reduction of the anxiety of patient before colonoscopy by multimedia intervention
Design
Patients based on the date referring to the clinic divided into two groups assigned randomly by using the website www.randomaize.com. Overall, 36 patients divided into two control and intervention groups (n=18).
Control group received an educational booklet about colonoscopy, whereas patients in the intervention group watched a video clip about colonoscopy procedures in addition to the educational booklet.
The booklet contents compiled from uptodate.com website and edited by a gastroenterologist. Content validity of the booklet is approved by the opinion of five experts. Video clip is perpared according to the booklet contents. The rate of anxiety and knowledge of patients before intervention (at the time of the physical examination) and before colonoscopy will be compared. Also, the rate of tranquilizer administration during colonoscopy in both groups will be compared.
Settings and conduct
All patients complete Spielberger knowledge and anxiety questionnaire and will receive an educational booklet. Patients in the intervention group will watch an educational video clip. On the day of colonoscopy in endoscopy section of Qaem hospital, patients will complete Spielberger knowledge and anxiety questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 30-70, reading literacy, candidate for the colonoscopy because four reasons include: of rectology, abdominal pain, changes in bowel habit, iron deficiency anemia.
Exclusion criteria: history of colonoscopy. if the interval between visit and colonoscopy is more than 10 days
Intervention groups
Intervention group receive colonoscopy educational booklet and watch a video clip about colonoscopy.
Control group receive colonoscopy educational booklet.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180904040943N1
Registration date:2018-10-26, 1397/08/04
Registration timing:registered_while_recruiting
Last update:2018-10-26, 1397/08/04
Update count:0
Registration date
2018-10-26, 1397/08/04
Registrant information
Name
Nooshin Dayani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3727 3735
Email address
dayanin1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-20, 1397/07/28
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of a Multimedia education intervention on anxiety before colonoscopy procedures.
Public title
the effects of a education intervention on anxiety before colonoscopy procedures.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
female
able to read
age between 30-70
One of the four factors to be candidate for colonoscopy: rectology, pain stomach, Changes in bowel habits, iron anemia
Exclusion criteria:
history of colonoscopy
Age
From 30 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
random sampling, individual, tools:randomization website
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
Ethic committee of mashhad university of medical sciences
Street address
mashhad university of medical science, ghorishi building, daneshgah st. masshad
City
mashhad
Province
Razavi Khorasan
Postal code
951-91735
Approval date
2018-07-18, 1397/04/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.025
Health conditions studied
1
Description of health condition studied
Digestive problems
ICD-10 code
D01
ICD-10 code description
Carcinoma in situ of other and unspecified digestive organs
Primary outcomes
1
Description
Change rate in spielberger anxiety scale in patients candidate for colonoscopy
Timepoint
Amount of anxiety in patients was evaluated before the intervention. After that, a booklet is given to both intervention and control group. In addition to the booklet, patients in the intervention group watched an educational film at the office. After the intervention, amount of anxiety in both groups was evaluated on the colonoscopy day.
Method of measurement
spielberger anxiety questionnaire
Secondary outcomes
1
Description
knowledge's patient about colonoscopy
Timepoint
visit time in clinic (before intervention), after intervention in colonoscopy day in andoscopy ward
Method of measurement
Researcher made Questionnaire
2
Description
The amount of tranquilizer administration during colonoscopy.
Timepoint
during colonoscopy
Method of measurement
milliliter
3
Description
Duration of Culmonoscopy
Timepoint
during colonoscopy
Method of measurement
minute
Intervention groups
1
Description
Patients in the intervention group received a colonoscopy educational booklet and watched a video clip about colonoscopy procedures.
Category
Other
2
Description
Patients in the control group only received colonoscopy educational booklet.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
qhaem hospital mashhad university of medical science
Full name of responsible person
nooshin dayani
Street address
informatic group, medical faculty, mashhad university of medical science, park square, mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3845 4344
Email
dayanin1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
mashhad university of medical science
Full name of responsible person
dr. tafaghodi
Street address
mashhad university of medical science, ghorishi building, daneshgah st. masshad
City
mashhad
Province
Razavi Khorasan
Postal code
ghorshi builging, da
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
mashhad university of medical science
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
Mashhad University of Medical Sciences
Full name of responsible person
nooshin dayani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
mathematics science
Street address
Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3845 4344
Email
dayanin1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Hasibian
Position
educational academic staff
Latest degree
Master
Other areas of specialty/work
Computer Engineering (Artificial Intelligence)
Street address
Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2440
Email
hasibianmr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
nooshin dayani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
mathematic
Street address
Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3845 4344
Fax
Email
dayanin1@mums.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available