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The effectiveness survey of holistic-oriented psychological intervention on stress of infertility, quality of life, psychological health, marital adjustment and rate of infertility in infertile women undergoing ART in Kermanshah

Protocol summary

Summary
The purpose of this study is to determine of the effectiveness of holistic-oriented psychological intervention on stress of infertility, quality of life, psychological health, marital adjustment and rate of fertility in infertile women undergoing ART in Kermanshah. This study is a semi-experimental study with two groups; intervention (n=60) and control (n=60). The study population is infertile women referred to Kermanshah Motazedi hospital and the sample size is 120 women. Inclusion criteria are; age between 20-45 years and moderate to severe depression or stress score in DASS-21 scale. Exclusion criteria are; no responding ovaries to treatment and have secondary infertility. Experimental group receive holistic- oriented psychological intervention in 10 sessions (2 hours in week). Control group receive no kind of intervention. Primary outcomes are; increase quality of life and psychological health in infertile women.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015061322680N1
Registration date: 2015-08-13, 1394/05/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-13, 1394/05/22
Registrant information
Name
Monir Hossinie
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3883 5456
Email address
m-hossini@phdstu.scu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Science
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness survey of holistic-oriented psychological intervention on stress of infertility, quality of life, psychological health, marital adjustment and rate of infertility in infertile women undergoing ART in Kermanshah
Public title
The effectiveness survey of holistic-oriented psychological intervention on stress of infertility, quality of life, psychological health, marital adjustment and rate of infertility in infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: at least guidance school educated; age between 20-45 years; primary infertility; not have somatic and psychiatric diseases; using the ART (IVF, ICSI) treatment; moderate to severe depression or stress scores in DASS-21 scale. Exclusion criteria: no responding ovaries to treatment; somatic or psychiatric problems; have secondary infertility.
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: 120
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
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd
City
Kermanshah
Postal code
Approval date
2015-05-31, 1394/03/10
Ethics committee reference number
KUMS.REC.1394.20

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
infertility stress
Timepoint
Before-after and one month after intervention
Method of measurement
inFertility problem inventory(FPI)

2

Description
quality of life
Timepoint
befor- after and a month after intervention
Method of measurement
quality of life questionnaire Fertiqol

3

Description
Dyadic adjustment
Timepoint
Before-after and one month after intervention
Method of measurement
Dyadic adjustment scale (DAS)

Secondary outcomes

1

Description
pragnancy rate
Timepoint
Two weeks after embryo transfer
Method of measurement
BHCG test

Intervention groups

1

Description
intervention group:Holistic-oriented Psychological intervention, duration: 10 sessions. any session 2 hours. skills training; stress management, effective communication couples, controlling anger, mindfulness
Category
Behavior

2

Description
control group: receive no kind of treatments
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah Infertility Treatment center, Motazedi Hospital
Full name of responsible person
Dr. Nasrin Jalilian
Street address
Kermanshah Infertility Treatment centre, Motazedi Hospital, Ferdosi Square, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Dr. Reza Khodarahmie
Street address
Shahid Beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Science
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
Kermanshah University of Medical Sciences
Full name of responsible person
Monir Hossinie
Position
PhD Student
Other areas of specialty/work
Street address
Farabi Educational hospital, Dowlat Abad st., Isar square
City
kermanshah
Postal code
Phone
+98 83 3826 0700
Fax
Email
m-hossini@phdstu.scu.ac.air
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Monir Hossinie
Position
PHD student
Other areas of specialty/work
Street address
Farabi Educational Hospital, Dowlat Abad st., Isar Square
City
Kermanshah
Postal code
Phone
+98 83 3826 0700
Fax
Email
m-hossini@phdstu.scu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Monir Hossinie
Position
PhD Student
Other areas of specialty/work
Street address
Farabi Educational Hospital, Dowlat Abad st., Isar Square
City
Kermanshah
Postal code
Phone
+98 83 1826 0700
Fax
+98 83 3826 4163
Email
m-hossini@phdstu.scu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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