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Investigating The Effectiveness of Mindfulness-Based Stress Reduction(MBSR) on the Rate of Anxiety, Depression and stress in women with first trimester leads to termination of pregnancy referred to Hazrat Zeynab Hospital in Shiraz in 2019بررسی اثر مشاوره ذهن آ

Protocol summary

Study aim
1- Determining and comparing the mean score of anxiety, stress and depression of women referred to hemorrhage leading to termination of pregnancy in intervention and control group before and after counseling in Hazrat Zeinab Hospital in Shiraz in 98
Design
A randomized controlled clinical trial was conducted with randomized groups that were divided into control and intervention groups using a random allocation table, each containing 57 individuals.
Settings and conduct
first trimester hemorrhage referred to Hazrat Zeinab Hospital in Shiraz Using a random allocation table, they are divided into two groups of control and intervention, with 8 sessions of mindfulness group counseling that will take place 2 to 2.5 hours per week, and even if they are discharged, they will be invited to attend the consultation by phone number. It will be done two weeks after the last test post session of intervention group and post test control group will be analyzed.
Participants/Inclusion and exclusion criteria
Women with first trimester hemorrhage who have lost their pregnancy, tendency to participate in research, no history of known mental illness, no use of psychological medication, no more than two months before the start of the study lack of an event that causes anxiety, depression And stress, no hearing-impaired speech and no addiction
Intervention groups
Eight sessions of mindfulness-based cognitive therapy on women with first trimester hemorrhage lead to termination of pregnancy in the intervention group to reduce or relieve stress, anxiety, and depression. Assume a control group with the same characteristics that no intervention is performed on them.
Main outcome variables
Stress, anxiety, depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190627044036N1
Registration date: 2019-12-11, 1398/09/20
Registration timing: retrospective

Last update: 2019-12-11, 1398/09/20
Update count: 0
Registration date
2019-12-11, 1398/09/20
Registrant information
Name
maasumeh nasrollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3738 4729
Email address
azitamail@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effectiveness of Mindfulness-Based Stress Reduction(MBSR) on the Rate of Anxiety, Depression and stress in women with first trimester leads to termination of pregnancy referred to Hazrat Zeynab Hospital in Shiraz in 2019بررسی اثر مشاوره ذهن آ
Public title
The effect of mindfulness counseling on stress, anxiety and depression in pregnant women with first trimester bleeding who lose their pregnancy.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with first trimester hemorrhage who have lost their pregnancy desire to participate in research no known history of mental illness no use of psychological medication than two months before the start of the study no accident causing anxiety, Depression and stress hearing-impaired speech non-addiction
Exclusion criteria:
Pregnancy unwillingness to continue to cooperate with research An unfortunate event that causes anxiety, stress or depression Refusal to attend more than one meeting
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random allocation table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Experimental parameters of hemoglobin and beta-titers and quality of life are measured alongside the study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences Student Ethics Committee
Street address
Kerman University of Medical Sciences, Kerman University of Medical Sciences, Kerman, Iran Post Code 7616913555
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.KMU.REC.1398.217

Health conditions studied

1

Description of health condition studied
Stress, anxiety, depression
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety score in dass 21
Timepoint
Two weeks after MBSR Consulting
Method of measurement
Dass 21 questionnaire

2

Description
Depression score on dass 21
Timepoint
Two weeks after MBSR Consulting
Method of measurement
Dass 21 questionnaire

3

Description
Stress score in dass 21
Timepoint
Two weeks after MBSR Consulting
Method of measurement
Dass 21 questionnaire

Secondary outcomes

1

Description
Does not exist
Timepoint
Does not exist
Method of measurement
Does not exist

Intervention groups

1

Description
Intervention group 1: Three patients with abortion under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire followed by mindfulness-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And the same questionnaire as the test post is completed two weeks after the sessions the same questionnaire as the test post.
Category
Prevention

2

Description
Intervention group 2: Three patients with abortion under 14 weeks of gestation after filling out the pre-test DASS 21 psychiatric questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And the same questionnaire as the test post is completed two weeks after the sessions.
Category
Prevention

3

Description
Intervention group 3: Three patients with H.mole under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire and then mindfulness-based counseling during 8 sessions of 2 to 2 and a half hours. And the same questionnaire as the test post is completed two weeks after the sessions.
Category
Prevention

4

Description
Intervention group 4: Three patients with abortion under 14 weeks of gestation after filling out the pre-test DASS 21 psychiatric questionnaire and then mindfulness-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And the same questionnaire as the test post is completed two weeks after the sessions.
Category
Prevention

5

Description
Intervention group 5: Three patients with ectopic pregnancy and under 14 weeks of gestation after filling out the DASS 21 psychiatric questionnaire completed as a pre-test followed by (same) mindfulness counseling during 8 sessions 2 It takes up to 2 and a half hours, and the same questionnaire as the test post is done again two weeks after the sessions.
Category
Prevention

6

Description
Intervention group 6: Three patients with abortion under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire then administered (identical) mindfulness counseling during 8 sessions of 2 to 2 and a half hours. And two weeks after the end of the sessions, the same questionnaire as the test post is performed again.
Category
Prevention

7

Description
Intervention group 7: Three patients with abortion under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And two weeks after the end of the sessions, the same questionnaire as the test post is performed again.
Category
Prevention

8

Description
Intervention group 8: Three patients with H.mole under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And two weeks after the end of the sessions, the same questionnaire as the test post is performed again.
Category
Prevention

9

Description
Intervention group 9: Three patients with abortion under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And two weeks after the end of the sessions, the same questionnaire as the test post is performed again.
Category
Prevention

10

Description
Intervention group 10": Three patients with abortion under 14 weeks of gestation after molar pregnancy, after filling out the DASS 21 psychiatric questionnaire completed as a pre-test, then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half It is done hourly and again two weeks after the end of the sessions, the same questionnaire as the test post.
Category
Prevention

11

Description
Intervention group 11: Three patients with abortion under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire, then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And two weeks after the end of the sessions, the same questionnaire as the test post is performed again.
Category
Prevention

12

Description
Intervention group 12 : Three patients with lost ectopic pregnancy and under 14 weeks of gestation after filling in pre-test DASS 21 psychological questionnaire then mindfulness-based counseling during 8 sessions 2 It takes up to 2 and a half hours, and the same questionnaire as the test post is done again two weeks after the sessions.
Category
Prevention

13

Description
Intervention group 13: Three patients with abortion under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And two weeks after the end of the sessions, the same questionnaire as the test post is performed again.
Category
Prevention

14

Description
Intervention group 14: Three patients with abortion under 14 weeks of gestation and mole pregnancy after filling out a pre-test DASS 21 psychological questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half It is done hourly and again two weeks after the end of the sessions, the same questionnaire as the test post.
Category
Prevention

15

Description
Intervention group 15": Three patients with mole under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And two weeks after the end of the sessions, the same questionnaire as the test post is performed again.
Category
Prevention

16

Description
Intervention group 16: Three patients with missing ectopic pregnancy and under 14 weeks of gestation after filling in the DASS 21 psychiatric questionnaire completed as a pre-test then mindfulness-based counseling during 8 sessions 2 It takes up to 2 and a half hours, and the same questionnaire as the test post is done again two weeks after the sessions.
Category
Prevention

17

Description
Intervention group 17: Three patients with abortion under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And the same questionnaire as the test post is completed two weeks after the sessions.
Category
Prevention

18

Description
Intervention group: 18: Three patients with abortion under 14 weeks of gestation after filling out a pre-test DASS 21 psychiatric questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And the same questionnaire as the test post is completed two weeks after the sessions.
Category
Prevention

19

Description
Intervention group 19: Three patients with H. mole under 14 weeks of gestation after filling out the pre-test DASS 21 psychiatric questionnaire then mind-based (identical) counseling during 8 sessions of 2 to 2 and a half hours. And the same questionnaire as the test post is completed two weeks after the sessions
Category
Prevention

20

Description
Control group: In the control group, the Dass 21 questionnaire is first filled out and after one and a half months the same questionnaire is checked again, meaning that without any grouping and intervention only the questionnaire is checked.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Zeinab Hospital
Full name of responsible person
Alidousti Katayun
Street address
Hazrat Zeinab Hospital , Khatun square , Sibuyeh Blvd;
City
Shiraz
Province
Fars
Postal code
7153811311
Phone
+98 71 3726 6816
Fax
+98 71 3726 5252
Email
azitamail@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mirzaei Firouzeh
Street address
Kerman University of Medical Sciences , Seven Gardens of Alavi
City
Kerman
Province
Kerman
Postal code
76169135555
Phone
+98 34 3132 5449
Fax
+98 34 3132 5218
Email
nmf@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
Alidousti Katayun
Position
Group Manager and Supervisor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Razi School of Midwifery ، Seven Gardens of Alavi
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
kalidoosti@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alidoosti Katayoun
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Seven Alavi Gardens
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5218
Email
azitamail@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrollahi Masoumeh
Position
Student Of Midwifery And Medical Student Of Shiraz
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No 378 ، Ally 6 ، Twenty Meters Saheb Az Zaman
City
Shiraz
Province
Fars
Postal code
7165854576
Phone
+98 71 3738 4729
Fax
+98 71 3726 5252
Email
azitamail@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Since one of the most effective factors in improving the mental status of women during pregnancy and afterwards is social support and mindfulness counseling is a newer and more practical way to get a room to continue this program at Hazrat Zeinab Hospital To be considered.ا
When the data will become available and for how long
Early in the year 2020
To whom data/document is available
assistance Health Shiraz and Kerman university of medical sciences and head of the hospital of hazrat zainab
Under which criteria data/document could be used
If the research is effective and has a positive impact on mothers' mental health
From where data/document is obtainable
Kerman University of Medical Sciences or Shiraz University of Medical Sciences
What processes are involved for a request to access data/document
Kerman University of Medical Sciences - Razi School of Midwifery - Vice Chancellor for Research - Research Thesis in 2019
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