The effect of probiotic on mood status and sleep quality in menopausal wome

Phase 3

Conditions: Menopause.
Menopausal and perimenopausal disorder, unspecified
N95.9

Registration Number: IRCT20120718010324N57

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 66

Inclusion Criteria

Passing of one year from the last menstrual period after the onset of natural menopause
Age 45-60 years
Women who have been passed lower than 5 years from menopause.
Not taking of sleeping drugs and antidepressants, tobacco and alcohol
Obtaining anxiety score 8-19 (mild, moderate and severe anxiety), depression score between 10-27 (mild, moderate and severe depression), stress score between 15-35 (mild, moderate and severe stress) from DASS questionnaire and obtaining a score above 5 from the Pittsburgh Questionnaire.
Having a contact number to follow up
Being resident in Tabriz
Not having digestive problems, asthma, allergies to certain plants, etc. according to the person herself
Having a file in the health center (SIB system)

Exclusion Criteria

Having a history of any physical or mental illness that causes sleep disorders and depression
Existence of hypothyroidism or hyperthyroidism
Having a habit for caffeine consumption
Experiencing an unfortunate event in the last three months, including the death of a loved one that causes sleep disorders, depression and stress

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression, anxiety and stress. Timepoint: Before and 6 weeks after the inervention. Method of measurement: DASS-21 (Depression, Anxiety and Stress Scale-21).;Sleep quality. Timepoint: Before and 6 weeks after the intervention. Method of measurement: Pittsburgh Sleep Quality Index.

Secondary Outcome Measures

Name	Time	Method
Quality of Life. Timepoint: Before and 6 weeks after the Intervention. Method of measurement: Menopause-specific Quality of Life Questionnaire (MENQOL).