Main objective of the study is The impact of educational support programe on anxiety and stress of women suffer from endometrial cancer. This study is a randomized control trial. Inclusion criteria include patients with endometrial cancer(histopathologic report),below 65 years old and literated, no known mental disease and disability and refractory chronic diseases,history of using antidepressant and relaxant agents. Exclusion criterias are: taking antidepressant and relaxant agents during 2 first weeks of interventionand and accurance of stressful events during study.140 patients using randomized form are divided into intervention and control groups.Thus,70 cases are in each group. Intervention includes 3 sesession in 3 weeks. Every sessen lasts 40-60 minutes. control group will receive routines care. Just after third session, 1 and 2 months later,questionnaires will filled again by patients.In this study we use 3 questionnaires:demographic,Harri`s stress and bek`s enxiety.At the end, anxiety and stress will compared between control group and intensive group. In this study,the main outcomes variable are anxiety and stress.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120515668N1
Registration date:2014-02-03, 1392/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-03, 1392/11/14
Registrant information
Name
Soudabeh Niroomand
Name of organization / entity
Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 21 4444 4955
Email address
s.niroomand.1984@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of educational support programe on anxiety and stress of women suffer from endometrial cancer
Public title
The impact of educational support programe on anxiety and stress of women suffer from endometrial cancer
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:age below 65 years old;literate;Have an endometrial malignancies histopathologic report; no known mental disease and disability and refractory chronic diseases ;no taking antidepressant and relaxant agents ;any stressful events since 3 month ago; All of treatment of cancer must be done in study settings exclusion criteria: taking antidepressant and relaxant agents during 2 first weeks of intervention;accurance of stressful events during study
Age
From 15 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
ethic reserch of Tehran medical sciences university
Street address
Tehran keshavarz bulv at the croner of ghods st.
City
Tehran
Postal code
1419733171
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
1142 /130/ص/ 92
Health conditions studied
1
Description of health condition studied
steress and anxiety and endometrial cancer
ICD-10 code
C54.1, F41
ICD-10 code description
endometrium,generalized anxiety disorder, other reactions to sever stress
Primary outcomes
1
Description
stress
Timepoint
before.immediatly.after 1 and 2 months after intervension
Method of measurement
selfreporting by Harri`s stress
2
Description
anxiety
Timepoint
before Intervention, just after Intervention, 1 month and 2 month after Intervention
Method of measurement
selfreporting by Bek`s anxiety questionnaire
Secondary outcomes
1
Description
need to take antidepresant agents after 2 weeks of intervention
Timepoint
2 weaks
Method of measurement
selfreport
2
Description
need to take relaxant agents after 2 weeks of intervention
Timepoint
2 weaks
Method of measurement
selfreport
Intervention groups
1
Description
Intervention includes 3 sesession in 3 weeks. Every sessen lasts 40-60 minutes. Before,just after third session, 1 and 2 months later questionnaires will filled by patients
Category
Other
2
Description
Control group will receive routines care. Before,just after third session, 1 and 2 months later questionnaires will filled by patients.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Complex hospital center of Emam Khomeini
Full name of responsible person
Soudabeh Niroomand
Street address
Tohid square, school of nursing and midwifery,Tehran,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences/school of nursing and midwifery
Full name of responsible person
Tehran University of Medical Sciences/school of nursing and midwifery
Street address
Tohid square,School of nursing and midwifery,Tehran,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences/school of nursing and midwifery
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
School of nursing and midwifery
Full name of responsible person
Leila Neisani Samani
Position
MS/faculty of university
Other areas of specialty/work
Street address
Tohid square,School of nursing and midwifery,Tehran,Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
eneisani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of nuring and midwifery
Full name of responsible person
Leila Neisani Samani
Position
faculty of university
Other areas of specialty/work
Street address
Tohid square,School of nuring and midwifery , Tehran,Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
eneisani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of nursing and midwifery
Full name of responsible person
Soudabeh Niroomand
Position
Ms student
Other areas of specialty/work
Street address
Tohid square,school of nursing and midwifery, Tehran,Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
s.niroomand.1984@gmail.comsnmw90@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)