The effect of counseling intervention by a midwife on perceived infertility-related stress and outcome of assisted reproductive technology in infertile women
This study is an interventional study. Our population is infertile women referred to Imam Khomeini hospital and the mother clinic in Sari. The sample size identified after the pilot study and selected randomly, then they will be assigned randomly into two groups. The tools used in this study is, a questionnaire on demographic characteristics, general health questionnaire and Newton infertility stress questionnaire. Intervention program will be led by trained midwifery counseling and supervised graduate student research team . The intervention consisted of six two-hour sessions of group counseling services. The control group received only usual care of center. Finally, the data for statistical analysis will be entered into statistical software software SPSS (version 21).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080328528N2
Registration date:2016-08-24, 1395/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-24, 1395/06/03
Registrant information
Name
Zeinab Hamzehgardeshi
Name of organization / entity
Mazandaran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.hamzehgardeshi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-08-20, 1395/05/30
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling intervention by a midwife on perceived infertility-related stress and outcome of assisted reproductive technology in infertile women
Public title
Effect of group counseling on stress reduction in infertile women undergoing assisted reproductive techniques
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: women less than 45 years, primary infertility, women treated with IVF and ICSI, Iranian nationals, having read and write ability, do not intend to use the embryo and oocyte donation or a rented uterus, don't having adopted child, not being under consulting psychologist or psychiatrist during the study or at least one month before the start of the study, no major psychiatric disorder during the study period (detect the first visit by a psychiatrist) and non-use of psychiatric drugs, the lack of intense domestic debate in the weeks leading up the beginning of the study, the lack of cigarettes, hookah and drink alcohol, lack of systemic diseases such as diabetes, hypertension, hyperlipidemia and diseases of the thyroid gland, based on treatment history, records and reports of the person in study, dont receiving ovulation induction treatment in other centers.
Exclusion criteria included: lack of ovarian response to stimulation drugs, stops ovulation induction treatment, IVF program is canceled for any reason under medical supervision, the occurrence of bitter contention family, death of a relative or a traumatic event during treatment, the diagnosis pregnancy by blood tests during the study, received or necessity of prescribing any medication or psychotherapy counseling during the study.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
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
Ethics committee of Mazandaran University of Medical science
Street address
Moalem square, Vice chancellor for research
City
Sari
Postal code
4843163181
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
IR.MAZUMS.REC.95.2316
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
inability to achieve a pregnancy
Primary outcomes
1
Description
Perceived Stress related to infertility
Timepoint
Before the intervention, After the intervention, puncture day, day of embryo transfer, a pregnancy test day
Method of measurement
Newton Infertility Stress Questionnaire
Secondary outcomes
1
Description
The outcome of assisted reproduction treatment
Timepoint
Two weeks after embryo transfer
Method of measurement
Beta-HCG measurement by blood tests
2
Description
The number of oocytes obtained
Timepoint
Puncture Day
Method of measurement
Counting oocytes by embryologists
3
Description
The fertilization rate
Timepoint
Puncture Day
Method of measurement
View by embryologists
Intervention groups
1
Description
The intervention consisted of six two-hour sessions of group counseling services.The first half hour the support group and continuation psychological training that focuses on stress management in infertility women. In summary the content of the sessions: the first session learning about infertility and its causes and impact of stress on the outcome of pregnancy rate, body relaxation training, the second session includes improved control of emotions and head and face relaxation training, the third meeting included of the Communication Skills Training , the fourth session, coping skills training,the fifth session is stress management training and the sixth meeting is improving knowledge in relation to other aspects of treatment (pregnancy by a third partner).
Category
Treatment - Other
2
Description
Control group will receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mother Infertility clinics
Full name of responsible person
Dr. Zeinab HamzehGardesi
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street
City
Sari
2
Recruitment center
Name of recruitment center
Infertility Center of Imam Khomeini Hospital
Full name of responsible person
Dr. Zeinab HamzehGardesi
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahmadali_enayati@yahoo.com
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Moalem Street, Vice chancellor for research
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahmadali_enayati@yahoo.com
Proportion provided by this source
100
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Zeinab Hamzehgardeshi
Position
Phd
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Street, Amir Mazandarani Street
City
Sari
Postal code
48431-63181
Phone
+98 11 3336 7342
Fax
+98 11 3337 8915
Email
z.hamzehgardeshi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Zeinab Hamzehgardeshi
Position
Phd
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Street, Amir Mazandarani Street
City
Sari
Postal code
48431-63181
Phone
+98 11 3336 7342
Fax
+98 11 3337 8915
Email
z. hamzehgardeshi@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Zeinab Hamzehgardeshi
Position
Phd
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street
City
Sari
Postal code
48431-63181
Phone
+98 11 3336 7342
Fax
+98 11 3337 8915
Email
z. hamzehgardeshi@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)