Objectives: The aim of the study is to assess the effect of mindfulness psychotherapy on psychological well-being Design: Randomized Controlled Trial Setting and conduct: 60 infertile women who will referred to Infertility Research Center Fatemeh Zahra (SA) Babol will be allocated in four groups based on Solomon trial (n = 15 experiments with pre-test, 15 tests without pre-test, 15 control subjects without pre-test, 15 control with pre-test). Participants: Inclusion criteria are the distance of eight weeks from beginning of using assisted reproduction of microinjection method and no attending in relaxation psychological intervention. Women who use other methods of infertility such as intrauterine insemination will be excluded the study. Interventions: Experimental group will attended in 8 weeks group mindfulness psychotherapy sessions. Control group do not received any interventions. Participants will complete Ryfe Well-being questionnaire and Quality of life before and after the intervention. Main outcome: Psychological well-being and quality of life.
General information
Acronym
Mindfulness and infertility
IRCT registration information
IRCT registration number:IRCT2017021132321N2
Registration date:2017-06-03, 1396/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-03, 1396/03/13
Registrant information
Name
Seyed Mohammad KalantarKoshe
Name of organization / entity
Allameh Tabatabaei University
Country
Iran (Islamic Republic of)
Phone
+98 214480000
Email address
kalantar.counseling@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2015-07-07, 1394/04/16
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness psychotherapy on psychological well-being and quality of life of infertile women
Public title
The effect of mindfulness on psychological well-being and quality of life of infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having ability of reading and writing; The distance of eight weeks from beginning of using assisted reproduction of Microinjection method; without attending relaxation meetings or other psychological interventions; desire to participate in the study and giving informed consent. Exclusion criteria: Infertile women who use other methods of infertility such as intrauterine insemination.
Age
From 17 years old to 44 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
Ethics committee Allameh Tabatabaei university
Street address
Tehran, Olympic square,Olympic village, Allameh Tabatabaei university
City
Tehran city
Postal code
1489684511
Approval date
2014-11-14, 1393/08/23
Ethics committee reference number
1153126
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Psychological well-being
Timepoint
Before and after completion of the intervention
Method of measurement
Psychological well-being questionnaire Ryff
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and after intervention
Method of measurement
Quality of life questionnaire short form of 26 questions
Intervention groups
1
Description
Intervention group:
The meetings based Kabat-Zinn mindfulness-based psychotherapyon 8 session 120-minute once a week, in two groups of 15 people will be held. The subject with participating in sessions based on Kabat-Zinn mindfulness-based psychotherapy will be able through practicing mindfulness relieved from automatic negative that are released during disturbing events such as infertility. And in one of the intervention groups before and after the intervention in both groups completed the questionnaire.
Category
Behavior
2
Description
Control group: In one of the control groups before the intervention and control groups completed questionnaires immediately after the intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and Reproductive Health Research Center Fatemeh Zahra (SA) Babol
Full name of responsible person
Dr. Mahbobe Faramarzi
Street address
Street martyr Salehi, after Mohammad Hassan Khan Bridge, Tork mahale village
City
Babol city
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Allameh Tabatabaei University
Full name of responsible person
Seyed Mohammad Kalantar Koshe
Street address
Olympic Square, Olympic Village, Village and Hemmat Blvd.
City
Tehran
Grant name
8830000
Grant code / Reference number
2324922
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabatabaei University
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
Allameh Tabatabaei University
Full name of responsible person
Tahere Rahmani Fard
Position
Master of science
Other areas of specialty/work
Street address
Olympic Square, Olympic village, Village and Hemmat Blvd.
City
Tehran city
Postal code
4719756893
Phone
+98 11 3227 0430
Fax
+98 11 3232 2932
Email
tahere_aligholizade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allameh Tabatabaei University
Full name of responsible person
Seyed Mohammad Kalantar Koshe
Position
PhD of consulting
Other areas of specialty/work
Street address
Olympic square, Olympic vllage, Village and Hemmat Blvd
City
Tehran city
Postal code
۱۴۸۹۶۸۴۵۱۱
Phone
+98 21 4473 7510
Fax
Email
kalantar. counseling@atu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Allameh Tabatabaei University
Full name of responsible person
Tahere Rahmani Fard
Position
Master of science
Other areas of specialty/work
Street address
Olympic square, Olympic vllage, Village and Hemmat Blvd
City
Tehran city
Postal code
4719756893
Phone
+98 11 3232 2932
Fax
+98 11 3232 2932
Email
tahere_aligholizade@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)