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

Not yet recruiting

Conditions: Premenstrual symptoms,Blood Pressure,Blood Glucose level,Work and Social Adjustment
Diseases of the genitourinary system, (2) ICD-10 Condition: PCS||,

Registration Number: CTRI/2021/02/031257

Lead Sponsor: Bemina J A

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 womenâ€™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 pressureNormal 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 pressureNormal 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 SugarNormal 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 160

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in PMS Premenstrual Symptom Scale. (PMSS) and depression using	0 2 month 4 month 6 month Follow up
Hamilton Depression (HAM-D) Rating Scale	0 2 month 4 month 6 month Follow up

Secondary Outcome Measures

Name	Time	Method
Reduction in Blood Pressure,Blood Glucose Level Work and Social Adjustment	0,2 months,4 months,6 months

Trial Locations

Locations (1): Government Schools Under DDPI
🇮🇳
Gulbarga, KARNATAKA, India
Government Schools Under DDPI
🇮🇳Gulbarga, KARNATAKA, India
SPBADAGANDI
Principal investigator
08472278625
ddpigulbarga32@gmail.com