The effect of psychological empowerment on using coping mechanisms, stress, anxiety and depression in hemophiliac adolescents in comparison without taking it
The aim the present study is to examine the effects of psychological empowerment on the use of coping strategies, stress, anxiety and depression in adolescents with hemophilia. Participants are 60 adolescents with hemophilia who referred to Dastgheyb Hospital. They will divide to intervention and control groups using block randomization method. Main inclusion criterion is having 13 to 19 years old and main exclusion criterion is more than one day absence from intervention sessions. Participants do not aware of their group. Eight psychological empowerment sessions forecast for intervention group, will be two sessions per week and each session takes about an hour and a half. Coping strategies used by patients will be compared before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502079267N4
Registration date:2015-07-25, 1394/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-25, 1394/05/03
Registrant information
Name
Giti Setoodeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
setoodeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psychological empowerment on using coping mechanisms, stress, anxiety and depression in hemophiliac adolescents in comparison without taking it
Public title
The effect of psychological empowerment on psychological outcome in hemophiliac adolescents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- ages between 13 and 19 years old; 2- no obvious physical or mental disability; 3- being interested for participation in the research.
Exclusion criteria: 1- absence in the case of more than one session; 2- withdraw from further cooperation at every stage of the research; 3- the experience of bereavement or other adverse conditions during psychological intervention
Age
From 13 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University of Medical Sciences
Street address
Zand Street, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
CT-9374-7364
Health conditions studied
1
Description of health condition studied
hemophilia
ICD-10 code
D66,D67
ICD-10 code description
Hereditary factor VIII deficiency; Hereditary factor IX deficiency
Primary outcomes
1
Description
Coping mechanisms
Timepoint
Immediately and one month after the intervention
Method of measurement
Lazarus Questionnaire
Secondary outcomes
1
Description
Anxiety, stress and depression
Timepoint
Immediately and one month after the intervention
Method of measurement
DOSS- 21 Questionnaire
Intervention groups
1
Description
Intervention group will attend in 8 sessions of psychological empowerment. Psychological empowerment interventions are a group of interventions, including awareness among the patients about the nature of the disease, hemophilia and its symptoms, strategies for problem-solving skills and strategies to reduce stress, depression and anxiety.
Category
Rehabilitation
2
Description
Control group does not receive any intervention but they are monitored for comparing with the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dastgheib Hospital
Full name of responsible person
Azam Karami
Street address
Quran Street, Ebnesina Psychiatry Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Zand Street, Shiraz University of Medical Sciences
City
Fars
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Position
Vice chancellor for research, Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Zand Street, Shiraz University of Medical Sciences.
City
Shiraz
Postal code
Phone
+98 71 3235 7282
Fax
Email
hashemib@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Giti Setoodeh
Position
Master of Science, Faculty member
Other areas of specialty/work
Street address
Room 57, third floor, Fatemeh School of Nursing and Midwifery, Namazi Square, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
setoodeh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azam Karami
Position
Nursing Post- graduate student
Other areas of specialty/work
Street address
Room 57, third floor, Fatemeh School of Nursing and Midwifery, Namazi Square, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 61 5272 5309
Fax
Email
azam.k1367@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)