This study explores the effect of preoperative nursing visit on anxiety and postoperative outcomes of laparoscopic cholesystectomy. Demographic and personality data will be collected during preoperative nursing visit. In the afternoon of the day before the operation, in a 30 minutes session with patient the following information will be provided for the intervention group: information about the operation room, the admissions process in the operating room, and the type of surgical procedure. The advantages of laparoscopic surgery over the conventional methods will be described. A series of techniques to help with the rapid recovery of the patient following surgery will be given including: doing deep breathing, and early ambulation. The control group will receive the routine care. protocol of anesthesia and pain control will be the same for all of participants. At the morning of the surgery day Speilberger state – trait anxiety inventory questionnaire will be filled for all the patients participating in the study. Vital signs and other possible complications will be monitored for patients. At the recovery room Aldert’s checklist will be completed. Patient’s pain, nausea and vomiting will be assessed 24 hours after operation. The collected information will be compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008253384N2
Registration date:2010-09-28, 1389/07/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-28, 1389/07/06
Registrant information
Name
Ameneh Ebrahim Valoojerdi
Name of organization / entity
Endocrine research center
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5247
Email address
info@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-08-01, 1389/05/10
Expected recruitment end date
2010-11-01, 1389/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative nursing visit on anxiety and postoperative outcomes of laparoscopic cholesystectomy
Public title
Effect of preoperative nursing visit on anxiety and postoperative outcomes of laparoscopic cholesystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Lack of underlying physical illness, including heart disease - cardiovascular, pulmonary, renal and mental illness, lack of surgical experience
And lack of familiarity with the operating room environment , being undergone elective surgery
Exclusion criteria : acute and chronic cholecystitis
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
125
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
Iran university of Medical sciences
Street address
Iranian university of Medical sciences - Hemat highway
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
2/891
Health conditions studied
1
Description of health condition studied
Behavior Therapy
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Anxiety
Timepoint
24 hours before surgery, 24 hours after surgery
Method of measurement
Questionnaire
2
Description
Nausea
Timepoint
24 hours before surgery, 24 hours after surgery
Method of measurement
Patient records
3
Description
pain
Timepoint
24 hours before surgery, 24 hours after surgery
Method of measurement
Visual Analouge Scale
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
After discharge
Method of measurement
Patient file
Intervention groups
1
Description
Intervention group: in the afternoon of the day before the operation, in a 30 minutes session with patient the following information will be provided: information about the operation room, the admissions process in the operating room, and the type of surgical procedure. The advantages of laparoscopic surgery over the conventional methods will be described. A series of techniques to help with the rapid recovery of the patient following surgery will be given including: doing deep breathing, and early ambulation
Category
Behavior
2
Description
Control group: as usual approach
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Street address
City
Karaj
2
Recruitment center
Name of recruitment center
Alborz Hospital
Full name of responsible person
Street address
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran university of Medical sciences
Full name of responsible person
Dr Maziar Moradi
Street address
Iran university of Medical sciences, Hemat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?