Objective for this research is to compare the effectiveness of meditation meta-cognitive therapy in reducing anxiety in pregnant women in the last trimester of pregnancy.
Design
tow experimental group, target sampling, peer based on age, job and education, not blinded
Settings and conduct
pregnancy woman took part in individually meta-cognitive therapy (MCT) and meditation sessions in a privet counseling clinic. The score of anxiety in the pre-test anxiety in pregnancy, during therapy sessions( second, forth, sixth and eighth), end of therapy sessions and follow-up phase (40 days after the end of therapy sessions) were assessed.
Participants/Inclusion and exclusion criteria
Inclusion: satisfaction and high pregnancy anxiety score in pregnant women in the last trimester.
exclusion: serious physical disease and mental disorder
Intervention groups
The first group of intervention group took part in individually meta-cognitive therapy (MCT) in 8 sessions and second group of intervention group took part in individually meditation in 7 sessions.
Main outcome variables
anxiety in pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180610040042N1
Registration date:2018-06-27, 1397/04/06
Registration timing:retrospective
Last update:2018-06-27, 1397/04/06
Update count:0
Registration date
2018-06-27, 1397/04/06
Registrant information
Name
Azra Zebardast
Name of organization / entity
University of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 13 3358 5097
Email address
zebardast@guilan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
2015-03-21, 1394/01/01
Actual recruitment end date
2016-03-19, 1394/12/29
Trial completion date
empty
Scientific title
Effectiveness of Meditation as a Meta- Cognitive Therapy in Reducing Anxiety in Pregnant Women in the Last Trimester of Pregnancy
Public title
Effectiveness of Meditation as a Meta- Cognitive Therapy in Reducing Anxiety in Pregnant Women in the Last Trimester of Pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant Women in the Last Trimester of Pregnancy
Pregnancy anixety
Minimum Education Is Graduated of High School
Voluntarily and Satisfaction
Exclusion criteria:
Mental Disorders other than pregnancy anxiety
Serious Physical Illness
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
8
Actual sample size reached:
8
Randomization (investigator's opinion)
Not 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 of Islamic Azad University, Rasht Branch
Street address
Islamic Azad University, Rasht Branch, Darvazeh Lakan Street, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2013-03-13, 1391/12/23
Ethics committee reference number
17-335/6114
Health conditions studied
1
Description of health condition studied
Pregnancy Anixty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of Pregnancy Anxiety in pregnancy anxiety scale (PRAQ)-Van den Bergh
Timepoint
Participants anxiety in pregnancy measured in the pre- test, during therapy sessions ( for metacognition therapy group: end of second, forth, sixth and eighth therapy session and for mediation therapy group: end of second, forth and sixth session) and follow-up phase (40 days after the end of therapy sessions).
Method of measurement
pregnancy anxiety scale (PRAQ)-Van den Bergh
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group took part in individually meditation in 7 sessions and every session was held for 45 minutes. first session was about practical relaxation, second session was about Diaphragmatic breathing, third session was about reviewing home work, forth session was about controlling of thought about past and future, fifth session was about ignoring of sadness, sixth session was about monitoring of thought, sensation and emotion and seventh session was about reviewing of all learned skills.
Category
Treatment - Other
2
Description
Intervention group: second group took part in individually meta-cognitive therapy (MCT) in 8 sessions and every session was held for 45 minutes. MCT was so that: 1- case conceptualization; 2- preparation for therapy; 3- Induction of induction of meta- cognition; 4- challenging with meta cognitive believes about Uncontrollably; 5- challenging with meta cognitive believes about worry; 6- challenging with meta cognitive positive believes about worry; 7- Reinforcing of new processing about worry; 8- to prevent of relapse.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Private Clinic Obstetricians
Full name of responsible person
Roya Fraji
Street address
facing the Revolutionary mosque, Hajiabad Street ,Rasht, Guilan.
City
Rasht
Province
Guilan
Postal code
41367119779
Phone
+98 13 3322 7020
Email
royafaraji@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Seidavy
Street address
Deputy of research and technology, Islamic Azad university, Berench of Rasht, Lkan Street, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3242 4079
Email
alirezaseidavi@iaurasht.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
University of Guilan
Full name of responsible person
Azra Zebardast
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology, Faculty of Literature and Humanity sciences, University of Guilan, Rasht, Guilan.
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3358 5097
Fax
Email
zebardast@guilan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Azra Zebardast
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology, Faculty of Literature and Humanity sciences, University of Guilan, Rasht, Guilan.
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3358 5097
Fax
Email
zebardast@guilan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Azra Zebardast
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology, Faculty of Literature and Humanity sciences, University of Guilan, Rasht, Guilan.
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3358 5097
Fax
Email
zebardast@guilan.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available