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The effect of invitro fertilization (IVF) mothers'preparation for maternal role playing on maternal self-steem and stress

Protocol summary

Summary
Considering the challenging nature of mothering for the first time and especially using assisted reproductive techniques, a Randomized Controlled Clinical Trial study will be conducted on pregnant mothers using IVF fertility assisted reproductive technique with the gestational age between 12 weeks to end of 20 weeks, with a history of at least 2 years of primary infertility and without a history of mental diseases, with the aim to determine the effect of preparation of fertilized mothers through intrauterine fertilization on maternal self-esteem and stress in Royan Research Institute. 60 people of these mothers who have the conditions for inclusion in the study will be selected by available sampling method and will be randomly placed in to two test and control groups , a mother’ preparation program for the test group will be implemented with maternal care content in pregnancy (nutrition, sleeping and rest, exercise and body condition correction), mother's stress control ways, education about the stages of growing and development of the fetus and baby, attachment to the fetus, preparation for delivery and care for the baby, relationship with husband during pregnancy and after delivery, care taking of her during pregnancy and after delivery in 4 sessions in 2-hours for 4 weeks . At first, information collecting tools including demographic questionnaire, Pregnancy's Worries and Stress Questionnaire, and Maternal Self-Report Inventory for maternal self-esteem are provided to the mothers of the two groups and they are asked to complete the questionnaires after obtaining informed consent,. The mothers’ preparation program of the test group will be implemented. Information of two groups will be re-collected in the fourth week and one month after completing the initial questionnaires. The educational content will be given to mothers of the control group as educational pamphlets after completing the final questionnaires. Finally, the data are analyzed using SPSS version 21, and descriptive and inferential statistics will be used according to the goals of the research.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061734592N1
Registration date: 2017-07-09, 1396/04/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-09, 1396/04/18
Registrant information
Name
Atefe Salimi Akin Abadi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 4474 1308
Email address
atefe-salimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of invitro fertilization (IVF) mothers'preparation for maternal role playing on maternal self-steem and stress
Public title
The effect of invitro fertilization (IVF) mothers' preparation on maternal self-steem and stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for the study: fertile women treated with assisted reproductive techniques in vitro fertilization (IVF), gestational age between 12 weeks to the end of 20 weeks, history of least 2 years of infertility and no history of mental illness. Exclusion criteria from the study: mothers fertilized with other methods of assisted reproductive technology, secondary infertility, gestational age less than 12 weeks and more than 20 weeks,history of infertility less than 2 years, a history of mental illness, mothers who have Preterm delivery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Beheshti University of Medical Sciences, school of nursing and midwifery
Street address
school of nursing and midwifery, Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2016-10-24, 1395/08/03
Ethics committee reference number
IR.SBMU.PHNM.1395.534

Health conditions studied

1

Description of health condition studied
invitro fertilization (IVF) mothers
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization

Primary outcomes

1

Description
Maternal Self Steem
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention.
Method of measurement
Maternal Self-Report Inventory-Short Version

2

Description
Maternal stress
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention.
Method of measurement
Inventory of stress and worry of pregnancy

Secondary outcomes

empty

Intervention groups

1

Description
The content of the mother's preparation program to play mothering role in optimal way and investigating its effect on maternal stress and self-esteem, will include maternal care during pregnancy (nutrition, sleeping rate and rest, exercise and body condition correction), ways to control of mother's stress, training on the stages of development and growing of the fetus and the baby, attachment to the fetus, preparation for delivery and caretaking baby, relationship with the husband during pregnancy and after delivery, self-care during pregnancy and after delivery. Additionally, the evaluation needs form of educations for pregnancy period will be given to mothers by the researcher to review and resolve other educational needs of mothers. This content will be given to mothers after a complete overview of valid articles and resources, in addition to attending training in preparation sessions in the form of educational pamphlets. The number of sessions will be 4 sessions of 2 hours for 4 weeks in this study due to the effectiveness of the number of mother's preparation sessions on mother's stress in the paper by Pouafshar et al. (2005), with the title of the effect of delivery preparation training on stress during pregnancy and delivery in first pregnant women referring to social security clinics in Mashhad. At first, information collecting tools including demographic questionnaire, Pregnancy's Worries and Stress Questionnaire, and Maternal Self-Report Inventory for maternal self-esteem are provided to the mothers of the two groups and they are asked to complete the questionnaires after obtaining informed consent. The contents regarding the goals of the preparation program, maternal care during pregnancy (nutrition, sleeping rate and rest, exercise and physical situation correction) control the mother's stress and relaxation will be thought at the first session of the preparation program, relaxation will be exercised at the end of the session slowly and mothers are asked to write down the frequency of relaxation, the purpose of writing the frequency of relaxation performed by the mother is to increase attention and to remind this matter to mother at home. The second session will include the presentation of contents about fetus growing and development, attachment to the fetus, and education of fetus attachment enhancement behaviors. At the end of the session, mothers will be asked to write the times of talking with the fetus, calling the fetus and touching the abdomen to feel the emotions of the fetus's motions, the purpose of writing the frequency of doing attachment behaviors by mother is to increase attention and to remind this matter to the mother at home. Educational contents for the third session include explanations about the preparation for delivery, baby take caring, infant's developmental stages and attachment to the baby, the sense of completeness of the mother is facilitated by learning how to care for the infant and how to understand his/her reactions and respond appropriately to them, such as calming down the infant in crying time. At the fourth session, contents will be provided about relationship with husband during pregnancy and after delivery, self-take caring during pregnancy and after delivery. Sessions will be face-to-face education in groups of up to 5-6 people using PowerPoint, speech and questions and answers, and educational pamphlets will be given to mothers. The probable questions of the mothers will be answered at the end of each session. Information from the mothers of the test group will be collected and compared immediately after the end of the fourth session and four weeks after the intervention. The samples are free in responsive to the questionnaire and the information is recorded and kept confidential. The researcher will be available at the time of completing the tools to answer any probable questions.
Category
Other

2

Description
The samples are contacted by the phone and made an appointment with them after assigning 30 mothers to the control group. At first, information collecting tools including demographic questionnaire, Pregnancy's Worries and Stress Questionnaire, and Maternal Self-Report Inventory for maternal self-esteem are provided to the mothers of the two groups and they were asked to complete the questionnaires after obtaining informed consent. Information from the mothers of the test group will be collected and compared again immediately after the end of the fourth session and four weeks after the completing the primary questionnaire. It should be noted that in order to observe ethics in the research, educational content will be given to mothers of the control group as educational pamphlets after completing the final questionnaires.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Dr Mahrokh Dolatian
Street address
School of Nursing and Midwifery, Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
t 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Atefe Salimi Akin Abadi
Position
ms student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+98 88 6553 6671
Fax
Email
atefe-salimi@sbmu.ac.iratefe.salimi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Atefe Salimi Akin Abadi
Position
ms student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 88 6553 6671
Fax
Email
atefe-salimi@sbmu.ac.iratefe.salimi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Atefe Salimi Akin Abadi
Position
MS student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 88 6553 6671
Fax
Email
atefe-salimi@sbmu.ac.iratefe.salimi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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