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Study of the effect of supportive counseling on anxiety, stress, and perceived control of pregnant women with preterm labor

Protocol summary

Study aim
Determination of the effect of supportive counseling on anxiety, stress, and perceived control of pregnant women with preterm labor
Design
In this study, 60 inpatient pregnant women with gestational age between 24 to 36 weeks entered the study at the Ayatollah Rohani Hospital of the Babol city. An independent statistician to research team allocates participants based on simple random method using computer, with random allocation sequence and equal probability (1:1), into two groups A and B (Intervention and control).
Settings and conduct
Participants with preterm labor,who have conditions for entry the study,will be divided randomly into two groups. The participants of group A (30 persons) receive combination of standard medical care of preterm birth and individual supportive counseling for six consecutive days. The participants of group B (30 persons) receive only standard medical care of preterm birth. All participants fill three questionnaires including; State-Trait Anxiety Inventory of Spielberger (STAI), Revised Prenatal Distress Questionnaire, and Perceived control over pregnancy, at the beginning of the study and the end of the study (six days later).
Participants/Inclusion and exclusion criteria
Inclusion criteria: inpatient pregnant women with preterm labor and gestational age between 24 and 36 weeks, level of education higher than primary school, informed consent. Exclusion criteria: Bleeding, Infection, Hypertension, Pregnancy Induced Hypertension, Gestational Diabetes, Delivery
Intervention groups
Intervention group: Combination of standard medical care of preterm birth with supportive counseling Control group: standard medical care
Main outcome variables
Anxiety, Stress, Perceived control

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110228005931N6
Registration date: 2018-09-18, 1397/06/27
Registration timing: registered_while_recruiting

Last update: 2018-09-18, 1397/06/27
Update count: 0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Mahbobeh Faramarzi
Name of organization / entity
Babol University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 4456
Email address
m.faramarzi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of supportive counseling on anxiety, stress, and perceived control of pregnant women with preterm labor
Public title
The effect of supportive counseling on anxiety of pregnant women with preterm labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
inpatient pregnant women with preterm labor and gestational age of between 24 and 36 weeks, level of education higher than primary school, informed consent
Exclusion criteria:
Bleeding, Infection, Hypertension, Pregnancy Induced Hypertension, Gestational Diabetes, Delivery
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
An independent statistician to research team will be allocates the participants based on simple random method using website www.random.org and an allocation ratio of 1: 1 to 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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2018-07-07, 1397/04/16
Ethics committee reference number
IR.MUBABOL.REC.1397.031

Health conditions studied

1

Description of health condition studied
Preterm labor
ICD-10 code
060
ICD-10 code description
Preterm labour and delivery

Primary outcomes

1

Description
Anxiety score in Strait-Trait Anxiety Spielberger
Timepoint
At binging the study and end of the study (six day after beginning)
Method of measurement
Strait-Trait Anxiety Inventory

2

Description
ُStress score in Revised Prenatal Distress Questionnaire
Timepoint
At binging the study and end of the study (six day after beginning)
Method of measurement
Revised Prenatal Distress Questionnaire (NUPDQ)

3

Description
scores of Perceived Control over pregnancy
Timepoint
At binging the study and end of the study (six day after beginning)
Method of measurement
Perceived Control over pregnancy

Secondary outcomes

1

Description
Neonatal and pregnancy outcomes
Timepoint
Postpartum
Method of measurement
Questionnaire and complete the checklist using file

Intervention groups

1

Description
Intervention group: The participants of this group receive combination of standard medical care for preterm birth with individual supportive counseling by a trained psychologist. The aim of the counseling is reduction of the fears and concerns of the patient with supportive counseling techniques. Also, the participants practice relaxation techniques such as deep breathing and progressive relaxation three times a day . Supportive counseling sessions are consisted of 6 sessions per hour for 6 consecutive days. If the patient discharges during the study, the counseling is provided by a telephone conservation.
Category
Behavior

2

Description
Control group: Participants receive standard medical care for preterm birth.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatolah Rohani Haspital
Full name of responsible person
Mahbobeh Mirtabar
Street address
Ayatolah Rohani Haspital, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1219 9592
Email
dr.dini@mubabol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Of ayatollah Amoli
Full name of responsible person
Arsalan Khan Mohamadi
Street address
Islamic Azad University Of ayatollah Amoli, old rode of Amol-Babol
City
Amol
Province
Mazandaran
Postal code
Post box- 678
Phone
+98 11 4321 7000
Email
khanmohammadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Of ayatollah Amoli
Proportion provided by this source
20
Public or private sector
Private
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
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faraamrzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1219 9592
Email
mahbob330@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
َAssociate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1219 9592
Email
mahbob330@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
mahbob330@yahoo.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
Not applicable
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