Objective: This study aimed to Investigation The effect of Early communication on patients anxiety before surgery in Alzahra hospital of Isfahan city in 2014. Methods: This study is a clinical trial, Two groups and two phases . In this study, male and female patients undergoing general surgery and qualified for the study, would selected randomly. then based on odd or even numbers of records, they would assigned in two groups of experimental and control groups. Patients in the experimental group after the first introduction to the researcher and inform the main reason for his visit, will talk about medical history, family history, history of hospitalization and use of certain medications. Then researcher will inform patients about anesthesia and surgery and they will be encouraged to express their concerns in relation to the surgery. Patients in the control group will just present in the room for 10 minutes and then complete questionnaires. both groups will answer a Amsterdam anxiety questionnaire in two stages: before and immediately after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015073120833N2
Registration date:2015-09-20, 1394/06/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-20, 1394/06/29
Registrant information
Name
Samira Abbasi
Name of organization / entity
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3228 7822
Email address
s.abbasi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Isfahan University of Medical Sciences
Expected recruitment start date
2014-09-21, 1393/06/30
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Early communication on patients anxiety before surgery
Public title
Investigation The effect of Early communication on patients anxiety before surgery in Alzahra hospital of Isfahan city in 2014
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: willingness to participate in the study; absence of confronting severe mental anxiety in recent weeks; having Elective surgery with general anesthesia; Aged between 18 to 60 years; Ability to read and write; exclusion criteria: emergent surgery; Visual impairment; any drug substance abuse or being in ASA 3 and above(a measure of anesthesia).
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
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
Isfahan University of Medical Sciences, School of Nursing and Midwifery
Street address
isfahan, hezarjarib Ave.
City
isfahan
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
293078
Health conditions studied
1
Description of health condition studied
pre operation Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
before and immidiately after the intervention
Method of measurement
Amsterdam Preoperative Anxiety questionnier
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the experimental group after the first introduction to the researcher and informing the main reason for his visit, will talk about medical history, family history, history of hospitalization and use of certain medications. Then researcher will inform patients about anesthesia and surgery and they will encourage to express their concerns in relation to the surgery.
Category
Other
2
Description
in the control group, researcher will just present in the patients room for 10 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital in Isfahan
Full name of responsible person
Leila Akbari
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of Isfahan University of Medical Sciences
Full name of responsible person
Leila Akbari
Street address
Isfahan , Hezarjarib Avenue
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of 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, School of Nursing and Midwifery
Full name of responsible person
Leila Akbari
Position
MSc of nursing, Faculty member of Operating Room group, School of Nursing and Midwifery
Other areas of specialty/work
Street address
Hezarjarib, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2960
Fax
Email
l_akbari@nm.mui.ac.irs.abbasi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of nursing and midwifery, Isfahan university of medical sciences, Isfahan
Full name of responsible person
Samira Abbasi
Position
Msc of Psychiatric Nursing
Other areas of specialty/work
Street address
isfahan, hezarjarib Ave.
City
isfahan
Postal code
Phone
+98 31 3792 2960
Fax
Email
l_akbari@nm.mui.ac.irs.abbasi@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Samira Abbasi
Position
Msc of Psychiatric Nursing
Other areas of specialty/work
Street address
Isfahan , Hezarjarib Avenue
City
Isfahan
Postal code
Phone
00
Fax
Email
s.abbasi@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)