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The effect of intervention based on constructive relationship between couples on the sense of spouse support in women with uterine and cervical cancer

Protocol summary

Study aim
Determining the effect of intervention based on constructive relationship between couples on the sense of spouse support in women with uterine and cervical cancer
Design
Clinical trial with control and intervention group, with parallel groups, non-blinded, randomized, on 60 patients. An envelope containing even and odd numbers was used for randomization. Even numbers are for the control group and odd numbers are for the intervention group.
Settings and conduct
Consulting room of Imam Khomeini Hospital in Urmia, Consulting room of Hospital in Urmia. There is no blinding in the study.
Participants/Inclusion and exclusion criteria
Age range of 30-60, being married, familiarity with Persian and Azerbaijani languages, diagnosis of uterine and cervical cancer, after more than 48 hours of chemotherapy, not having other cancers, under treatment of uterine and cervical cancer, stage I, II, III of uterine and cervical cancer according to pathobiology sheet, not experiencing any other stressful situations in the last 6 months, not attending other educational sessions, not having any depression history or hospitalization. The exclusion criteria include: having other cancers ، having any life-threatening illness
Intervention groups
Intervention group: Intervention Based on Couples Constructive Communication will be done on couples in intervention group, which will include groups of 6 to 10 The designed interventions include: strengthen effective and constructive discussion skills, how to manage communication problems,repairing relationships.To evaluate the participants, a diary will be provided for each person to record her daily behavior. Control group:The control group will not receive the any intervention. But due to ethical norms that they were in the control group, after the intervention, one or two sessions will do for them
Main outcome variables
Spouse support sense

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150125020778N22
Registration date: 2021-02-19, 1399/12/01
Registration timing: retrospective

Last update: 2021-02-19, 1399/12/01
Update count: 0
Registration date
2021-02-19, 1399/12/01
Registrant information
Name
Fatemeh Moghaddam Tabrizi
Name of organization / entity
Uromia University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4964
Email address
moghaddam.f@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-30, 1398/02/10
Expected recruitment end date
2020-02-21, 1398/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention based on constructive relationship between couples on the sense of spouse support in women with uterine and cervical cancer
Public title
The effect of intervention on couples on the sense of support of the spouse
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 30-60 Being married Familiarity with Persian and Azerbaijani languages Diagnosis of uterine and cervical cancer After more than 48 hours of chemotherapy Not having other cancers Under treatment of uterine and cervical cancer (chemotherapy, radiotherapy, hormone therapy) Stage I, II, III of uterine and cervical cancer according to pathobiology sheet
Exclusion criteria:
Having any life-threatening illness: Life-threatening illness are chronic, usually incurable diseases, which have the effect of considerably limiting a person's life expectancy. These include, cancer, diabetes, neurological conditions, coronary heart disease and HIV/Aids. Having other cancers
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
By taking into account the inclusion criteria and getting consent, 60 couples enter the study by availability sampling method. Using the envelope of odd and even numbers, 30 people will be selected randomly for the control group and 30 for the intervention group. 40 envelopes contain even and odd numbers from 1 to 40. Couples were asked to choose an envelope.Even numbers are for the control group and odd numbers are for the intervention group.
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 Urmia University of Medical science
Street address
Resalat blv,next to the emergency center,Urmia University of Medical sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-04-24, 1398/02/04
Ethics committee reference number
IR.UMSU.REC.1398.031

Health conditions studied

1

Description of health condition studied
uterine and cervical cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Spouse support sense
Timepoint
Before intervention and 6 weeks after the first session
Method of measurement
Spouse support questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, the intervention based on constructive relationship of couples will be done, classes will be held in groups of 6 to 10. Each session will be 60-90 minutes long per week, in 5 weeks.Sessions include: introduction, the stage of strengthening effective and constructive discussion skills and how to manage communication problems, the stage of repairing relationships, the stage of control, the stage of evaluation.
Category
Lifestyle

2

Description
Control group:The control group will not receive the any intervention. But due to ethical norms that they were in the control group, after the intervention, one or two sessions will do for them
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr .Fatemeh Moghaddam Tabrizi
Street address
Ershad street - Ayatollah Modarrers blvd , Khomeini
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 9538 3345
Fax
+98 44 9935 3346
Email
fmtabrizi@gmail.com
Web page address
http://www.umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Iraj Mohebbi
Street address
Resalat blv,next to the emergency center,Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
Irajmohebbi@umsu.ac.ir
Web page address
http://umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Urmia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr .Fatemeh Moghaddam Tabrizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Department , Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 5493 3327
Fax
+98 44 5493 3327
Email
fmyabrizi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr .Fatemeh Moghaddam Tabrizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Department , Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 5493 3327
Email
fmtabrizi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr .Fatemeh Moghaddam Tabrizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Department , Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
0098 44 5493332744
Email
fmtabrizi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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
Title and more details about the data/document
not decided yet - its publication plan is still unclear
When the data will become available and for how long
not decided yet - its publication plan is still unclear
To whom data/document is available
not decided yet - its publication plan is still unclear
Under which criteria data/document could be used
not decided yet - its publication plan is still unclear
From where data/document is obtainable
Not decided yet -itspublication plan is still unclear
What processes are involved for a request to access data/document
not decided yet - its publication plan is still unclear
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