The effect of informing family members on anxiety and depression and their satisfaction
Design
A randomized clinical trial with control group, single blind, two groups with design before and after the intervention. The sample size was calculated by using a guideline and a 30-person depression variable in each group..
Settings and conduct
The research environment is the ICU in Sagadieh Torbat Jam Hospital and the selection of research units are among the family of patients admitted to the intensive care unit. The research units were randomly assigned to two intervention groups (nursing report at the end of each shift) and control group (common education).The researcher randomly divided the families into two groups (test and control). In both groups at the beginning of the admission of the patient in the ICU and 48 hours later, the anxiety and depression and family satisfaction status was measured using the HADS and FS-ICU questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age less than 60 years old. Lack of chronic diseases. Patients' admission must take place within 48 hours and they must be visited within the first 48 hours.
Exclusion criteria: Non-cooperating with the researcher
Intervention groups
In the intervention group, selecting two relatives of the patient, teaching nurses about writing a report in plain language, presenting the report to the spokespersons and transferring information to the family, at the end of each shifts (six times) during the initial 48 hours.
In the control group, the information will be provided routinely and to all family members.
The effect of nurses programmed report to family of patients admitted to intensive care units On their anxiety, depression, and satisfaction of care
Public title
Impact of information on anxiety and depression and satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
They are less than 60 years old.
The cause of the patient's admission is not chronic illness
At least 48 hours have passed since the patient admitted to the ICU
Having a companion for the first 48 hours
Exclusion criteria:
Not cooperating with the researcher
Age
From 1 year old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the inclusion criteria in the study, the families of hospitalized patients in the intensive care unit were randomly assigned to the intervention group using the spss software (provided reporting + previous routine) or the control group (only providing previous routine measures). In this way, 12 time intervals of a week are included in the software. Randomly the spss software specifies that each week the families of patients in the hospital are placed in the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study were assigned to two groups. In order to prevent the cross effects of the test and control group on each other, sampling was done at different time periods. Blinding was made so that there would be no communications among the group members. The questionnaires has been specified with code A (intervention group) and with code B (control group). After completing by the units involved , it is collected by the researcher. Later the results were sent to be analyzed by an statistical analyst who had no information about either groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethics Committee in Mashhad University of Medical Sciences
Street address
NO.17 university. Crossroad of the Ph.D. University Street.Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91778 -99191
Approval date
2018-02-21, 1396/12/02
Ethics committee reference number
IR.MUMS.REC 1396.408
Health conditions studied
1
Description of health condition studied
The level of anxiety
ICD-10 code
ICD-10 code description
2
Description of health condition studied
The level of Depression
ICD-10 code
ICD-10 code description
3
Description of health condition studied
level of Satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression score in hospital anxiety and depression scale(hads)
Timepoint
At the admission of the patient in the intensive care unit and 48 hours later
Method of measurement
Hospital Anxiety and Depression Scale(hads)
2
Description
Anxiety score in hospital anxiety and depression scale(hads)
Timepoint
At the admission of the patient in the intensive care unit and 48 hours later
Method of measurement
Hospital Anxiety and Depression Scale(hads)
3
Description
Satisfaction Score in family Satisfaction- Intensive Care Units(fs-icu)
Timepoint
At the admission of the patient in the intensive care unit and 48 hours later
Method of measurement
family Satisfaction Intensive Care Units(fs-icu)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group after informing patient's physician , the nurse carries out the patient's clinical situation in plain and written form at the end of the shift (6 shifts) and within 48 hours of the initial admission to intensive care unit, Then the nurse provide the spokesman with the information and answer their questions clearly (maximally 10-15 minutes). Anxiety and depression status and satisfaction of family members (spokespersons) with Hospital anxiety and depression questionnaire and family satisfaction questionnaire are checked in the care unit at the start of admission to the care unit and 48 hours later
Category
Treatment - Other
2
Description
Control group: the patient's families are orally provided with the information according to the routine of the ward (in person or after phone calls). The status of anxiety and depression and family satisfaction are checked (two of the immediate relatives of the patient are asked ) with the Hospital's anxiety and depression questionnaire of the patients admitted to intensive care unit at the beginning of the entrance to the intensive care unit and and 48 hours later.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Sajjadiyeh Torbat Jam
Full name of responsible person
Dr. Hooman Mohammadzadeh
Street address
Beginning of Torbat Jam Road to Mashhad
City
Torbat jam
Province
Razavi Khorasan
Postal code
9576175544
Phone
+98 51 5252 1811
Fax
Email
labafm941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology, Mashhad University of Medical Sciences, University St
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Fax
+98 51 3882 3251
Email
tafaghodim@mums.ac.ir
Grant name
reaserch of univercity
Grant code / Reference number
961361
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Labaf
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
no 11.Imam Khomeini -.Imam Khomeini st
City
Torbat jam
Province
Razavi Khorasan
Postal code
9571944555
Phone
+98 51 5252 9574
Email
labafm941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Labaf
Position
Senior internship in the last semester
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Doctora cross road, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9573114415
Phone
+98 51 3859 1511
Email
labafm941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Labaf
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
no 11.Imam Khomeini -.Imam Khomeini st
City
Torbat Jam
Province
Razavi Khorasan
Postal code
9571944555
Phone
+98 51 5252 9574
Email
labafm941@mums.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