This study has been conducted to investigate the effect of mindfulness-based training on health related quality of life and female sexual distress 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 or surgical menopause, between at least the first and at last the fifth years after the normal menstrual cycles’ stop, being married,Without any physical disability to do the techniques and This technique has not been used in the past six months. Exclusion criteria include: a self-report of concurrent or history of psychological disorders as well as taking antipsychotic medications, taking Hormone Replacement Therapy (HRT) or vagial estrogen, Fill out the questionnaire incompletely, 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 and Unwillingness to participate in the study any more.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:IRCT2015121623344N2
Registration date:2016-05-07, 1395/02/18
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-05-07, 1395/02/18
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
2015-12-31, 1394/10/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based training on health related quality of life and female sexual distress in postmenopausal women
Public title
The effect of mindfulness-based training on health related quality of life and female sexual distress in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Natural or surgical menopause; 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; Being married; 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;Occurrence of misadventure in the past six months; Taking Hormone Replacement Therapy (HRT) or using vaginal estrogen in the past six months; Fill out the questionnaire incompletely; Self-report of dependence on nicotine, alcohol, opioids and other psychotropic drugs; Absences of more than two sessions; 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
Golestan Blvd
City
Ahvaz
Postal code
15794-61357
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.AJUMS.REC.1394. 564
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
Health related quality of life
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Health related quality of life(SF36)
2
Description
Female sexual distress
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Female sexual distress scale(FSDS)
Secondary outcomes
1
Description
Physical functioning(PF)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Questions 3 to 12 of SF36
2
Description
Role physical(RF)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Questions 13 to 16 of SF36
3
Description
Role emotional(RE)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Questions 17 to 19 of SF36
4
Description
Vitaity(VT)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 23, 27, 29 and 31 of SF36
5
Description
Mental health(MH)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 24, 25, 26, 28 and 30 of SF36
6
Description
Social functioning
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 20 and 32 of SF36
7
Description
Bodily pain(BP)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 21 and 22 of SF36
8
Description
General health(GH)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 1, 33 and 36 of SF36
9
Description
The Physical Component of Summary(PCS)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
PF+RF+BP+GH dimensions of SF36 Questionnaire
10
Description
The Mental Component Summary(MCS)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
SF+RE+MH+VT dimentions of SF36 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
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.comYazdani.m@ajums.ac.ir
Web page address
-
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
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)