The aim of this study is to assess the impact of nursing care on patients' anxiety level before the surgery. In this study, anxiety level compare in two control and experimental groups during admission and before anesthetize. 60 women patients, aged between 15 and 65 years who are considered for elective surgeries (Tubal ligation, hysterectomy, cesarean section), will be divided in to two control and experimental groups randomly. In experimental group, researcher visits patients the day before surgery. In case any diagnosis such as anxiety, lack of awareness or fear, nurse presents required training. Researcher transfers the patient to surgery room and introduces her to surgery team. The control group only receive routine care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106286910N1
Registration date:2011-10-16, 1390/07/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-16, 1390/07/24
Registrant information
Name
Mohammad Ali Soleimany
Name of organization / entity
Qazvin university of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 7267
Email address
masoleimany@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Qazvin University of Medical Sciences and Health Services
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of preoperative nursing care program on anxiety level of women undergoing surgery
Public title
Impact of preoperative nursing care program on anxiety level of women undergoing surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Elective surgery (Tubal ligation, hysterectomy, cesarean section); Age between 15 and 65 years; Ability to communicate.
Exclusion criteria: Hearing and vision problems; Drug addiction or use of tranquilizers; Epilepsy and mental illness; Thyroid disease; Hypocalcemia; cardiovascular diseases; Receiving anti-anxiety medication before surgery; Use of corticosteroid drugs.
Age
From 15 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences and Health Services
Street address
Faculty of nursing and midwifery, Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2010-11-24, 1389/09/03
Ethics committee reference number
56
Health conditions studied
1
Description of health condition studied
Anxiety levels before surgery
ICD-10 code
F00-F09
ICD-10 code description
Organic, including symptomatic, mental disorders
Primary outcomes
1
Description
Anxiety before surgery
Timepoint
Morning of surgery day
Method of measurement
Preoperative Anxiety Scale and the awareness Amsterdam
Secondary outcomes
1
Description
Cortisol of Serum
Timepoint
Morning of surgery day at 8 o'clock
Method of measurement
Using laboratory techniques
2
Description
Vital signs (respiration rate, pulse rate, heart rate and systolic and diastolic blood pressure)
Timepoint
At admission time and before surgery
Method of measurement
examination by researcher
Intervention groups
1
Description
In experimental group, researcher visits patients the day before surgery and then considers by using daily activities form. In case any nursing diagnosis such as anxiety, lack of awareness or fear, nurse shall present required training. During this visit, patients express their worry about the surgery. Then, by considering situation and perception level of patients, one or several ways for diminishing anxiety will be presented to them. Researcher transfers the patient to surgery room and introduces him to surgery team.
Category
Treatment - Drugs
2
Description
The control group only receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences and Health Services
Full name of responsible person
Dr Saeid Asef Zadeh
Street address
Vice chancellor for research, Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences and Health Services
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
Qazvin University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Ali Soleimany
Position
Faculty member, school of nursing and midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard
City
Qazvin
Postal code
Phone
+98 28 1223 7268
Fax
+98 28 1223 7268
Email
soleimany.msn@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences and Health Services, Faculty of Nursing and Midwifery
Full name of responsible person
Nasim Bahrami
Position
Faculty member, school of nursing and midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 1223 7267
Fax
+98 28 1223 7268
Email
nbahrami87@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Ali Soleimany
Position
Faculty member, school of nursing and midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 1223 7267
Fax
+98 28 1223 7268
Email
soleimany.msn@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)