Protocol summary

Study aim
Determining the effectiveness of Mindfulness-Based Stress Reduction on depression, anxiety, and stress of women with the early loss of pregnancy
Design
A clinical trial with two intervention and control groups, without blinding, randomized based on a random allocation table, the intervention was conducted during 8 sessions on 53 people in the intervention group.
Settings and conduct
The study was conducted in Zainabiyah Hospital, Shiraz. After identifying the women with the termination of the first trimester of pregnancy, if they met the criteria for participation in the study, the purpose of the research was explained to them if they wished, and they signed written informed consent. People were randomly placed in two intervention and control groups according to the allocation table. Both groups completed the pre-test, and then eight mindfulness sessions were held for the intervention group for eight weeks; after the intervention, both groups completed the post-test.
Participants/Inclusion and exclusion criteria
Entry conditions: bleeding, gestational age under 20 weeks Conditions of non-entry: unintended pregnancy, history of mental illness, use of neuropsychiatric drugs, recent great stress
Intervention groups
For the intervention group, 8 sessions of 2 to 2.5 hours of mindfulness group counseling were conducted in 8 weeks. The control group received usual post-pregnancy care
Main outcome variables
Reduce stress, reduce anxiety, reduce depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151103024866N17
Registration date: 2022-09-24, 1401/07/02
Registration timing: retrospective

Last update: 2022-09-24, 1401/07/02
Update count: 0
Registration date
2022-09-24, 1401/07/02
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
2020-07-31, 1399/05/10
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
2020-07-31, 1399/05/10
Actual recruitment end date
2021-01-09, 1399/10/20
Trial completion date
2021-01-09, 1399/10/20
Scientific title
Effectiveness of Mindfulness-Based Stress Reduction on depression, anxiety, and stress of women with the early loss of pregnancy
Public title
The effect of mindfulness on psychological problems after abortion
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All women with bleeding in the first trimester of pregnancy that led to termination of pregnancy
Exclusion criteria:
The current pregnancy was unintended Have a history of mental illness She is currently taking psychiatric drugs He is currently undergoing psychological counseling She has suffered a major stressful event from two months before the study until now
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
Actual sample size reached: 106
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random Allocation table Randomization has been done by the block method. We considered the intervention group as "A" and the control group as "B", and then 27 blocks of 4 combinations of "A, B" were randomly selected using R version 3.2.1 statistical software. A sequence of letters A, B was produced, and each person who referred to the Zeinabieh hospital was placed in the intervention or control group based on the sequence produced
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
Razi Nursing and Midwifery Faculty., Kerman University of Medical Sciences Campus., Haft Bagh Alavi Highway
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
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

2

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

3

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Stress score from the Depression- Anxiety- Stress Scale
Timepoint
Before intervention and after completion of counseling sessions
Method of measurement
Depression- Anxiety- Stress Scale

2

Description
Anxiety score from the Depression- Anxiety- Stress Scale
Timepoint
Before intervention and after completion of counseling sessions
Method of measurement
Depression- Anxiety- Stress Scale

3

Description
Depression score from the Depression- Anxiety- Stress Scale
Timepoint
Before intervention and after completion of counseling sessions
Method of measurement
Depression- Anxiety- Stress Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, 8 sessions of 2 to 2.5 hours of mindfulness group counseling were conducted in 8 weeks.
Category
Behavior

2

Description
Control group: Routine post-abortion care was given.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Zeinabieh hospital
Full name of responsible person
Masumeh Nasrollahi
Street address
Zeinabieh hospital., Defae Mogadas squar
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Deputy of research and technology., Somayeh Crossroads
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
vcr@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
Katayoun Alidousti
Position
Instructor of the midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor of the midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor of midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com

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
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
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