1. Home
  2. Approved trials
  3. » فارسی

The effectiveness of Mindfulness- Based Cognitive Therapy on Worry ,State anexity and Ambiguity Tolerance in infertil women under IVF

Protocol summary

Study aim
1-Determining the effectiveness of mindfulness-based cognitive therapy on the 2-Determining the effectiveness of mindfulness-based cognitive therapy on the state anexity of infertile women undergoing IVF treatment 3-Determining the effectiveness of mindfulness-based cognitive therapy on the Ameiguity Tolerance of infertile women undergoing IVF treatment
Design
The sample size was determined based on previous similar studies using Treatment Center in Mashhad were selected by targeted sampling method and randomly tested and controlled in two groups of 20 people. .
Settings and conduct
Center in Mashhad. protocol, the control group does not receive any intervention and training. Before and after the intervention, the anxiety, state anxiety and unbearable anxiety questionnaires for both the experimental and control groups are completed. Will be
Participants/Inclusion and exclusion criteria
- Entry requirements: having a history of infertility, IVF diagnostic therapy Failure to enter: Having a specific underlying disease (hypothyroidism, diabetes, heart disease, high blood pressure, etc.) Non-IVF (and IUI) treatment methods
Intervention groups
8 2-hour training sessions a week receive a mindfulness training protocol, the control group does not receive any intervention or training. Before and after the intervention, the anxiety, state anxiety and unbearable anxiety questionnaires for both the experimental and control groups are completed. Will be
Main outcome variables
In this study,The Effect of mindfulness-based cognitive therapy on Worry, State anxiety, and Ambiguity Tolerance in infertile women undergoing IVF treatment is examinad.

General information

Reason for update
Acronym
MBCT
IRCT registration information
IRCT registration number: IRCT20200518047499N1
Registration date: 2020-05-21, 1399/03/01
Registration timing: retrospective

Last update: 2020-05-21, 1399/03/01
Update count: 0
Registration date
2020-05-21, 1399/03/01
Registrant information
Name
Zohreh Nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5252 6992
Email address
z.nasiri@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-08-23, 1398/06/01
Trial completion date
2019-10-23, 1398/08/01
Scientific title
The effectiveness of Mindfulness- Based Cognitive Therapy on Worry ,State anexity and Ambiguity Tolerance in infertil women under IVF
Public title
Mindfulness On Worry, State anexity ,Ambiguity Tolerance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women under IVF Treatment Having physical and mental health Higher education than guidance Awareness and willingness of people to attend meetings
Exclusion criteria:
Infertility treatment other than ivf Simultaneous infection with the underlying disease Being illiterate
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Actual sample size reached: 35
Randomization (investigator's opinion)
Randomized
Randomization description
In a simple random way, people's names were written on sheets of paper and the sheets were placed in a container.The names extracted from the container were then substituted one by one and completely randomly in the control and intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the intervention group received training, and after completing the training and post-test, both groups,For the control group, training sessions were held briefly.While both groups were unaware of the title of the group they were in
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hormozgan University of Medical Sciences Ethics Committee
Street address
Enghelab Square, Shahid Chamran Boulevard
City
bandare abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
IR.HUMS.REC.1399.090

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Worry score in Pennsylvania questionnaire, state anxiety score in Spielberger questionnaire, Ambiguity Tolerance score in Freestone unambiguity tolerance
Timepoint
Measure before starting the intervention. After the intervention, 3 months after the intervention to follow up
Method of measurement
Complete the relevant questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Awareness training protocol was taught in groups for 8 sessions of 2 hours a week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad Infertility Center in Mashhad
Full name of responsible person
Dr. Nayreh Khadem Ghaibi
Street address
razi street
City
MASHHAD
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Fax
+98 51 3853 4021
Email
ivfcenter@yahoo.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Kish International Branch
Full name of responsible person
Dr. Alireza Rousta
Street address
sanaee street
City
Kish Island
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Fax
+98 76 4442 3957
Email
Researchkish3@gmail.com
Web page address
https://iaukish.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, Kish International Branch
Proportion provided by this source
50
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
Islamic Azad University, Kish International Branch
Full name of responsible person
hassan ahadi
Position
full Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
sanaee street
City
Kish Island
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Fax
+98 76 4442 3957
Email
hahadi5@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Kish International Branch
Full name of responsible person
hassan ahadi
Position
full Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
sanaee street
City
kish island
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Email
hahadi5@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Kish International Branch
Full name of responsible person
zohreh nasiri
Position
University student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
sanaee street
City
Kish Island
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Fax
+98 76 4442 3957
Email
znasiri1360@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Failure to issue permits even anonymously to participants
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...