Investigating the Effect of Educational-psychological Support Counseling on Stress and Anxiety and Self-esteem in Women Hospitalized for Abortion treatment
Determining the impact of educational-psychological support counseling on stress, anxiety and self-esteem of women hospitalized for abortion treatment
Design
Clinical trial, with intervention and control group, unblinded, randomized based on block, sample size 100 patients.
Settings and conduct
This study was conducted on women hospitalized for abortion treatment at Afzalipur Hospital in Kerman in 1401. The intervention group received two educational counseling sessions, and the control group received routine training in the women's department.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Ability to speak and understand Farsi language; Being literate in reading and writing
exclusion criteria:
Samples who used consulting services outside the research during the study; Samples who suffered stressful events in their lives during the six months before the abortion until the end of the study
Intervention groups
Intervention group: In this group, educational-psychological support counseling is used, which is done in two counseling sessions. One session is the hospitalization time to receive the medicine and start the course of treatment and another session after the pregnancy content is completely removed.
Control group: trainings and routine care of the women's department.
Main outcome variables
Stress, self-esteem, anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220820055747N1
Registration date:2022-11-22, 1401/09/01
Registration timing:prospective
Last update:2022-11-22, 1401/09/01
Update count:0
Registration date
2022-11-22, 1401/09/01
Registrant information
Name
Farzaneh Yarahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8221
Email address
farzanehyarahmadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-26, 1401/09/05
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Educational-psychological Support Counseling on Stress and Anxiety and Self-esteem in Women Hospitalized for Abortion treatment
Public title
Investigating the Effect of Educational-psychological Support Counseling on Stress and Anxiety and Self-esteem
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All the women applying for abortion treatment to Kerman forensic medicine, whose fetuses have congenital abnormalities, after introducing the forensic medicine to three specialist doctors and the approval of these three specialists, succeeded in receiving abortion treatment license according to the instructions of the forensic medicine organization.
The ability to speak and understand the Persian language
Being literate in reading and writing
Not having a history of known mental illnesses or taking neuropsychiatric drugs
Pregnancy is desired
Be of Iranian race
In this study, the patient's gravidity is not considered
Exclusion criteria:
Samples who had used consulting services outside the research during the study.
Samples who suffered stressful events in their lives during the six months before the abortion until the end of the study.
Absence in more than one counseling session
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, The beginning of Haft Bagh Alavi
City
kerman
Province
Kerman
Postal code
76169-13555
Approval date
2022-05-22, 1401/03/01
Ethics committee reference number
IR.KMU.REC.1401.088
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress and anxiety score in DASS questionnaire
Timepoint
before the start of the intervention and immediately after its completion
Method of measurement
DASS stress and anxiety questionnaire
2
Description
Self-esteem in the Rosenberg questionnaire
Timepoint
before the start of the intervention and immediately after its completion
Method of measurement
Rosenberg self-esteem questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, educational-psychological support counseling is used for the counseling of the intervention group, which is done in two counseling sessions, one session during hospitalization to receive medication and the beginning of the course of treatment, and another session after the pregnancy content is completely removed. The content of this consultation includes the explanation of the abortion treatment process and the training of midwifery care necessary before the abortion treatment, the training of post-abortion care, the necessary training to reduce stress and anxiety, and training to have a healthy lifestyle in order to reduce stress and anxiety.
Category
Other
2
Description
Control group: This group learns the training and routine care of the women's department.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipur Kerman Hospital
Full name of responsible person
Farzaneh YarAhmadi
Street address
Kerman University of Medical Sciences, the beginning of Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 916 248 4194
Email
farzanehyarahmadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman University of Medical Sciences, the beginning of Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
farzanehyarahmadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Farzaneh YarAhmadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, the beginning of Haft Bagh Alavi
City
kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 916 248 4194
Email
farzanehyarahmadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farzaneh YarAhmadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, the beginning of Haft Bagh Alavi
City
kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 916 248 4194
Email
farzanehyarahmadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farzaneh YarAhmadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, the beginning of Haft Bagh Alavi
City
kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 916 248 4194
Email
farzanehyarahmadi@yahoo.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