Effect of Visualization on Preoperative Anxiety in Patients Candidate for Urology Endoscopic Surgery
Design
This study is an interventional study in a two-group randomized clinical trial including control group and intervention group.In this study,120 patients with 30 intervention and 30 control (TUL & TURBT)patients,respectively,were all eligible for inclusion.They will be randomly assigned to four blocks by random blocking method and will participate in the study.
Settings and conduct
The research setting is the Urology Department of Bahonar Hospital of Kerman. All patients who have a definitive diagnosis of a bladder tumor or urinary stones from a specialist doctor's referral to the Urology Department and who meet the inclusion criteria are eligible for inclusion.The intervention is intuitive through visual and auditory animation.The night before surgery, the researcher identifies eligible patients for inclusion in the study and will enter the study if they score above 43 on the STAI scale.Patients identified in the intervention group will then see the surgical animation in the group conference room. After the intervention and one hour before surgery, the questionnaire will be completed again.In this single-blind study, sampling will be done by people who are unaware of the nature of the groups and can also be randomly selected by someone who is unaware of the groups.
Participants/Inclusion and exclusion criteria
Patients undergoing Trans Urethral Lithotripsy (TUL) or Trans Urethral Resection of Bladder (TURBT) surgery
Ability to communicate in Persian
Age over 20 years
Get a minimum score of 43 on the State-Trait Anxiety Inventory (STAI) scale in two sub-scales (explicit and hidden)
Intervention groups
Intervention: In this study, intuitive visual and auditory animation is used.
Control: The control group only receives routine care.
Main outcome variables
Anxiety, Visualization, Age
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190413043251N1
Registration date:2020-06-14, 1399/03/25
Registration timing:retrospective
Last update:2020-06-14, 1399/03/25
Update count:0
Registration date
2020-06-14, 1399/03/25
Registrant information
Name
Mohammad Javad Mahdizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3343 3099
Email address
mj.mahdizadeh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Visualization on Preoperative Anxiety in Patients Undergoing Endoscopic Urology Surgery
Public title
The Effect of Visualization on Anxiety in Urology patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing TURBT or TUL surgery
Ability to communicate in Persian
Age over 20 years
Get a minimum score of 43 on the STAI scale in two sub-scales (State and Trait)
Exclusion criteria:
Patients who have been diagnosed with an specialist physician who has anxiety, depression or severe or emergency complications
Anyone who refuses to continue companionship for any reason during the study will be excluded from the study and replaced by predetermined eligible individuals.
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants will be selected on the basis of hospital admission and inclusion criteria. Then random allocation will be done by block with four blocks so that every night, eligible people will be palced in intervention group based on computer-assinged block and as the intervention group will be identified every night, there will be a group intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blind study, sampling will be done by people who are unaware of the nature of the groups and can also be randomly selected by someone who is unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
7 Bagh e Alavi/ Campus of Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-06-01, 1399/03/12
Ethics committee reference number
IR.KMU.REC.1399.155
Health conditions studied
1
Description of health condition studied
Bladder Tumor
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
2
Description of health condition studied
Urolithiasis
ICD-10 code
N21
ICD-10 code description
Calculus of lower urinary tract
Primary outcomes
1
Description
Anxiety score in Spielberger (STAI) questionnaire
Timepoint
Anxiety measurement at the beginning of the study (before the intervention)
Method of measurement
State-Trait Anxiety Inventory (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention in this study is Visualization through visual and auditory animation. The researcher, after obtaining the appropriate animation about the type of surgery, will submit the file to the urologist for appropriate assessment of the type of surgery; Sound will be added to the images after the animation has been confirmed by the Urologist. The approximate time of animation and presentation is 15 minutes. Patients in the intervention group will be seen surgery animations as a group in conference room .
Category
Treatment - Other
2
Description
Control group: Patients in the control group will receive only routine surgical care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Reza Mohammadi
Street address
Gharani Street
City
Kerman
Province
Kerman
Postal code
76137-47181
Phone
+98 34 3223 5011
Email
reza.m2034@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Campus of Kerman Uni of Med Sci, 7Bagh Alavi
City
Kerman
Province
Kerman
Postal code
76167-13555
Phone
+98 34 3132 5700
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Javad Mahdizadeh
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Campus of Kerman Uni of Med Sci, 7Bagh Alavi
City
Kerman
Province
Kerman
Postal code
76167-13555
Phone
0343-31325700
Email
mahdizadeh.4014@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Javad Mahdizadeh
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Campus of Kerman Uni of Med Sci, 7Bagh Alavi
City
Kerman
Province
Kerman
Postal code
76167-13555
Phone
0343-31325700
Email
mahdizadeh.4014@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Javad Mahdizadeh
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Campus of Kerman Uni of Med Sci, 7Bagh Alavi
City
Kerman
Province
Kerman
Postal code
76167-13555
Phone
0343-31325700
Email
mahdizadeh.4014@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available