Reliability 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. |