Determination Effect of Mindfulness-Based Stress Reduction on stress, anxiety and depression of unintended pregnancy in women referred to health care centers in Sirjan, 2017
Design
Clinical trial with control and intervention group, simple randomization, 30 patients under consultation and 30 controls, one blind.
Settings and conduct
Health care Centers of Sirjan. Individuals fill out the anxiety, stress and depression dass questionnaire, then they are randomly assigned to two groups of control and intercourse. The intervention group is counseled and then, all individuals in the intervention and control group fill out again questionnaire.
Participants/Inclusion and exclusion criteria
intrance: Having a Wife. Age between15-49 Years. Pregnancy Age 10-32 Weeks. Absence of Neurological and Mental Disorder and Substance Abuse. Readiness and Satisfaction to Participate in the Research.
exist: Having at Least One Item of Stress Score 0-7 or Anxiety 0-3 or Depression 0-4. Absence More Than the two Sessions. Not Doing Practices. Unwillingness to Continue the Sessions. Indication Major Stresses and Acute Accidents. Getting Acute Psychotic Illnesses, incidence of pregnancy complications such as bleeding, high blood pressure, preterm delivery and intrauterine death.
Intervention groups
Mindfulness-Based Stress Reduction on stress, anxiety and depression of unintended pregnancy.
Main outcome variables
Condition of Anxiety, Stress and Depression of Unintended Pregnancy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151103024866N14
Registration date:2019-03-16, 1397/12/25
Registration timing:registered_while_recruiting
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Katayoun Alidousti
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
alidoosti@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Mindfulness-Based Stress Reduction on stress, anxiety and depression of unintended pregnancy in women referred to health care centers.
Public title
Effect of Mindfulness-Based Stress Reduction on stress, anxiety and depression of unintended pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a Wife.
Age between15-49 Years.
Pregnancy Age 10-32 Weeks.
Absence of Neurological and Mental Disorder and Substance Abuse.
Readiness and Satisfaction to Participate in the Research.
Exclusion criteria:
Having at Least One Item of Stress Score 0-7 or Anxiety 0-3 or Depression 0-4.
Absence More Than the two Sessions.
Not Doing Practices.
Unwillingness to Continue the Sessions.
Indication Major Stresses and Acute Accidents.
Getting Acute Psychotic Illnesses.
Age
From 15 years old to 49 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
After selecting the sample from the available sampling method, we divide them into a simple randomized draw metod into two groups of intervention and control.
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 Kerman University of Medical Sciences
Street address
Nursing and Midwifery Collage
City
Kerman
Province
Kerman
Postal code
7419476196
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.KMU.REC.1397.487
Health conditions studied
1
Description of health condition studied
mental health in unintended pregnancy
ICD-10 code
z64.0
ICD-10 code description
problems related to unwanted pregnancy
Primary outcomes
1
Description
anxiety, stress, depression
Timepoint
At the beginning of the study and one week after the completion of the intervention
Method of measurement
dass-21پرسشنامه
Secondary outcomes
empty
Intervention groups
1
Description
Control group: People who do not get any consultation
Category
N/A
2
Description
Intervention group: 30 People are available for consultation on mindfulness based-stress reduction, which will be held in 8 sessions of 2 hours (weekly one session).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers
Full name of responsible person
Fatemeh Khajoie Nejad
Street address
Kerman Nursing & Midwifery
City
Sirjan
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
Alidoosti@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Pardakhti
Street address
Jahad street
City
kerman
Province
Kerman
Postal code
7419476196
Phone
+98 34 3132 5219
Email
pardakhti@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
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
Kerman University of Medical Sciences
Full name of responsible person
Kobra Alidoosti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Collage
City
Kerman
Province
Kerman
Postal code
7619613555
Phone
+98 34 3132 5219
Email
Alidoosti@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kobra Alidoosti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Collage
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
Alidoosti@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fateme Khajoie Nejad
Position
Master Degree Student in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan22, Boulevar Golestan, Sirjan
City
Sirjan
Province
Kerman
Postal code
7816857999
Phone
+98 34 4230 6483
Email
khajoei.fateme@gmail.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
No more information
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