Comparing of the effectiveness of Written Emotional Disclosure and Bensons Relaxation on anxiety and perceived stress in the family members of ICU patients of Shahrekord Kashani hospital
Comparing of the effectiveness of Written Emotional Disclosure and Bensons Relaxation on anxiety and perceived stress in the family members of ICU patients of Shahrekord Kashani hospital
Design
Given that there are three ICU wards 1, 2 and 3 in the hospital for trauma patients hospitalization, these three ICU wards were randomly selected as intervention group for relaxation, emotional detection and control and sampling was done by easy sampling. Randomization in groups is done using Random Allocation software.
Settings and conduct
The study is carried out on first-degree family members of patients admitted to the ICU ward of Shahrekord Kashani Hospital. The objectives of the study are described to the participants. For each intervention group, training is provided on how to do it. The Spielberger Anxiety and Stress Questionnaires will be completed by the participants before and immediately after the intervention and one month after the end of each intervention.
Participants/Inclusion and exclusion criteria
blood family members of patients in the ICU of Shahrekord Kashani Hospital, Informed consent to participate in the study, 24 hours hospitalization, at least 18 years of age, literacy, lack of cognitive and mental disorders, no drug addiction, sedatives And alcohol, no record of sedation
Intervention groups
3 intervention group: Written Emotional Disclosure, Bensons Relaxation and control group
Main outcome variables
Spiel Berger questionnaire will be used to assess severity of anxiety; Cohen's perceived stress questionnaire used to measured stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190911044749N1
Registration date:2019-10-21, 1398/07/29
Registration timing:registered_while_recruiting
Last update:2019-10-21, 1398/07/29
Update count:0
Registration date
2019-10-21, 1398/07/29
Registrant information
Name
Nasrin Forozandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 6010
Email address
nas_for@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of the effectiveness of Written Emotional Disclosure and Bensons Relaxation on anxiety and perceived stress in the family members of ICU patients of Shahrekord Kashani hospital
Public title
the effectiveness of Written Emotional Disclosure and Bensons Relaxation on anxiety and perceived stress in the family members of ICU patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First-degree blood relatives with pationt
Reading and writing skills
no psychological disorders
Non-use of drugs, sedatives and alcohol
No record of using relaxation techniques
Exclusion criteria:
Failure to cooperate at any time of study
Companions whose patients have suffered brain death
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Three ICU sections 1, 2 and 3 were randomly selected for the patients in the relaxation, emotional detection, and control groups. Samples were selected by simple sampling and randomization in groups will be done using Random Allocation software.
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 Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Ave., Shahrekord City
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2019-06-15, 1398/03/25
Ethics committee reference number
IR.SKUMS.REC.1397.71
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
stress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders
Primary outcomes
1
Description
Mean Perceived Stress Score of Family Members of Patients
Timepoint
at baseline, immediately and one month after intervention
Method of measurement
The Cohen's perceived stress Questionnaires
2
Description
Mean Anxiety Score of Family Members of Patients
Timepoint
at baseline, immediately and one month after intervention
Method of measurement
The Spielberger Anxiety Questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bensons Relaxation
Category
Behavior
2
Description
Intervention group: Written Emotional Disclosure
Category
Behavior
3
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Kashani Hospital
Full name of responsible person
Nasrin Forozandeh
Street address
Shahrekord Kashani Hospital, Parastar Ave., Shahrekord City
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Fax
+98 38 3222 8600
Email
Kashani@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Seyyed Kamal Solati
Street address
Shahrekord University of Medical Sciences, Kashani Ave., Shahrekord City
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Fax
+98 38 3334 9506
Email
pajoohesh@skums.ac.ir
Web page address
https://skums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahrekord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Nasrin Forozandeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Rahmatiyah Town, Shahrekord City
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 6010
Fax
+98 38 3334 6714
Email
nas_for@yahoo.com
Web page address
https://nursefaculty.skums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nasrin Forozandeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Rahmatiyah Town, Shahrekord City
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 6010
Fax
+98 38 3334 6714
Email
nas_for@yahoo.com
Web page address
https://nursefaculty.skums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nasrin Forozandeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Rahmatiyah Town, Shahrekord City
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 6010
Fax
+98 38 3334 6714
Email
nas_for@yahoo.com
Web page address
https://nursefaculty.skums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Personal information will be used only in this study
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available