The effect of group counceling based on mindfulness on anxiety of infertile women undergoing IVF attended to center of infertility in fatemieh hospital, Hamedan, 2016
(1) Objectives: The study aims at determining the effect of group counceling based on mindfulness on anxiety of infertile women undergoing IVF attended to center of infertility in fatemieh hospital in Hamedan. (2) Design: Randomized clinical trials with pretest-posttest design with a control group. (3) Setting and conduct: 90 infertile women who eligible for inclusion criteria will be recruited to this study. Thease people will randomly divided to two groups. (4) Participants including major eligibility criteria:The mild, more than average and lower than average anxiety (the score of 20 to 53 in accordance with the interpretive criteria on a scale of spielberger anxiety inventory); Age range 25-40 years; High school diploma and more; Resident of Hamedan; Not having antecedent in psychiatric hospital. (5) Intervention: The size of the sample is 90 women with primary infertility. forty five of them, as the experimental group, take part in consultation sessions, and 45 of them, as control group, without any intervention. The experimental group will take part in 8 sessions of consultation classes from the entrance of IVF treatment before the embryo transfer stage. Doing so, the women anxiety will be compared in the groups. The instruments of collecting data are a scale of Spielberger Anxiety Inventory and demographic questionnaire. (6) Primary outcome: Anxiety
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082013405N14
Registration date:2016-09-10, 1395/06/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-10, 1395/06/20
Registrant information
Name
Seyyedeh Zahra Masoumi
Name of organization / entity
Hamedan University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
zahra.masoomi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counceling based on mindfulness on anxiety of infertile women undergoing IVF attended to center of infertility in fatemieh hospital, Hamedan, 2016
Public title
The effect of mindfulness-based group counseling on anxiety in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age range 25-40 years; High school diploma and more; Resident of Hamedan; Not having antecedent in psychiatric hospital; Not having addiction; Not having neurologic disease or other progressive diseases; Not taking psychiatric drugs; The mild, more than average and lower than average anxiety (the score of 20 to 53 in accordance with the interpretive criteria on a scale of spielberger anxiety inventory)
Exclusion criteria: Absence of more than two sessions in counseling sessions in the test group; Naturally get pregnant without assisted reproductive techniques during the course of treatment; Physical or mental illness during the study
Age
From 25 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethic Committee of Hamedan University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan, Iran
City
Hamedan
Postal code
6516645977
Approval date
2016-07-02, 1395/04/12
Ethics committee reference number
IR.UMSHA.REC.1395.182
Health conditions studied
1
Description of health condition studied
Anxiety in infertile women
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and after the intervention (in the process of embryo transfer)
Method of measurement
Spielberger anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Holding eight sessions of mindfulness-based counseling for infertile women included: Automatic guidance; Face with obstacles; Breathing Meditation practice and mindfulness of breathing; Sitting meditation; Acceptance and change and etc; Each session lasts 90 minutes
Category
Behavior
2
Description
Control group: Anxious infertile women with mild; average in low and average in high anxiety (score of 20 to 53 in accordance with the criteria for the interpretation of the questionnaire STAI)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital of Hamedan
Full name of responsible person
Fatemeh Kalhori (MSc student of Consultation in midwifery)
Street address
pasdaran Avenue, Hamedan, Iran
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ethic Committee of Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashirian
Street address
Vice Chancellor of Research and Technology, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan, Iran
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ethic Committee of Hamedan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Masoomi
Position
Assistant professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan, Iran
City
Hamedan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
zahramid2001@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Masoomi
Position
Assistant professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan, Iran
City
Hamedan
Postal code
6516845977
Phone
+98 81383880818
Fax
Email
zahramid2001@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Kalhori
Position
MSc student of counselling in midwifery
Other areas of specialty/work
Street address
School of nursing and midwifery, Hamedan university of medical sciences, Shahid Fahmideh Avenue, Hamedan, Iran
City
Hamedan
Postal code
6517808836
Phone
+98 81 3838 0150
Fax
Email
fkalhori55@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)