Protocol summary

Study aim
Determining the effect of mindfulness counseling on anxiety in pregnant women with a history of preterm delivery
Design
Clinical trial with control group, with parallel groups and the volume of each group of 6 people, randomized by blocking method
Settings and conduct
Samples will be selected from pregnant women referring to health centers in Ahvaz by available sampling method. Those who score on the Spielberger Anxiety Inventory are selected. Samples are randomly divided into sixteen blocks of six and are assigned to intervention and control groups. In the intervention program, individuals are divided into groups of five or less.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with at least a second abdomen, at least one experience of preterm labor earlier than 37 weeks of gestation, gestational age 10 to 28 weeks with an anxiety score above the Spielberger Anxiety Questionnaire (score 43 and above for anxiety Manifest and score 46 and above for hidden anxiety), literate, wanting to be pregnant, no history of using psychiatric drugs and hospitalization due to psychiatric problems, no history of infertility and recurrent miscarriage, no doctor advising to rest Absolute. Exclusion criteria: Conditions that affect the physiological state of the mother, such as diabetes mellitus, maternal indications for termination of pregnancy (severe preeclampsia, placental abruption, placenta previa with active bleeding), receiving psychotherapy.
Intervention groups
In the intervention group, in addition to receiving routine pregnancy care, women also participate in group sessions of 8 to 12 people based on mindfulness counseling. In the control group, women receive only routine pregnancy care.
Main outcome variables
Anxiety of pregnant women with a history of preterm labor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220511054815N1
Registration date: 2022-05-14, 1401/02/24
Registration timing: prospective

Last update: 2022-05-14, 1401/02/24
Update count: 0
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Sahar Mohammadikhass
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8331
Email address
s.mohammadikhass@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-10, 1401/03/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mindfulness-based counseling on Pregnant women with anxiety disorders experience of Preterm birth
Public title
The Effect of Mindfulness-based counseling on Pregnant women with anxiety disorders experience of Preterm birth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with at least a second pregnancy, at least one experience of preterm labor earlier than 37 weeks of gestation, gestational age 10 to 28 weeks with an anxiety score above the Spilberger Anxiety Questionnaire (43 and above for overt anxiety and 46 and Higher for latent anxiety), literate, wanting to be pregnant, no history of using psychiatric drugs and hospitalization due to psychiatric problems, no history of infertility and recurrent miscarriage, no doctor advising to rest completely.
Exclusion criteria:
Conditions that affect the physiological state of the mother, such as diabetes mellitus, maternal indications for termination of pregnancy (severe preeclampsia, placental abruption, placenta previa with active bleeding), unwillingness to participate in further study, receiving psychotherapy.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are randomly divided into sixteen blocks of six and are assigned to intervention and control groups. In the intervention program, individuals are divided into groups of five or less. A random sequence of blocking is assigned to a specific person outside the research team and assigns each mother to one of two intervention or control groups.
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 Ahvaz University of Medical Sciences
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Science, Nursing and Midwifery School, Midwifery Department
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.AJUMS.REC.1401.054

Health conditions studied

1

Description of health condition studied
Anxiety of pregnant women with a history of preterm labor
ICD-10 code
F06.4
ICD-10 code description
اضطراب مادران باردار دارای سابقه زایمان زودرس

Primary outcomes

1

Description
Anxiety score of pregnant women in Spielberger Anxiety Questionnaire
Timepoint
Completion of Spielberger Anxiety Questionnaire before and after the intervention
Method of measurement
Spielberger Anxiety Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pregnant women with moderate to high anxiety scores receive 8 sessions of mindfulness-based group counseling for 8 consecutive weeks. The number of people in groups is 5 and the duration of each session will be about 120 minutes. Each session has an educational purpose and during the session, they perform mindfulness exercises. Homework is also recommended for women to practice mindfulness in everyday events.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahwaz city health centers
Full name of responsible person
Sahar Mohammadikhass
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Science, Nursing and Midwifery School, Midwifery Department
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311 0000
Email
s.mohammadikhass@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahar Mohammadikhass
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Science, Nursing and Midwifery School, Midwifery Department
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 916 308 2084
Email
s.mohammadikhass@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sahar Mohammadikhass
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Science, Nursing and Midwifery School, Midwifery Department
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311 0000
Email
s.mohammadikhass@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahar Mohammadikhass
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Science, Nursing and Midwifery School, Midwifery Department
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311 0000
Email
s.mohammadikhass@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahar Mohammadikhass
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Science, Nursing and Midwifery School, Midwifery Department
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311 0000
Email
s.mohammadikhass@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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