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The effect of probiotic on mood status and sleep quality in menopausal women: A triple-blind randomised controlled trial

Protocol summary

Study aim
The effect of probiotic on mood status and sleep quality in menopausal women:l
Design
A triple-blind randomized controlled trial
Settings and conduct
This trial will be performed on 66 menopausal women who referring to health centers of Tabriz. Menopausal women will be assessed according to the eligibility criteria and if they have criteria and willingness to participate in the study, the written informed consent will obtained and primary evaluations will be conducted. Participants will be assigned into two groups of probiotic yogurt and ordinary yogurt using block randomization method with block sizes of 4 and 6 and allocation ratio of 1:1.
Participants/Inclusion and exclusion criteria
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, Having mild, moderate and severe anxiety, depression and stress; 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.; Having a file in the health center. Exclusion criteria: Having a history of an y physical or mental illness; Existence of hypothyroidism or hyperthyroidism; Having a habit for caffeine consumption; Experiencing an unfortunate event in the last three months
Intervention groups
The control group will receive 100 gram ordinary yogurt and the intervention group will receive 100 gram probiotic yogurt daily (after lunch) for six weeks.
Main outcome variables
The main outcomes are the mood status and sleep quality.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120718010324N57
Registration date: 2020-06-30, 1399/04/10
Registration timing: prospective

Last update: 2020-06-30, 1399/04/10
Update count: 0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-21, 1399/04/31
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic on mood status and sleep quality in menopausal women: A triple-blind randomised controlled trial
Public title
The effect of probiotic on mood status and sleep quality in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 45 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned into the two intervention groups (probiotic yogurt recipient) and control (ordinary yogurt recipient) by stratified block randomization method (stratification based on the time elapsed passed since the onset of natural menopause; less than 5 years and more than 5 years) with block sizes of 4 and 6 and a 1: 1 allocation ratio. Random sequence will be determined by the person not involved in the sampling and data collection. For Allocation Concealment, the code of yogurt will be written on piece of paper and placed inside the serial numbered envelopes. After obtaining informed consent, the relevant envelope will be opened and the intervention type will be determined.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, researchers, data analysts, and outcome assessors will be blinded due to the fact that the code of the packages of yogurt will be inserted in sealed envelopes and random allocation will be done by the person not involved in sampling. The shape, weight and appearance of probiotic or ordinary yogurt packages will be same.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.TBZMED.REC.1399.183

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.9
ICD-10 code description
Menopausal and perimenopausal disorder, unspecified

Primary outcomes

1

Description
Depression, anxiety and stress
Timepoint
Before and 6 weeks after the inervention
Method of measurement
DASS-21 (Depression, Anxiety and Stress Scale-21)

2

Description
Sleep quality
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

1

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

Intervention groups

1

Description
Intervention group will consumed 100 grams of yogurt containing probiotics daily for 6 weeks.
Category
Treatment - Other

2

Description
Control group will consumed 100 grams of ordinary yogurt daily for 6 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Tabriz city
Full name of responsible person
Mehrnaz Shafiee
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
9876065489
Phone
+98 41 6754 3456
Email
mehrnaz.sh1610@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 44 9876 5430
Email
mehrnaz.sh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrnaz Shafiee
Position
MSc student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
63619545850
Phone
0098 34 876954376
Email
mehrnaz.sh1610@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 56 7654 3890
Email
mirghafouurvandm@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3452 6493
Email
mirghafourvandm@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of the clinical study will be published as an article.
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
Email: mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document
Up to one week after communication by email
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