1. Detection of depression Before intervention in both the control and experimental groups
2. Detection of depression immediately and two months after intervention in both the control and experimental groups
3. Comparison of depression before and immediately and two months after intervention in both the control and experimental groups
Design
In this research, 70 patients with infertility diagnosis referring to the Milad Infertility Center were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
Before intervention, depression of two groups of test and control are measured. then, the acupressure of the ear will be applied to the patients in the test group for one month. Depression in both groups is determined immediately after the intervention and two months later.The levels of depression in the two groups will be compared over three stages.
Participants/Inclusion and exclusion criteria
Women with a Definitive diagnosis of infertility refer to the Milad Infertility Center for treatment, and according to the Beck Questionnaire score, they have some degree of depression but have no severe depressive disorder. They tend to participate in the project and have a natural eardrum.
Intervention groups
In the test group, 35 infertile patients undergo acupressure on the ears, And in the control group there are 35 patients whose intervention is not done
Main outcome variables
Exercise Acupressure is expected to reduce depression in infertile women.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171212037842N1
Registration date:2018-01-12, 1396/10/22
Registration timing:registered_while_recruiting
Last update:2018-01-12, 1396/10/22
Update count:0
Registration date
2018-01-12, 1396/10/22
Registrant information
Name
Marjan ghodrati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 1227
Email address
ghodrati.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-15, 1396/09/24
Expected recruitment end date
2018-01-14, 1396/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Auricular Acupuncture on depression in infertile women
Public title
The effect of Auricular Acupuncture on depression in Infertility
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a definitive diagnosis of infertility
Be Iranian
No history of mental disorders associated with depression and medical illness
Non-drug and non-pharmacological treatment of depression
No severe depression
Has a natural eardrum, no lesion, wounds and pain
The desire to participate in the scheme
Exclusion criteria:
Pregnancy during the design
Choose another cure for depression
Continue to cure infertility in another city or city
Not Completing the Acupressure Course
Severe Depression Disorder
Disclaimer of continued cooperation
Age
From 19 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly divided into two equal groups using simple random sampling.
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
Ethnical Committee of Gonabad University of Medical Sciences
Street address
No. 8, Ghaem 30, Ghaem Ave
City
Torbat Heydareih
Province
Razavi Khorasan
Postal code
95441-54169
Approval date
2017-03-14, 1395/12/24
Ethics committee reference number
IR.GMU.REC.1395.130
Health conditions studied
1
Description of health condition studied
Depression in infertility
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Mean score and severity of depression
Timepoint
Detection of depression before intervention, immediately after intervention, two months after intervention
Method of measurement
Beck Depression questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group, receives Acupuncture ear on three ears of ear in for one month and twice on day.
Category
Treatment - Other
2
Description
The seconde Intervention group: Control group, does not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز ناباروری میلاد شهر مشهد
Full name of responsible person
نیره خادم
Street address
next to Sina Hospital, East Razi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
ivfcenter@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
علی محمد پور
Street address
Asian road border, Gonabad city
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3514
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Marjan Ghodrati
Position
Student of medical surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 8, Ghayem 30, Ghayem Ave
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9544154169
Phone
+98 51 5222 1227
Fax
Email
ghodrati.m@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Marjan Ghodrati
Position
Student of medical surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 8, Ghayem 30, Ghayem Ave
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9544154169
Phone
+98 51 5222 1227
Fax
Email
ghodrati.m@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Marjan Ghodrati
Position
Student of medical surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 8, Ghayem 30, Ghayem Ave
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9544154169
Phone
+98 51 5222 1227
Fax
Email
ghodrati.m@gmu.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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available