(1) Objectives: Study on the Effect of stress management consulting on the sexual Function in women suffering from breast cancer (2) Design: The study in women with women with breast cancer referred to Mahdieh MRI Center Hamadan, with a sample content of 104, randomized, clinical trial, single-center (3)How do: patients with breast cancer referring to the MRI center of Hamadan, after obtaining informed consent, 104 cases who met the inclusion criteria were selected as convenience sampling. Using permutation blocks, they were randomly divided into two experimental and control groups (n= 52). The experimental group Participation 4 sixty-minute sessions over consecutive weeks in stress management training classes of 12 persons. The control group received no psychological intervention and only received medical treatments. Before starting therapy, test and control groups were tested by a questionnaire and two groups were post-tested after completion of sessions and two weeks later in order to follow up. The therapist specified some assignments each session to be done during the interval of the sessions by the patients. (4) Inclusion criteria: age range of 20-45 years; married; women with breast cancer of grade 3 and below after mastectomy surgery and under chemotherapy; lack of other chronic illnesses; and having passed at least one month of operating period. Exclusion criteria: included a history of important mental and physical illness such as psychosis including schizophrenia and severe depression and so on which required special medicine or diet; not participating in more than one educational session; the occurrence of stressful events(death of close relatives/friends, divorce, and drug abuse. (5) interventions: Participation 4 sixty-minute sessions over consecutive weeks in stress management training classes for experimental group and in control group not intervention. (6) The main outcome: Improve sexual function
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030623350N2
Registration date:2016-04-08, 1395/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Arezoo Shayan
Name of organization / entity
Hamadan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0551
Email address
a.shayan@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Hamadan University of Medical Sciences
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the Effect of stress management consulting on the sexual Function in women suffering from breast cancer
Public title
The impact of stress management consulting on sexual function and stress in women with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age range of 20-45 years; married; women with breast cancer of grade 3 and below after mastectomy surgery and under chemotherapy; lack of other chronic illnesses; and having passed at least one month of operating period. Exclusion criteria: included a history of important mental and physical illness such as psychosis including schizophrenia and severe depression and so on which required special medicine or diet; not participating in more than one educational session; the occurrence of stressful events (death of close relatives/friends, divorce), and drug abuse.
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:
104
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
Ethics committee of Hamadan University of Medical Sciences
Street address
Front of Mardom park, Shahid Fahmideh Street, Hamadan University Of Medical Sciences, Hamadan
City
Hamadan
Postal code
-
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
IR.UMSHA.REC.1394.497
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.1, C50
ICD-10 code description
Central portion of breast, Upper-inner quadrant of breast, Lower-inner quadrant of breast, Upper-outer quadrant of breast, Lower-outer quadrant of breast, Axillary tail of breast, Overlapping lesion of breast, Breast, unspecifie
Primary outcomes
1
Description
sexual function
Timepoint
Before,2 weeks after intervention
Method of measurement
Sexual function questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:stress management consulting
4 sessions in 60 minutes, for 4 weeks
Category
Behavior
2
Description
In intervention group2: Without intervention
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
MRI Center Hamadan
Full name of responsible person
Vahid Tahmasebi
Street address
Nurse Street, MRI Center Mahdiyeh, Hamadan.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Yosef Alikhani
Street address
Front of Mardom park, Shahid Fahmideh Street, Hamadan University Of Medical Sciences, Hamadan
City
Hamadan
Grant name
-
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Hamadan 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
Hamadan University Of Medical Science
Full name of responsible person
Arezoo Shayan
Position
Masters, Lecturer Faculty
Other areas of specialty/work
Street address
Front of Mardom park, Shahid Fahmideh Street, Hamadan University Of Medical Sciences, Hamadan
City
Hamadan
Postal code
-
Phone
+98 81 3838 0551
Fax
-
Email
arezoo.shayan2012@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University Of Medical Science
Full name of responsible person
Arezoo Shayan
Position
Masters, Lecturer Faculty
Other areas of specialty/work
Street address
Front of Mardom park, Shahid Fahmideh Street, Hamadan University Of Medical Sciences, Hamadan
City
Hamadan
Postal code
-
Phone
+98 81 3838 0551
Fax
-
Email
arezoo.shayan2012@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University Of Medical Science
Full name of responsible person
Arezoo Shayan
Position
Master degree, Lecturer faculty
Other areas of specialty/work
Street address
Front of Mardom park, Shahid Fahmideh Street, Hamadan University Of Medical Sciences, Hamadan
City
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0551
Fax
Email
arezoo.shayan2012@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)