Determining the Effect of Supportive Care Counseling on Anxiety and Quality of Life in Pregnant Women with a History of Abortion
Design
The present study is a clinical trial study in which first the selection of samples by stratified method and after the selection of samples by four block method are assigned to two groups of intervention and control.
Settings and conduct
This Counseling is Performed in Selected Comprehensive Health Centers of Isfahan on Pregnant Women with a History of abortion who Suffer from Anxiety and Reduced Quality of life, according to Swanson Theory, in 5 Stages and in three Sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having a Current Gestational Age of 8 Weeks or More with Ultrasound Confirmation
؛ Wanting a Current Pregnancy
؛ Having a Miscarriage under 20 Weeks in a Previous Pregnancy During the Past Year
؛ No History of Specific Mental Illness
؛ Minimum Literacy
؛ Not Having a Living Child in the Family
Exclusion criteria:
Reluctance to Continue Participating in the Study
;Loss of Pregnancy
; Occurrence of Accidents and Major Stresses during the Intervention such as the Loss of Loved Ones
; Migrating a pregnant woman
Intervention groups
The Intervention Group of Pregnant Women with a History of Abortion who have Experienced Anxiety and reduced quality of Life and the Effect of Supportive Care Counseling on their Anxiety and Quality of Life are Measured and the Control Group for whom no Action is Taken and Compared with the Intervention Group.
Main outcome variables
Anxiety Disorder
Increase the Quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210827052302N1
Registration date:2021-11-12, 1400/08/21
Registration timing:registered_while_recruiting
Last update:2021-11-12, 1400/08/21
Update count:0
Registration date
2021-11-12, 1400/08/21
Registrant information
Name
Z0hre Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3442 1622
Email address
zohre.kiani81@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2021-12-11, 1400/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Supportive Care Counseling on Anxiety and Quality of Life of Pregnant Women with a History of Abortion
Public title
The effect of midwifery counseling on anxiety and lifestyle in pregnant women who have experienced abortion.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a Current Gestational Age of 8 Weeks and more with Ultrasound Approval
Wanted Current Pregnancy
Having a Miscarriage under 20 Weeks in a Previous Pregnancy in the Past Year
No History of Specific Mental Illness
Minimum Literacy
Not Having a Living Child in the Family
Exclusion criteria:
Reluctance to Continue Participating in the Study
Loss Of Pregnancy
Occurrence of Unfortunate Events and Great Stress During the Intervention such as the Loss of Loved Ones
Immigration of the Pregnant Mother
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, which is the stage of selecting samples, the class is done in such a way that first a list of comprehensive health centers in different areas of Isfahan is prepared and then two centers are randomly selected in each area. Then, the number of clients in each center Determine the eligibility of the study and then the estimated sample size in relation to the number of clients in each center is determined, then in each center by blocks with size 4 with the help of https://www.sealedenvelope.com. And control allocation It should be noted that to hide the random allocation stage will be done by someone other than the researcher.
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 Iran University of medical Sciences
Street address
5th Floor, Headquarters, Iran University of Medical Sciences, Between Chamran and Sheikh Fazlolah streets, Hemat Hwy
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-12-07, 1399/09/17
Ethics committee reference number
IR.IUMS.REC.1399.974
Health conditions studied
1
Description of health condition studied
Spontaneous Abortion
ICD-10 code
003
ICD-10 code description
Spontaneous abortion
Primary outcomes
1
Description
Anxiety
Timepoint
The beginning of the study and 4 and 8 week after end of study
Method of measurement
Pregnancy Related Anxiety Questionnaire Vanden Berg 1989
Secondary outcomes
1
Description
Quality of Life
Timepoint
The beginning of the study and 4 and 8 week after end of intervention
Method of measurement
Ware and Sherbourne questionnaire ( SF-36 )
Intervention groups
1
Description
Intervention Group: Pregnant Mothers who have been Confirmed by their Pregnancy Ultrasound and have Registered their Pregnancy History in a Comprehensive Health Center and have Inclusion Criteria and have been randomly Placed in the Intervention Group, Details of the Plan will be Contacted. They are Invited to Participate in this Project. In the first Session of their Presence in the Center after Obtaining Satisfaction and Completing the Demography questionnaire and Wendenberg pregnancy Anxiety Questionnaire and the Wire and Sherbon Quality of Life Questionnaire, the first Counseling Session based on 5 Stages of Swanson Theory is held with the Presence of the Center Psychologist. a week later, second session and The third Week, the third Session is held and 4 Weeks and 8 Weeks after the Intervention, the Questionnaires are Completed again by the Intervention Group.
Category
Lifestyle
2
Description
Control Group: Pregnant Mothers who have been Confirmed by their Pregnancy Ultrasound and have filed a Pregnancy Record at the Comprehensive Health Center and have inclusion criteria and have been randomly placed in the control group will be contacted and the details of the plan will be explained. They are invited to participate in the project. In the first session of their presence in the center after obtaining consent, they complete the Demographic and Wendenberg Pregnancy Anxiety Questionnaire and the Wire and Sherbon Quality of Life Questionnaire. This group does not receive any intervention and 4 and 8 weeks after the end of the intervention, the Wendenberg Pregnancy Anxiety Questionnaire and the quality of life of Wire and Sherbon are completed by this group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfahan Health Center
Full name of responsible person
dr Masoomeh kheirkhah
Street address
School of Nursing and Midwifery, Rashid Yasemi St, Above of Vanak Sq, Valiasr St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
shivakheirkhah1345@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Masoomeh Kheirkhah
Street address
School of Nursing and Midwifery, Rashid Yasemi St, Above of Vanak Sq, Valiasr St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
shivakheirkhah1345@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
dr Masoomeh kheirkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing and Midwifery, Rashid Yasemi St, Above of Vanak Sq, Valiasr St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
shivakheirkhah1345@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
dr Masoomeh kheirkhah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing and Midwifery, Rashid Yasemi St, Above of Vanak Sq, Valiasr St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
shivakheirkhah1345@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
dr Masoomeh kheirkhah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing and Midwifery, Rashid Yasemi St, Above of Vanak Sq, Valiasr St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
shivakheirkhah1345@gmail.com
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome is shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All researchers, midwives and doctors
Under which criteria data/document could be used
Documentary researchers can be used for scientific advancement. It is possible to access the data by sending an email to the supervisor. Email shivakheirkhah1345@gmail.com
From where data/document is obtainable
Scientific responsible for studying Masoumeh Kheirkhah Email shivakheirkhah1345@gmail.com
What processes are involved for a request to access data/document
After confirmation of the research assistant by email to the supervisor email shivakheirkhah1345@gmail.com