IRCT | Effect of family visit everyday on anxiety and depression in pregnant women with preterm rupture of membranes (PROM) hospitalized in the third trimester of pregnancy.

Protocol summary

Study aim: Effect of family visit everyday on anxiety and depression in pregnant women with preterm rupture of membranes (PROM) hospitalized in the third trimester of pregnancy.
Design: Clinical trial with intervention and control group, 70 patients, with parallel groups, single blinded, randomized.
Settings and conduct: Background: Anxiety and depression in pregnant women. Patients will be divided randomly into two groups, intervention (35 patients) and control group (35 patients).Patients will be admitted to separate rooms to be unaware of the type of intervention they receive each other. Both groups will be receive all routine care and medication but in intervention group, along with the standard care, will walk each day for half an hour and at least 5 days a week with a spouse or a close member of the family in the hospital's yard. The questionnaire for depression and anxiety is then re-evaluated within a week up to 3 consecutive weeks.The assignment sequence will be performed by a person who has no role in the entry of participants in the research, data collection and analysis of the data.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Women aged 20-35 years; have a steady family status Exclusion criteria:Having a history of depression or anxiety; gestational age greater than 38 weeks
Intervention groups: The intervention group: Along with the standard care, will walk each day for half an hour and at least 5 days a week with a spouse or a close member of the family in the hospital's yard. Control group: Will receive the care and medications prescribed by the respective physician.
Main outcome variables: Depression and anxiety

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20180227038879N3

Registration date: 2018-12-01, 1397/09/10

Registration timing: registered_while_recruiting

Last update: 2018-12-01, 1397/09/10

Update count: 0
Registration date: 2018-12-01, 1397/09/10

Registrant information: Name

Fatemeh Abbasalizadehf

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 41 3553 9161

Email address

abbasalizadehf@tbzmed.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-11-21, 1397/08/30
Expected recruitment end date: 2019-11-21, 1398/08/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effect of family visit everyday on anxiety and depression in pregnant women with preterm rupture of membranes (PROM) hospitalized in the third trimester of pregnancy.

Public title: The effect of daily family visits on anxiety and depression in pregnant women admitted to hospital
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Women with aged between 20-35 years The desire to participate in the study The possibility of a daily presence of at least 5 days a week for for the patients husband or a close family member in hospital preterm rupture of membranes

Exclusion criteria:

Having a history of depression and anxiety Gestational age greater than 38 weeks
Age: From 20 years old to 35 years old
Gender: Female

Phase

N/A

Groups that have been masked

Care provider

Sample size

Target sample size: 70

Randomization (investigator's opinion)

Randomized

Randomization description

To hide allocations (Allocation Concealment), Will be written type of intervention on paper and placed inside matte envelopes in numerical order, respectively. The assignment sequence will be performed by a person who has no role in the entry of participants in the research, data collection and analysis of the data. Random Allocation of four and six will be done using the site (http://www.random.org).

Blinding (investigator's opinion)

Single blinded

Blinding description

To hide allocations (Allocation Concealment), Will be written type of intervention on paper and placed inside matte envelopes in numerical order, respectively. The assignment sequence will be performed by a person who has no role in the entry of participants in the research, data collection and analysis of the data.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee Of Tabriz University Of Medical Sciences

Street address

Third Floor., Central Building of Number2., Golgasht Street

City

Tabriz

Province

East Azarbaijan

Postal code

5138665793
Approval date: 2018-08-27, 1397/06/05
Ethics committee reference number: IR.TBZMED.REC.1397.463

Health conditions studied

1

Description of health condition studied: Premature rupture of membranes
ICD-10 code: O42
ICD-10 code description: Premature rupture of membranes

Primary outcomes

1

Description: Depression
Timepoint: At the beginning of the study and the end of the first, second and third weeks of the study
Method of measurement: Depression and Anxiety questionnaire

2

Description: Anxiety
Timepoint: At the beginning of the study and the end of the first, second and third weeks of the study
Method of measurement: Depression and Anxiety questionnaire

Secondary outcomes

empty

Intervention groups

1

Description: "Intervention group:" In addition to standard care, they will walk each day for half an hour and at least 5 days a week with a spouse or a close family member in the hospital's yard,up to 3 consecutive weeks and at the end of the study if the patients in the intervention group continue to be admitted, It is possible for them to continue the study conditions until delivery and if the delivery is earlier than a week, patients are excluded from the study.
Category: Behavior

2

Description: "Control group" will receive all routine care and medication.
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Alzahra Hospital

Full name of responsible person

Fatemeh Abbasalizadeh

Street address

Alzahra Hospital., South Artesh St.

City

Tabriz

Province

East Azarbaijan

Postal code

5138665793

Phone

+98 41 3553 9161

Email

lahroudin@gmail.com

1

Sponsor: Name of organization / entity

Vice chancellor for Research,Tabriz University Of Medical Sciences

Full name of responsible person

Abolghasem Juiban

Street address

Third Floor., Central Building of Number2., Golgasht Street

City

Tabriz

Province

East Azarbaijan

Postal code

5138665793

Phone

+98 41 3553 9161

Fax

Email

ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Vice chancellor for Research,Tabriz 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

Tabriz University of Medical Sciences

Full name of responsible person

Fatemeh Abbasalizadeh

Position

Professor Obstetricians and Gynecologists

Latest degree

Subspecialist

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Tabriz University Of Medical Sciences., Golgasht Street

City

Tabriz

Province

East Azarbaijan

Postal code

5138665793

Phone

+98 41 3553 9161

Email

lahroudin@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tabriz University of Medical Sciences

Full name of responsible person

Fatemeh Abbasalizadeh

Position

Professor Obstetricians and Gynecologists

Latest degree

Subspecialist

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Tabriz University Of Medical Sciences, Golgasht Street

City

Tabriz

Province

East Azarbaijan

Postal code

5138665793

Phone

+98 41 3553 9161

Email

lahroudin@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Tabriz University of Medical Sciences

Full name of responsible person

Fatemeh Abbasalizadeh

Position

Professor Obstetricians and Gynecologists

Latest degree

Subspecialist

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Tabriz University Of Medical Sciences, Golgasht Street

City

Tabriz

Province

East Azarbaijan

Postal code

5138665793

Phone

+98 41 3553 9161

Fax

Email

lahroudin@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

Effect of family visit everyday on anxiety and depression in pregnant women with preterm rupture of membranes (PROM) hospitalized in the third trimester of pregnancy.