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The effect of resiliency training on mental health of pregnant women with unwanted pregnancy

Protocol summary

Study aim
Investigating the effect of resiliency training on mental health of pregnant women with unwanted pregnancy
Design
Clinical trial with control group, with parallel groups, randomized, on 60 pregnant women with unwanted pregnancies.
Settings and conduct
After obtaining written consent, they enter the research. First, the Goldberg mental Health Questionnaire and the Connor Davidson Resilience Scale will be completed. The control group will receive the routine pregnancy care. In the intervention group, in addition to routine pregnancy care, a resilience training program will be held once a week of 6 group training sessions with 10 to 15 people, lasting 60- 90 minutes; with educational methods of scheduled lectures, working group, question and answer, and group discussion. Immediately and one month after the completion of the educational intervention, the resilience scale and the mental health questionnaire will be completed. The data will be analyzed by SPSS Software Editing 16 at a significance level of 0.05.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with unwanted pregnancy, age 18 to 35 years, gestational age 12 to 20 weeks, no medical contraindications to maintain pregnancy, no use of drugs and psychotropic drugs, resilience score less than 50, general health score 23 to 60; Conditions of non-admission:Pregnant women with a history of serious mental illness, pregnant women with a history of recurrent miscarriage, women with multiple pregnancies .
Intervention groups
Including 30 women attending to the comprehensive health center assigned to the intervention group and 30 women attending to the health center assigned to the control group
Main outcome variables
Mental health, Resilience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200630047968N1
Registration date: 2020-08-05, 1399/05/15
Registration timing: registered_while_recruiting

Last update: 2020-08-05, 1399/05/15
Update count: 0
Registration date
2020-08-05, 1399/05/15
Registrant information
Name
Marjan Naderpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 1651
Email address
naderpourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resiliency training on mental health of pregnant women with unwanted pregnancy
Public title
The effect of resiliency training on mental health of pregnant women with unwanted pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with unwanted pregnancies Age 18 to 35 years Mild and/or moderate problem of mental health based on the mental health questionnaire (score of 23 to 60 ) Low resilience based on the resilience scale (score less than 50) Written consent form
Exclusion criteria:
Failure to diagnose abnormalities in the fetus (according to screening of the first or second trimester or anomaly scan of fetus Lack of medical prohibition to maintain pregnancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to prevent interaction and exchange of information between individuals in the two groups, three centers were assigned to each group by random allocation. Random allocation was done in such a way that the selected health centers (6 centers) were randomly divided into two groups (3 centers in each group). The names of the centers were written on a piece of paper and placed in a lottery bag. The first sheet that was randomly removed from the bag was assigned to the intervention group and the second sheet to the control group and continued until the end of the sheets.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor and data analyser of the outcomes will be unaware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی مشهد
Street address
opposite to University Street 18, University Street, Mashhad University of Medical Sciences, Khorasan Razavi, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
051 38412081
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.022

Health conditions studied

1

Description of health condition studied
unwanted pregnancy
ICD-10 code
Z64.0
ICD-10 code description
Problems related to unwanted pregnancy

Primary outcomes

1

Description
Mental health
Timepoint
The beginning of the study, immediately after the consultation sessions and one month after consultation sessions
Method of measurement
General Health Questionnaire

Secondary outcomes

1

Description
Resilience
Timepoint
The beginning of the study, immediately after the consultation sessions and one month after consultation sessions
Method of measurement
Connor Davidson Resilience Scale

Intervention groups

1

Description
Intervention group: First, the general health questionnaire and the screening scale of Connor and Davidson will be completed. Educational topics include resilience training, first session: pre-test, unwanted pregnancy, resilience generalities, second session: self-acceptance, emotion control and anger management, recognizing strengths and weaknesses, third session: boosting self-esteem, communication and dating, Session 4: Determining purpose and purposeful life, Session 5: cultivating a sense of spirituality and faith, Session 6: providing a summary of all sessions. Immediately and one month after end of the educational intervention, the Resilience Scale and the General Health Questionnaire will be completed.
Category
Lifestyle

2

Description
Control group: Control Group: First, the General Health Questionnaire and the Connor and Davidson Resilience Scale will be completed. The Control Group will receive only the routine pregnancy care. Immediately and one month later, the Resilience Scale and the General Health Questionnaire will be completed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health centers in Sabzevar
Full name of responsible person
Marjan Naderpour
Street address
Between Taleghani 25 and 27, Taleghani Street, Khorasan Razavi, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9614765836
Phone
+98 51 4422 1651
Email
naderpourm1@mums.ac.ir
Web page address
https://nurse.mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Opposite to University Street 18, University Street Mashhad University of Medical Sciences, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir
Grant name
Grant code / Reference number
981626
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Marjan Naderpour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Crossroad of the Doktora, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9614765836
Phone
+98 51 4422 1656
Email
naderpourm1@mums.ac.ir
Web page address
https://nurse.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Crossroad of the Doktora, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
moradim@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marjan Naderpour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Crossroad of the Doktora, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51138591511
Email
naderpourm1@mums.ac.ir
Web page address
https://nurse.mums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of this study will be provided to the library of the Faculty of Nursing and Midwifery of Mashhad for the use of students and research units as well as enthusiasts as the senior dissertation on midwifery. A copy of this study was also made available to relevant authorities upon request. Publication of the results in prestigious scientific and research journals will be done in compliance with the authors' rights in all publications resulting from this research project.
When the data will become available and for how long
Probably from the end of 1399
To whom data/document is available
Researchers, students and research units as well as other enthusiasts
Under which criteria data/document could be used
The use of thesis in articles or any scientific article is subject to the mention of the source and in accordance with the publication regulations of Mashhad University of Medical Sciences.
From where data/document is obtainable
Library of the School of Nursing and Midwifery of Mashhad
What processes are involved for a request to access data/document
Contact e-mail with supervisor and registered author
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