The impact of family-centered interventions on family anxiety and depression and self-efficacy in patients with loss of consciousness in intensive care units
Determine of impact of family-centered interventions on family anxiety and depression and self-efficacy in patients with loss of consciousness in intensive care units
Design
Clinical trial, with a randomized stratified sampling
Settings and conduct
This study is a clinical trial study performing in ICU wards in Ashayer and Shahid Rahimi Hospital in Khorramabad city.
In this study, samples of caregivers of patients with loss of consciousness were selected using convenience sampling and divided into two groups of control and intervention.
Prior to the study, both anxiety and depression questionnaires were completed by caregivers in both control and intervention groups.
In the intervention group, caregivers received 3 sessions of required training based on the traning booklet prepared by the researcher. After the intervention, both questionnaires were completed again by the intervention group.
In the control group, both questionnaires were completed before the study and after completing the study, they completed the questionnaire again.
At the end of the study, in order to ethical considerations, the training booklet, was descriptively trained to caregivers
Participants/Inclusion and exclusion criteria
Inclusion criteria: caregivers of patients with loss of consciousness which were hospitalized in ICU ward who tend to participate in research.
The exclusion criteria include caregivers who are unwilling to cooperate in the study and cannot take care of their patients.
Intervention groups
Intervention group; Family caregivers of patients with loss consciousness that will received planned education to take care of their patients.
Control group; Family caregivers of patients with loss consciousness that will received routine services to take care of their patients.
Main outcome variables
Anxiety- Depression and self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180721040540N2
Registration date:2019-11-15, 1398/08/24
Registration timing:registered_while_recruiting
Last update:2019-11-15, 1398/08/24
Update count:0
Registration date
2019-11-15, 1398/08/24
Registrant information
Name
Heshmatolah Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0160
Email address
heidari.h@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of family-centered interventions on family anxiety and depression and self-efficacy in patients with loss of consciousness in intensive care units
Public title
The impact of family-centered interventions on family anxiety and depression and self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Caregivers with patients with loss of consciousness in intensive care units.
Willingness to participate in the study
Literate for reading and writing
Caregivers that among family members accept responsibility of caring of their patients directly.
Prediction of hospitalization of patient in the intensive care unit for at least two weeks
Exclusion criteria:
Caregivers who have an academic education in the field of health (physician, nurse or ...).
Caregivers who have the previous experience of caring for patients with loss of consciousness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling was convenience sampling method. Eligible subjects with using the Random stratified blocks method located in the intervention or control groups. (Stratified in order to gender equality in the both groups). Considering the gender as stratified, in the inside this stratifies, subjects as blocks 4-6 will located in the intervention or control groups randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Subjects wouldn't inform of their situation in group of intervention or control to end of study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Kelometr 5 Kamalvand Khoramabad- Boroujerd Road, Lorestan University Of Medical Sciences
City
Korramabad
Province
Lorestan
Postal code
68149-93165
Approval date
2018-07-28, 1397/05/06
Ethics committee reference number
IR.LUMS.REC.1397.196
Health conditions studied
1
Description of health condition studied
Anxiety, Depression and Self- Efficacy of low conscious of caregivers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety, Depression and Self- Efficacy
Timepoint
Before and 2 week after study
Method of measurement
Questionnaire of Hospital Anxiety and Depression Scale, & Researcher-made questionnaire of Self-efficacy
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group; in the intervention group, educations conducted in the tree steps. First step: Theoretical education about necessity of caring of loss conscious patients, management of nutrition, caring of skin, change position, prevention of bedsore, suction of secretions and …, Second step: Caregivers will presence in the clinical of patients and educated by researcher as practical in three days a week. Also educational brochure and pamphlet about the methods of caring of patients will be provided for caregivers.Three step: Caregivers will presence in the clinical of patients in corporation of researcher (nurse) and give caring to patients as practical.
Category
Other
2
Description
Control group: the control group will be received usual care of the hospital by the end of the study. Of course, after the study the subjects in the control group will also benefit from the training provided for the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Lorestan University of Medical Sciences
Full name of responsible person
Heshmatolah Heydari
Street address
Kilometr 5 Khorramabad- Boroujerd Road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Heidari.H@Lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatolah Heydari
Street address
Kiloumetr 5 Khorramabad- Boroujerd Road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Heidari.H@Lums.Ac.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatolah Heydari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kilomer 5 Khorramabad- Broujerd Road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Heidari.H@Lums.ac.Ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatolah Heydari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kilometr 5 Kho- Broujer Road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Hiedari.H@Lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatolah Heydari
Position
Faculty Member- Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kiloumetr 5 Tehran- Broujerd road
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0157
Fax
+98 66 3312 0140
Email
hidari74@gmail.com
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
Because of security
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
To Transparency of data
When the data will become available and for how long
In the 5 years period
To whom data/document is available
Authors of study- Dear of research- Supervisors of study and editor of journals
Under which criteria data/document could be used
To Transparency process of study
From where data/document is obtainable
Corresponding of study
What processes are involved for a request to access data/document