This experimental study aimed to evaluate the effect of nursing intervention on anxiety in patients undergoing endoscopy and it will be performed with participation of 80 patients undergoing endoscopy referred to Ayatollah Taleghani hospital of Urmia in 2014. Samples will allocated by simple random sampling to either experimental (n=40) or control groups (n= 40). So that endoscopy candidates of even days will be placed in the control group and patients of odd days in the intervention group. Inclusion criteria include: Having order for upper gastrointestinal endoscopy, aged 18 to 60 years and without history of previous endoscopy. The use of hypnotics and sedatives, having severe pain due to the nature of the disease (eg, cancer), opioid material addiction or strong analgesics are exclusion criteria. The experimental group will receive nursing interventions include training preparation before the procedure, explaining about all the steps before, during and after endoscopy, the patient's awareness, deep breathing training and positive mental reinforcement in patient about endoscopy and endoscopy day, while the control group will not receive any intervention. Anxiety level will be measured in both groups before intervention and on endoscopy day (immediately before the procedure).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031817059N1
Registration date:2014-06-27, 1393/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
Registrant information
Name
Masoume Hemmati Maslakpak
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1365 9031
Email address
hemmati_m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences.
Expected recruitment start date
2014-06-21, 1393/03/31
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to compare the effectiveness of nursing interventions and lack of nursing interventions on anxiety in patients undergoing endoscopy
Public title
Effect of nursing interventions on anxiety in patients undergoing endoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having order for upper gastrointestinal endoscopy, aged 18 to 60 years, without history of previous endoscopy, without emergency endoscopy order and Iranian nationality.
Exclusion criteria: The use of hypnotics and sedatives, having severe pain due to the nature of the disease (eg, cancer), opioid material addiction or strong analgesics.
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:
80
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
Ethics committee of Urmia University of Medical Sciences
Street address
Jahad square, University of Medical Sciences, Urmia
City
Urmia
Postal code
575611-5111
Approval date
2014-05-20, 1393/02/30
Ethics committee reference number
umsu.rec.1393.69
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is
Primary outcomes
1
Description
Anxiety
Timepoint
Before endoscopy and half hour before endoscopy in procedure day
Method of measurement
Spielburger Anxiety questionnaire
Secondary outcomes
1
Description
Systolic and diastolic blood pressure, pulse rate
Timepoint
Before endoscopy and half an hour before endoscopy in procedure day
Method of measurement
Using mercury sphygmomanometer and radial pulse by nurse
Intervention groups
1
Description
Intervention 2: Lack of nursing intervention before of procedure
Category
Behavior
2
Description
Intervention 1: Nursing intervention: Training preparation before the procedure involves fasting for 8 hours before the procedure , how to use a local anesthetic throat to eliminate Gag reflex before the procedure , observe the lateral position left during the procedure , the possibility of using certain drugs such as atropine to reduce secretions and glucagon to relax the muscles , showing the endoscopy setting , explain all procedures before, during and after endoscopy , the patient's awareness about the benefits and risks, giving the patient the opportunity to express feelings and questions, Responding to questions posed by the patient , deep breathing training, patients positive mental reinforcement to support them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani hospital of Urmia
Full name of responsible person
Samira Orujlu
Street address
Nursing and Midwifery Faculty,11 km Sero road, Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Jahad square, Urmia University of medical sciences
City
Urmia
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, Urmia 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Samira Orujlu
Position
Msc. Faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, 11 km Sero road, Urmia
City
Urmia
Postal code
575611-5111
Phone
+98 44 1275 4961
Fax
+98 44 1275 2378
Email
samira_orojlo@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Samira Orujlu
Position
Msc. Faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, 11 km Sero road, Urmia
City
Urmia
Postal code
575611-5111
Phone
+98 44 1275 4961
Fax
+98 44 1275 2378
Email
samira_orojlo@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)