The purpose of this study is to examine the effect of a family-focused intervention on anxiety and satisfaction of family members of the intensive care unit patients. Inclusion criteria would be being the patient's husband, wife, brother, sister, father, mother or closest person in the family; being present at hospital in the first 24 to 48 hours of admission; and being emotionally prepared for taking part in the study. Exclusion criteria would be giving up for continuing participation in the study and patient death. The population under study is the first degree relatives of the patient admitted to intensive care unit. The sample size would be 76 subjects. The researcher or research assistant will meet family member needs in domains of information, support and giving assurance. Some actions in the domain of support include what the family member can do at patient's bedside, and some explanations about the environment and bedside equipment and their application at first visiting. Some actions in the domain of information include introducing personnel and their task and that from whom they can take information, and some explanations about treatment plan. Some actions in the domain of giving assurance include providing understandable explanation about the disease and its progression and expected outcomes. Subjects in the control and trial groups complete the demographic questionnaire and Spielberger state anxiety inventory in the first day of patient admission. The nurse will meet family member needs in domains of information, support and giving assurance during the second and third days of patient admission. The fourth day, satisfaction questionnaire and Spielberger state anxiety inventory will be given to subjects in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110913785N2
Registration date:2014-03-12, 1392/12/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-12, 1392/12/21
Registrant information
Name
Hamid Peyrovi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4404
Email address
h-peyrovi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-01-02, 1392/10/12
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family-focused intervention on anxiety and satisfaction of family members of the intensive care unit patients
Public title
Effect of family-focused intervention on anxiety and satisfaction of family members of the intensive care unit patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: being the patient's husband, wife, brother, sister, father, mother or closest person in the family; being present at hospital in the first 24 to 48 hrs of admission; age more than 18 years old; emotioanlly prepared for taking part in the study; not taking care for another patient in the family; not having any history of close relatives admission at intensive care unit; not having physical or disability; not being the member of health care team
Exclusion Criteria: giving up for continuing participation in the study; patient death
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Ghods St., Keshavrz BLVD
City
Tehran
Postal code
1417653761
Approval date
2013-08-03, 1392/05/12
Ethics committee reference number
887/130/د/92
Health conditions studied
1
Description of health condition studied
Factors influencing health status and contact with health services
ICD-10 code
Z63.7
ICD-10 code description
Ill or disturbed family member
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention and the fourth day after interventio
Method of measurement
Spielberger state anxiety inventory
2
Description
Satisfaction
Timepoint
The fourth day after intervention
Method of measurement
Family Satisfaction in the Intensive Care Unit
Secondary outcomes
empty
Intervention groups
1
Description
For experimental group, the researcher assistants introduces him/herself to family member as soon as possible after patient's admission (after the essential affairs for the patient were done and family member got ready for receiving the intervention) and give some information about ward environment, regulations, necessary contact numbers. During second and third days of patient admission, the researcher assistant will meet family member's needs in domains of information, support and assurance.
Category
Other
2
Description
Control group only receives routine care delivered by ward personnel and no action would be done by the researcher.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasool-E-Akram Research, Medical and Educational Center
Full name of responsible person
Hamid Peyrovi
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abbas Motevallian
Street address
Hemmat and Sheikh Fazlollah Highways Crossroad
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Hamid Peyrovi
Position
Ph.D/ Faculty member
Other areas of specialty/work
Street address
Rashid Yasemi St., Vali-Asr Ave
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
hamidpeyravi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Hamid Peyrovi
Position
Ph.D
Other areas of specialty/work
Street address
Rashid Yasemi St., Vali-Asr Ave
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
hamidpeyravi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Hamid Peyrovi
Position
Ph.D
Other areas of specialty/work
Street address
Rashid Yasemi St., Vali-Asr Ave
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
hamidpeyravi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)