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Effect of family - patient communication on the incidence of delirium in hospitalized patients

Protocol summary

Summary
Objectives, This study has been done with the purpose of assessing the effect of the relationship between the family and the patient on the incidence of delirium in hospitalized patients in cardiovascular surgery ICU. Design, This study is a two groups and single-blind (for the questioner) clinical trial. Setting and conduct,Study has been conducted on 68 patients in the cardiac surgery ICU of Shahid Cchamran hospital affiliated to Isfahan University of Medical Science. Sampling was convenient sampling, and the subjects were allocated to two groups (n= 34 patients) based on random numbers table. Participants including major eligibility criteria, Inclusion criteria were age of 18-70 years, availability of immediate family members, absence of addiction to drugs, alcohol and cigarette smoking, absence of delirium, consciousness level disorder and mental diseases before surgery, absence of blindness and deafness, elective open heart surgery, no family history for surgery, and absence of intubation with a tracheal tube. In cases of patients’ or their reluctance to continue participation, death or existence of post-surgery acute complications, the patients were excluded from the study. Intervention, The day after surgery, one of the family members in intervention group who had been received the education was allowed to visit the patient in the morning shift. In the control group, subjects received routine care. Two groups were assessed for delirium ,three times, with use of RASS and CAM-ICU scale. Main outcome measures, Family - patient communication can reduce delirium.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604107391N3
Registration date: 2017-01-14, 1395/10/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-14, 1395/10/25
Registrant information
Name
Maryam Eghbali Babadi
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7539
Email address
eghbali@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2013-04-09, 1392/01/20
Expected recruitment end date
2013-08-11, 1392/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family - patient communication on the incidence of delirium in hospitalized patients
Public title
Family - patient communication on the incidence of delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Availability of immediate family members; absence of addiction to drugs, alcohol and cigarette smoking; absence of delirium, consciousness level disorder and mental diseases before surgery; absence of blindness and deafness; elective open heart surgery; no past history for surgery; absence of intubation with a tracheal tube Exclusion criteria: In cases of patients’ or their reluctance to continue participation; death or existence of post-surgery acute complications
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 68
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
Ethics Committee Of Isfahan University Of Medical Sciences
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran.
City
Isfahan
Postal code
009881746-73461
Approval date
2013-04-09, 1392/01/20
Ethics committee reference number
ir.mui.rec.1392.3.010

Health conditions studied

1

Description of health condition studied
Delirium
ICD-10 code
F05.9
ICD-10 code description
Delirium, unspecified

Primary outcomes

1

Description
Delirium
Timepoint
Three times (before intervention, and twice in the morning and evening after the intervention)
Method of measurement
RASS and CAM-ICU scale

Secondary outcomes

1

Description
Demographic data of Patients and family member
Timepoint
Once before the intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: Researcher held a two- hour class for the families to familiarize them with the goal, signs, causes, prevention methods of delirium and communicational methods and distributed pamphlets among them. These materials were reviewed before each visit with the family members. To administrate the intervention, from the day after surgery, when the patient was separated from ventilation device and was able to communicate, after making coordination with ICU staff and at a certain time of morning shift (once a day), a family member in study group(selected by the patient and undergone necessary education) was permitted to attend by the patient for 30-40 minutes and communicated with him/ her, based on the already received education after wearing a disposable gown, shoes cover, a mask and disinfection of the hands with an anti- bacterial spray.
Category
Prevention

2

Description
Control group:For the patients in control group, no special visit was scheduled and the family visited their patients based on hospital regulations although their visits were recorded.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Maryam Eghbali Babadi
Street address
Shahid Chamran Hospital , Bridge Bozorgmehr, Third Moshtagh, Isfahan, Iran.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research,Isfahan University Of Medical Sciences
Full name of responsible person
Dr Payman Adibi
Street address
Isfahan University O Medical Science, Hezar Jerib Avenue, Isfahan, Iran.
City
Isfahan
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,Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
Maryam Eghbali Babadi
Position
Faculty Member
Other areas of specialty/work
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3792 2940
Fax
Email
eghbali@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Maryam Eghbali Babadi
Position
Faculty Member
Other areas of specialty/work
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3792 2940
Fax
Email
eghbali@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan Univercity Of Medical Science
Full name of responsible person
Maryam Eghbali Babadi
Position
Faculty Member
Other areas of specialty/work
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3673 5885
Fax
Email
eghbali@nm.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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