Comparison of the quality of life of infertile women in two groups without receiving education and with presenting education based on mindfulness-based stress reduction program
The efficacy of education based on mindfulness-based stress reduction program on the quality of life of infertile women
Design
In this research, 36 infertile women refer to infertility center of Ahvaz Imam Khomeini hospital will be chosen. Cases will be allocated to two equal groups of intervention and control according to block randomization method.
Settings and conduct
This interventional study will be conducted on infertility center of of Ahvaz Imam Khomeini hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ability to participate in treatment sessions; primary infertility more than 3 years; being able to read and write; having poor quality of life score (50 or less) in pretest.
Exclusion criteria: having physical inability for doing treatment techniques; having history of doing treatment techniques during 6 months ago; having substance abuse and drug and alcohol addiction; use of anti-psychotic drugs.
Intervention groups
Cases will be allocated to two equal groups of intervention and control according to block randomization method. Then for group education, intervention group will be divided to 3 groups with 6 cases in each group and group education will be provided based on mindfulness-based stress reduction program by researcher in 8 sessions with 2 hours duration weekly. In control group, cases will not receive any specific education. However, education will be presented to all cases in control group at the end of the study.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180307038993N1
Registration date:2018-05-04, 1397/02/14
Registration timing:prospective
Last update:2018-05-04, 1397/02/14
Update count:0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Masoumeh Sadat Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 7297
Email address
hosseini.m.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the quality of life of infertile women in two groups without receiving education and with presenting education based on mindfulness-based stress reduction program
Public title
The efficacy of education based on mindfulness-based stress reduction program on the quality of life of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to participate in treatment sessions
Primary infertility more than 3 years
Being able to read and write
Having poor quality of life score (50 or less) in pretest
Exclusion criteria:
Having physical inability for doing treatment techniques
Having history of doing treatment techniques during 6 months ago
Having substance abuse and drug and alcohol addiction
Use of anti-psychotic drugs
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Cases will be allocated to two equal groups of intervention and control according to block randomization method.
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
IR.AJUMS.REC.1396.907
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Quality of life
Timepoint
Before, immediately after and one month after intervention
Method of measurement
Short form of quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For group education, intervention group will be divided to 3 groups with 6 cases in each group and education will be provided by researcher based on mindfulness-based stress reduction program in 8 sessions with 2 hours duration weekly.
Category
Lifestyle
2
Description
Control group: In control group, cases will not receive specific education. However, education will be presented to all cases in control group at the end of the study.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center of Ahvaz Imam Khomeini hospital