IRCT | Study on the effect of pregnant women's training about attachment behaviors on maternal-fetal attachment measure in unplanned pregnancies (a randomized clinical trial)

Protocol summary

Study aim: ِDetermine the effect of pregnant women's training about attachment behaviors on maternal-fetal attachment measure in unplanned pregnancies
Design: A controlled randomized clinical trial, single blind, with a factorial design on 68 pregnant mothers in two group of attachment behaviors training group and the control group
Settings and conduct: Recruitment will be done in office of family physicians and health centers in Sari. After taking informed consent from eligible mothers, they will be trained about maternal-fetal attachment behaviors in small groups including 3-5 mothers for three sessions of 90 minutes, every 3-4 days. َAlso a booklet and check list will be given to the mothers to perform the behaviors for 4 weeks. The control group will be received only pregnancy routine cares. Demographic questionnaire, London Measure of Unplanned Pregnancy, Cranley's Maternal-Fetal Attachment Scale, Spielberger Anxiety Inventory, Edinburgh Postnatal Depression Scale and Prenatal Distress Questionnaire will be completed initially and after 4 weeks (except of demographic and London Questionnaires). Data analyzer will be blind.
Participants/Inclusion and exclusion criteria: Pregnant women with unplanned pregnancy (score 0-3 based on London measure), 20-32 weeks of gestation age, Literacy at least grade 8, Single fetus Lack of medical problems and obstetrics risk factors such as signs of preterm labor, history of infertility, history of fetal or child loss, disrupted tests of fetal health, diabetes, preeclampsia and bleeding, lack of severe anxiety, depression or worry, lack of addiction
Intervention groups: The intervention group includes pregnant mothers who will be trained about maternal- fetal attachment behaviors. The control group are pregnant mothers who will be just received routine cares of pregnancy.
Main outcome variables: maternal-fatal attachment

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20091130002792N3

Registration date: 2018-10-29, 1397/08/07

Registration timing: prospective

Last update: 2018-10-29, 1397/08/07

Update count: 0
Registration date: 2018-10-29, 1397/08/07

Registrant information: Name

Marjan Ahmadshirvani

Name of organization / entity

Mazandaran University Of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 15 1226 7345

Email address

mashirvani@mazums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-11-22, 1397/09/01
Expected recruitment end date: 2019-06-22, 1398/04/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Study on the effect of pregnant women's training about attachment behaviors on maternal-fetal attachment measure in unplanned pregnancies (a randomized clinical trial)

Public title: Effect of training on maternal-fetal attachment in unplanned pregnancies
Purpose: Education/Guidance
Inclusion/Exclusion criteria: Inclusion criteria:

Unplanned pregnancy (score 0-3 based on London measure) 20-32 weeks of gestation age Literacy at least grade 8 Single fetus Lack of medical problems and obstetrics risk factors such as signs of preterm labor, history of infertility, history of fetal or child loss, disrupted tests of fetal health, diabetes, preeclampsia and bleeding lack of severe anxiety, depression or worry lack of addiction

Exclusion criteria:

Refuse to continue participating in the study Inaccessible during follow-up Failure to implement more than 50% of recommendations during the study Occurrence of obstetrics or medical problems during the study such as preterm labor, PROM, reduce of fetal movements and indications of termination of pregnancy Losing relatives during the study or last 6 months
Age: From 15 years old to 49 years old
Gender: Female

Phase

N/A

Groups that have been masked

Data analyser

Sample size

Target sample size: 68

Randomization (investigator's opinion)

Randomized

Randomization description

Simple Randomization with cards (intervention group A and control group B)

Blinding (investigator's opinion)

Single blinded

Blinding description

Because blinding of participants and researcher is impossible in this study, only data analyzer will be blind.

Placebo

Not used

Assignment

Factorial

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Mazandaran University of Medical Sciences

Street address

Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences, Moalem sq.

City

Sari

Province

Mazandaran

Postal code

4817844718
Approval date: 2018-09-26, 1397/07/04
Ethics committee reference number: IR.MAZUMS.REC.1397.3029

Health conditions studied

1

Description of health condition studied: Maternal-fetal attachment
ICD-10 code
ICD-10 code description

2

Description of health condition studied: Anxiety
ICD-10 code: F41.1
ICD-10 code description: Generalized anxiety disorder

3

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

4

Description of health condition studied: Worry
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Score of maternal-fetal attachment based on the Cranley's Maternal-Fetal Attachment Scale
Timepoint: At the beginning of the study and 4 weeks later
Method of measurement: Cranley's Maternal-Fetal Attachment Scale

Secondary outcomes

1

Description: Score of anxiety based on the Spielberger Anxiety Inventory
Timepoint: At the beginning of the study and 4 weeks later
Method of measurement: Spielberger State-Trait Anxiety Inventory

2

Description: Score of depression based on the Edinburgh Depression Scale
Timepoint: At the beginning of the study and 4 weeks later
Method of measurement: Edinburgh Depression Scale

3

Description: Score of worry based on the Prenatal Distress Questionnaire
Timepoint: At the beginning of the study and 4 weeks later
Method of measurement: Prenatal Distress Questionnaire

Intervention groups

1

Description: Intervention group: mothers' Training about maternal-fetal attachment behaviors will be performed in small groups including 3-5 mothers for three sessions of 90 minutes, every 3-4 days. The training will include verbal explanations about physical and psychological changes during pregnancy and their outcomes, fetal growth, the concept of fetal attachment and its benefits, childbirth process and nutritional tips. The practical training will include touch and pat fetus from the abdomen, counting fetal movements, listen fetal heart, talk with fetus, relaxation and look at ultrasound image of fetus. ّFor performing the mentioned training in home, a booklet and a CD including recorded voice of fetal heart, animation of fetal growth and relaxation guide will be given to mothers.
Category: Behavior

2

Description: Control group: mothers will be received routine cares of pregnancy
Category: N/A

Recruitment centers

1

Recruitment center: Name of recruitment center

Office of family physicians and health centers in Sari

Full name of responsible person

Parastou Mahmoudi

Street address

School of Nursing & Midwifery, Vesal St.

City

Sari

Province

Mazandaran

Postal code

4816715793

Phone

+98 11 3336 7342

Email

p.mahmoudi.p@gmail.com

1

Sponsor: Name of organization / entity

Mazandaran University of Medical Sciences

Full name of responsible person

Dr. Majid Saeedi

Street address

Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences, Moalem sq.

City

Sari

Province

Mazandaran

Postal code

4817844718

Phone

+98 11 3325 7230

Email

majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Sari 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

Mazandaran University of Medical Sciences

Full name of responsible person

Marjan Ahmad Shirvani

Position

Lecturer

Latest degree

Master

Other areas of specialty/work

Midwifery

Street address

School of Nursing and Midwifery, Vesal st.

City

Sari

Province

Mazandaran

Postal code

4816715793

Phone

+98 11 3336 7342

Fax

Email

MAShirvani@mazums.ac.ir

Web page address

Person responsible for scientific inquiries

Contact: Name of organization / entity

Mazandaran University of Medical Sciences

Full name of responsible person

Marjan Ahmad Shirvani

Position

Lecturer

Latest degree

Master

Other areas of specialty/work

Midwifery

Street address

School of Nursing and Midwifery, Vesal st.

City

Sari

Province

Mazandaran

Postal code

4816715793

Phone

+98 11 3336 7342

Fax

Email

MAShirvani@mazums.ac.ir

Web page address

Person responsible for updating data

Contact: Name of organization / entity

Mazandaran University of Medical Sciences

Full name of responsible person

Marjan Ahmad Shirvani

Position

Lecturer

Latest degree

Master

Other areas of specialty/work

Midwifery

Street address

School of Nursing and Midwifery, Vesal st.

City

Sari

Province

Mazandaran

Postal code

4816715793

Phone

+98 11 3336 7342

Fax

Email

MAShirvani@mazums.ac.ir

Web page address

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: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: It depends on who and for what purpose they are requesting information
When the data will become available and for how long: Available from 3 months after printing results
To whom data/document is available: Researchers in academic and science centers
Under which criteria data/document could be used: To use in systematic reviews or meta analysis and use the protocol in others researches or in the health care system with respecting the rights of the researchers.
From where data/document is obtainable: Marjan Ahmad Shirvani MAShirvani@mazums.ac.ir
What processes are involved for a request to access data/document: Submit an application including organization affiliation, the purpose of the request and how to observe the rights of the researchers. A request will be answered no later than one month after receipt.
Comments

Study on the effect of pregnant women's training about attachment behaviors on maternal-fetal attachment measure in unplanned pregnancies (a randomized clinical trial)