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The effect of mindfulness training on quality of life in postmenopause women

Protocol summary

Summary
This study has been conducted to investigate the effect of mindfulness training on quality of life in postmenopausal women. Menopause women in Ahvaz are the population of the study in this Randomized Control Trial. The samples of the study are the women with eligibility criteria and willingness to participate in this study. Inclusion criteria include: natural menopause, being married, between at least the first and at last the fifth years after the normal menstrual cycles’ stop, low and moderate quality of life and being fluent in Persian. Exclusion criteria include: a self-report of concurrent or history of psychological disorders as well as taking antipsychotic medications, taking Hormone Replacement Therapy (HRT), occurrence of misadventure in the past six months,self-report of dependence on nicotine, alcohol, opioids and other psychotropic drugs and absences of more than two sessions. This RCT is recruiting 60 women (30 participants in each of the control and the intervention groups) from east and west health centers of Ahvaz. For the intervention group(5 groups comprising 6 participants), mindfulness training will be performed just once a week, in 120 minutes and during 8 sessions, according to MBSR protocol by Jon Kabat-Zinn in 2014. For the control group, three months after the intervention and at the end of three stages of evaluation, mindfulness training will be performed in 2 sessions, because of ethical considerations. All participants will complete Menopause Specific Quality of Life questionnaire before the intervention, immediately after the intervention and three months after the intervention completion.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015072523344N1
Registration date: 2015-10-27, 1394/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-27, 1394/08/05
Registrant information
Name
Masoomeh Yazdani Aliabadi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 911 157 1204
Email address
yazdani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Jundishapur University of Medical Science
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness training on quality of life in postmenopause women
Public title
The effect of mindfulness training on quality of life in postmenopause women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Natural menopause(not because of drug consumption or surgery); Women between 47 to 62 years of age; Between at least the first and at last the fifth years after the normal absence of menstrual cycles; Low and moderate quality of life; Being married; Being fluent in Persian; Without any physical disability to do the techniques; This technique has not been used in the past six months. Exclusion Criteria: A self-report of concurrent or history of psychological disorders; Taking antipsychotic medications; Taking Hormone Replacement Therapy (HRT) or using vaginal estrogen in the past six months; Self-report of dependence on nicotine, alcohol, opioids and other psychotropic drugs; Occurrence of misadventure in the past six months; Absences of more than two sessions; Fill out the questionnaire incompletely; Unwillingness to participate in the study any more.
Age
From 47 years old to 62 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Science
Street address
Khuzestan, Ahvaz, Golestan Blvd, Jundishapur University of Medical Science, Vice Chancellor for Reaserch
City
Ahvaz
Postal code
-
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.AJUMS.REC.1394. 192

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause

Primary outcomes

1

Description
Menopause Specific Quality of Life
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Menopause Specific Quality of Life Questionnaire

Secondary outcomes

1

Description
Vasamotor domain
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Menopause Specific Quality of Life Questionnaire

2

Description
Psycho-social domain
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Menopause Specific Quality of Life Questionnaire

3

Description
Physical domain
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Menopause Specific Quality of Life Questionnaire

4

Description
Sexual domain
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Menopause Specific Quality of Life Questionnaire

Intervention groups

1

Description
Intervention group: According to MBSR protocol (Jon Kabat-Zinn, 2014) mindfulness training will be performed just once a week, in 120 minutes and during 8 sessions for each of 5 groups.
Category
Behavior

2

Description
Control group: Because of ethical considerations, mindfulness training will be performed in 2 sessions, three months after the intervention and at the end of three stages of evaluation.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
East Health Centers of Ahvaz
Full name of responsible person
Masoomeh Yazdani Aliabadi
Street address
Golestan Blvd, Golestane Enghelab Dormitory of University of Medical Science
City
Ahvaz

2

Recruitment center
Name of recruitment center
West Health Centers of Ahvaz
Full name of responsible person
Masoomeh Yazdani Aliabadi
Street address
Golestan Blvd, Golestane Enghelab Dormitory of University of Medical Science
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Nader Saki
Street address
Golestan Blvd, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Mojgan Javadnoori
Position
PhD of Reproductive Health, Assistant Professor
Other areas of specialty/work
Street address
Golestan Blvd, Golestane Enghelab Dormitory of Jundishpur University of Medical Science
City
Ahvaz
Postal code
-
Phone
00
Fax
Email
mozhganjavadnoori@yahoo.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Masoomeh Yazdani Aliabadi
Position
MSc. Student of Counseling in Midwifery
Other areas of specialty/work
Street address
Golestan Blvd, Golestane Enghelab Dormitory of Jundishapur University of Medical Science
City
Ahvaz
Postal code
-
Phone
00
Fax
-
Email
Yazdani_mw89@yahoo.com Yazdani.m@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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