The objective of this study is to determine the effects of nursing consultation on the anxiety level of the patient before gastrointestinal endoscopy and their satisfaction about it. In this quasi- experimental study in Amiralmomenin hospital of Arak, 120 patients are scheduled to undergo upper GI Endoscopy. The patients are randomly allocated to experimental or control group. The patients in the experimental group receive intervention of nursing consultation lasted 30 minutes about endoscopy a day before the procedure, while control group does not receive any intervention. Anxiety level (recorded by spielburger questionnaire) and vital signs are measured in both groups before intervention and on the endoscopy day (immediately before the procedure). During the endocscopy, the cooperation of the patients and their satisfaction are measured by VAS, 6 hours after endoscopy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103256103N1
Registration date:2011-10-22, 1390/07/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-22, 1390/07/30
Registrant information
Name
Olia Bakhshayeshi
Name of organization / entity
Tehran Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 2700
Email address
zparsa@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Implementing Nursing Consultation on" "Anxiety and Satisfaction of Patients Undergoing GI Endoscopy
Public title
The effectiveness of Implementing Nursing Consultation on" "Anxiety and Satisfaction of Patients Undergoing GI Endoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having order of upper GI Endoscopy at least one day before the procedure, Age between 18 and 80 years old, Ability to speak and understanding Persian language, no problem to see the VAS, no previous endoscopy, no order of emergency Endoscopy, no History of psychological disease or anxiety disorder, no consumption of opiate or sedative drugs, no severe pain due to nature of disease, no addiction to opium or narcotics, no hypertension or using anti hypertensive drugs
Exclusion criteria: canceling the Endoscopy due to any reason except for patient’s anxiety, no willingness to participate in the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central building of TUMS, Ghods street, Keshavarz Blvd., Tehran
City
Tehran
Postal code
6514- 151684
Approval date
2010-08-10, 1389/05/19
Ethics committee reference number
620/130/د/89
Health conditions studied
1
Description of health condition studied
Uper GI Endoscopy
ICD-10 code
K20, K31
ICD-10 code description
Diseases of Oesophagus, Stomach and Duodenum
Primary outcomes
1
Description
Blood presure
Timepoint
One day before Endoscopy(before consultation) and immediately before Endoscopy
Method of measurement
indicator
2
Description
anxiety
Timepoint
One day before Endoscopy(before consultation) and immediately before Endoscopy
Method of measurement
spielberger questionair
3
Description
Cooperation
Timepoint
WHILE Endoscopy
Method of measurement
Visual Analog scale
4
Description
pulse rate
Timepoint
One day before Endoscopy(before consultation) and immediately before Endoscopy
Method of measurement
by researcher
5
Description
respiratory rate
Timepoint
One day before Endoscopy (before consultation) and immediately before Endoscopy
Method of measurement
by researcher
Secondary outcomes
1
Description
Patient's satisfaction
Timepoint
6 hours after Endoscopy
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
Intervention group: consultation for half an hour one day before Endoscopy. This consultatoin is performed by researcher for out-patients in hospital or patient home(at tendency of patient) and for inpatients on the bed of patient . This consoltation is nursing cosultation and do not need to advanced techniques of psicologia. This consoltation is including instruction about needing preparation pre Endoscopy (such as diet, drugs,...), explanation about stages pre(instruction necessary preparations), in(explanation about What will happen during Endoscopy)) and after(explanation about the probable problems that will meet after Endoscopy ) Endoscopy. It increase patient knowledge about Endoscopy and its advantages and probable risks and allow to patient that express his sensations and questions and answering the questions of patient.
Category
Treatment - Other
2
Description
Control group: No intervention other than routine care