Determining the effect of clinical familiarization training on anxiety, pain and satisfaction of endoscopic candidate patients
Design
Clinical trial with control group, with parallel, randomized, phase 3 groups on 60 patients. Randomization is used for the drawing.
Settings and conduct
Intervention group: The intervention group receives in addition to routine ward training, clinical familiarization intervention with endoscopic procedure. Clinical familiarization is held in the form of a 30-40 minute tour. In the morning before the end of the procedure, after obtaining informed consent, they are transferred to the endoscopy unit and get acquainted with the endoscopy unit, equipment, equipment, medicines and observe how a patient performs endoscopy, then about how to perform endoscopy procedure. Post-procedure clinical care is also described. The researcher also answers patients' questions during this time.
Participants/Inclusion and exclusion criteria
Perform endoscopy
No history of endoscopy
Intervention groups
Intervention group: The intervention group receives in addition to routine ward training, clinical familiarization intervention with endoscopic procedure. Clinical familiarization is held in the form of a 30-40 minute tour (12). In the morning before the end of the procedure, after obtaining informed consent, they are transferred to the endoscopy unit and get acquainted with the endoscopy unit, equipment, equipment, medicines and observe how a patient performs endoscopy, then about how to perform endoscopy procedure. Post-procedure clinical care is also described. The researcher also answers patients' questions during this time.
Main outcome variables
Anxiety, satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171002036498N4
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Ali Akbari
Name of organization / entity
Medical Sciences of Rafsanjan University
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
iccn@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of clinical orientation teaching on anxiety, pain and satisfaction of patients candidating for endoscopy
Public title
Investigating the effect of clinical orientation teaching on anxiety, pain and satisfaction of patients candidating for endoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Prescribed endoscopy
No history of endoscopy
Non-emergency endoscopy
No cognitive problems
No physical disability
Do not be deaf
No visual impairment
No history of mental illness
Do not have severe pain due to other diseases (cancer, etc.)
Ability to speak Persian
Exclusion criteria:
Uncooperative patient to continue
The patient becomes ill or has a complication
Use more sedatives than usual
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method will be available. Samples are randomly assigned to the control and intervention groups based on age and sex variables. In this method, the first samples (20%) are randomly entered into the study and placed in each group. For the following examples, the sum of the indicators in the two groups is considered and the sample is assigned to the group that has a lesser sum.
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 Rafsanjan University of Medical Sciences
Street address
N0.1, motahari Blvd.
City
Rafsanjan
Province
Kerman
Postal code
771879755
Approval date
2019-07-17, 1398/04/26
Ethics committee reference number
IR.RUMS.REC.1398.073
Health conditions studied
1
Description of health condition studied
Gastrointestinal patients
ICD-10 code
K92.2
ICD-10 code description
Gastrointestinal hemorrhage, unspecified
Primary outcomes
1
Description
Anxiety: The score that patients receive from the Spielberger situational questionnaire This numerical score is higher than 43.
Timepoint
Before and after the intervention
Method of measurement
Spielberger Anxiety Scale.
2
Description
satisfaction: The patient's feeling is about the performance of the treatment team, the condition of the disease and the diagnostic-therapeutic methods
Timepoint
Before and after the intervention
Method of measurement
Satisfaction Questionnaire
Secondary outcomes
1
Description
Unpleasant sensation and emotional experience
Timepoint
After the intervention
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Intervention group: The intervention group receives in addition to routine ward training, clinical familiarization intervention with endoscopic procedure. Clinical familiarization is held in the form of a 30-40 minute tour . In the morning before the end of the procedure, after obtaining informed consent, they are transferred to the endoscopy unit and get acquainted with the endoscopy unit, equipment, equipment, medicines and observe how a patient performs endoscopy, then about how to perform endoscopy procedure. Post-procedure clinical care is also described. The researcher also answers patients' questions during this time. After the endoscopy is performed, another patient is transferred to the endoscopy room. After receiving lidocaine spray and sedative injection, while lying on your left side, the doctor guides the endoscope tube through the mouth to the throat. After passing the endoscope tip through the throat, the researcher transfers the patient to the endoscopy room and the patient observes the endoscopy procedure closely. Observation includes the operation of equipment, monitors, methods of taking pictures of the gastrointestinal tract, sampling, etc. The patient returns to the waiting room before the endoscope is removed. Their questions will be answered during this period. It takes at least two hours for the patient to return to the endoscopy department for endoscopy, before the endoscopy the anxiety questionnaire is completed again. During this period, the patient has enough time to get answers to his questions based on the observations.
Category
N/A
2
Description
control group: Receive routine ward training, including nurse training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebn-Abitaleb hospital
Full name of responsible person
Ali Akbari
Street address
No. 7, Benafshe Ave., West Shariati Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7719717653
Phone
+98 34 3426 2818
Email
iccn87@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
No. 7, Benafshe Ave., West Shariati Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717917653
Phone
+98 34 3426 2818
Email
iccn87@gmail.com
Grant name
Ali Shamsizadeh
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Akbari
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 7, Benafshe Ave., West Shariati Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7719717653
Phone
+98 34 3426 2818
Email
iccn87@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Akbari
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 7, Benafshe Ave., West Shariati Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7719717653
Phone
+98 34 3426 2818
Email
iccn87@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Akbari
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 7, Benafshe Ave., West Shariati Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7719717653
Phone
+98 34 3426 2818
Email
iccn87@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available