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The effect of supportive counseling on self-esteem and self-efficacy of infertile women after IVF failure

Protocol summary

Study aim
The effect of supportive counseling on self-esteem and self efficacy of infertile women after IVF failure
Design
Clinical trial with control group with parallel groups, without blinding, randomized, on 70 patients, rand software was used for randomization
Settings and conduct
Phone call with infertile women ،a negative pregnancy test after using the first IVF In Milad Infertility Center, Mashhad
Participants/Inclusion and exclusion criteria
Diagnosis of primary infertility, Iranian and resident of Mashhad, no known medical disease, negative pregnancy test after using the first IVF Has a smartphone, consent to participate in the study
Intervention groups
Support intervention counseling group in 4 sessions (two face-to-face sessions and one virtual face-to-face session) each session for 45 to 60 minutes and a week with the content of the first session (face-to-face) reassuring and explaining (establishing a positive relationship, resolving misunderstandings and doubts Patient and pointing out potential abilities and potentials and reducing stress by clarifying and providing information and explanation on the topic under discussion (Jabkson relaxation training),Second and third sessions (individual-virtual): guidance, encouragement and persuasion (online virtual individual counseling with the content of the first session feedback, explanation of various assisted reproductive methods, treatment protocols, experience of successful mothers, providing success statistics of reproductive assistive methods), fourth session (Individual-face-to-face): Vacation (practicing the techniques of revealing and releasing emotion, psychological support by active and empathetic listening, and a positive and unconditional outlook on life) is offered
Main outcome variables
The main outcomes are the self-esteem score and the infertility self-efficacy score.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210407050883N1
Registration date: 2021-05-25, 1400/03/04
Registration timing: prospective

Last update: 2021-05-25, 1400/03/04
Update count: 0
Registration date
2021-05-25, 1400/03/04
Registrant information
Name
Manijeh Shafaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
shafaghim2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive counseling on self-esteem and self-efficacy of infertile women after IVF failure
Public title
The effect of supportive counseling on self-esteem and self-efficacy of infertile women after IVF failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of primary infertility Negative pregnancy test following failure of the first IVf Iranian and resident of Mashhad ability to speak and write in Persian No known medical conditions do not smoke or drink alcohol Has a smartphone or any electronic device with the ability to connect to the Internet Satisfaction to participate in the study Do not have a mental illness
Exclusion criteria:
Occurrence of stressful events during the study Not attending one of the counseling sessions, participating in other training and counseling sessions while studying
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization Randomization tool: statistical software(Random allocation software) How to make a random sequence: They are selected as available and are randomly placed in each of the groups using a simple random sequence. Hide allocation: using randomly sealed opaque envelopes with random sequence
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This analysis is only performed on patients who have completed all stages of counseling correctly - generalizing the results to the community should be done with caution.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences and Health Services
Street address
Khorasan Razavi - Mashhad - University Street - in front of University Alley 18 - Mashhad University of Medical Sciences - Vice Chancellor for Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9188667656
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.010

Health conditions studied

1

Description of health condition studied
It is not a disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Infertility self-efficacy
Timepoint
At the beginning of the study and 4 weeks after the intervention
Method of measurement
Infertility self-efficacy questionnaire

2

Description
Self-esteem
Timepoint
At the beginning of the study and 4 weeks after the intervention
Method of measurement
Eysenck Self-esteem questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group": Support counseling in 4 sessions (28), two face-to-face sessions and two face-to-face sessions - virtual and each session for 45 to 60 minutes and each week with the content of the first session (individual-face-to-face): reassuring and explanation (establishing a positive relationship, resolving Patient misunderstandings and doubts and pointing out potential abilities and potentials and reducing stress by clarifying and providing information and explanation on the subject under discussion, Jacobsen relaxation training)،Second and third sessions (individual-virtual): guidance, encouragement and persuasion (online virtual individual counseling with the content of the first session feedback, explanation of various assisted reproductive methods, treatment protocols, experience of successful mothers, providing success statistics of reproductive assistive methods), fourth session (Individual-face-to-face): Vacation (practicing the techniques of revealing and discharging emotions, psychological support by active and empathetic listening, and a positive and unconditional outlook on life) is provided.
Category
Behavior

2

Description
"Control group":in the first session coordinated by the clients at the Infertility Center, the Demographic Characteristics Questionnaire, Eysenck Self-Esteem Questionnaire and Cousinio (2006) Infertility Self-Efficacy Questionnaire were completed and routine care provided at Milad Infertility Center was included. With how to continue treatment is assisted reproduction
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad Infertility Clinic Mashhad
Full name of responsible person
Dr. Fatemeh Zahra Karimi
Street address
East Razi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91359 13556
Phone
+98 51 3853 4021
Email
karimifz@mums.ac.ir
Web page address
http://www.goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hussein Bahraini
Street address
Khorasan Razavi - Mashhad - University St. - Ghorashi Building of the Presidential Building of Khorasan Razavi University of Medical Sciences and Health Services
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
shafaghim2@mums.ac.ir
Grant name
Grant code / Reference number
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
Manijeh Shafaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ibn Sina St., Ph.D. Crossroads, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Shafaghim2@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Zahra Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
University Street, Doctoral Crossroads, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Karimifz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Manijeh Shafaghi
Position
ُStudent
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
University Street, Doctoral Crossroads, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
shafaghim2@mums.ac.ir

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
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