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The Effect of Peer Assisted Learning on Marital Adjustment and quality of life of infertile women

Protocol summary

Summary
This clinical trial will be carried out on 124 infertile women. After sampling, the questionnaires of life quality (short from 36 health survey) , marital adjustment (locke wallace marital adjust ment test) , and individual-social will be filled by the subjects. Then, the samples of the population with Diploma, who had achieved higher score than the mean in pre-test, will be selected as the head of peers. The researcher will train the heads for two one-hour sessions with one week interval. In first session, all the contents of the training pamphlet including: 1) way of scheduling the meetings and phone calls, 2) the meaning of marital adjustment and way of promoting it, 3) the concept of life quality and way of promoting it, 4)definition of infertility, cause and methods of diagnosing and treatment, and 5) the probability of effect of infertility on marital adjustment and life quality, will be explained and they will be required to study the training booklet by forthcoming week and ask their questions. The samples will be divided into control and intervention groups by blocking. The intervention group will be categorized into 10 groups and each peer heads will be randomly allocated to intervention groups and the heads will communicate with group members by phone call for at least 5 minutes every week for 3 months.The control group will receive the rootin care of infertility ward. After 3 months, the post-test questionnaires will be filled by the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201505056582N12
Registration date: 2015-10-29, 1394/08/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-29, 1394/08/07
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
research assistant 0f Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Peer Assisted Learning on Marital Adjustment and quality of life of infertile women
Public title
The Effect of Peer Assisted Learning on Marital Adjustment and quality of life of Infertile Women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Having Iranian nationality; Existing the time of at least 6 months and at most 10 years from infertility diagnosis and beginning of treatment; Having the ability to communicate with others; Having Diploma or higher degrees for selected peers; Having Azeri language; Having cellphone; Not having chronic diseases which have effect on life quality and marital adjustment (diabetes, blood pressure, heart diseases, …); Having inclination to participate in the study Exclusion criteria: Having physical limitations which have effect on life style (deafness, blindness, deformity, and ….); Having psychological diseases based on her statements and her file in herself or in her husband; Occurring horrible and stressful events during the study; Having stepchild or child that lives with the couples.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-06-13, 1394/03/23
Ethics committee reference number
TBZMED.REC.1394.98

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
n97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Marital Adjustment
Timepoint
before intervention and after 3 month
Method of measurement
Lock Wallace Marital Adjustment Test questionaires

2

Description
Timepoint
Method of measurement

Secondary outcomes

empty

Intervention groups

1

Description
آhead of peers: the samples of the population with Diploma, who had achieved higher score than the mean in pre-test, will be selected as the head of peers. The researcher will train the heads for two one-hour sessions with one week interval. In first session, all the contents of the training pamphlet including: 1). way of scheduling the meetings and phone calls, 2). the meaning of marital adjustment and way of promoting it, 3). the concept of life quality and way of promoting it, 4). definition of infertility, cause and methods of diagnosing and treatment, and 5). the probability of effect of infertility on marital adjustment and life quality, will be explained and they will be required to study the training booklet by forthcoming week and ask their questions. intervention groups:The intervention group will be categorized into 10 groups and each peer heads will be randomly allocated to intervention groups and the heads will communicate with group members by phone call for at least 5 minutes every week for 3 months and will answer their questions based on what trained on training sessions
Category
N/A

2

Description
Control group:The control group will receive the rootin care of infertility ward.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Zahra Joudian
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin kamalifard
Street address
Nursing and Midwifery,Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Nursing and Midwifery,Tabriz University of Medical Sciences
Full name of responsible person
Mahin kamalifard
Position
Master sciences of Midwifery
Other areas of specialty/work
Street address
Shariaty st, Nursing and Midwifery,Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 934 796 770
Fax
Email
kamalifardm@tzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mahin kamalifard
Position
Master of Sciences of Midwifery
Other areas of specialty/work
Street address
Shariaty st, Nursing & Midwifery, Tabriz University of Medical Sciences
City
tabriz
Postal code
5138947977
Phone
+98 34796770
Fax
Email
kamalifardm@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mahin kamalifard
Position
Master of Sciences of Midwifery
Other areas of specialty/work
Street address
Shariaty st, Nursing & Midwifery Faculty, Tabriz,Eastern Azarbaijan
City
،abriz
Postal code
5138947977
Phone
+98 34796770
Fax
Email
kamalifardm@tbzmed.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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