Investigating the effect of using a mobile app on preparation and anxiety before colonoscopy
Design
The study will be conducted as a clinical trial with a control group, with parallel groups, one side blind, with the participation of 80 colonoscopy candidate patients. Randomization will be done using white and black colored cards
Settings and conduct
Candidate colonoscopy patients referred to Ayatollah Taleghani Medical Training Center in Tehran, if eligible, will be included in the study and will be randomly assigned to intervention and control groups using colored cards. This study will be performed in a blind way. Researcher A teaches the patients and the questionnaires are completed by Researcher B, who will be unaware of the allocation of groups. Also, the data analyst did not know the type of intervention.
Participants/Inclusion and exclusion criteria
Candidates for colonoscopy who have a smartphone and the ability to use it and who have no medical history of suffering from cognitive diseases and depression and taking neuropsychiatric drugs will be included in the study.
Intervention groups
In the intervention group, training will be given using the mobile app prepared about colonoscopy (reasons, how to perform, how to prepare and consume laxatives, ensuring readiness) and in the regular group, training will be done with a bowel preparation pamphlet.
Main outcome variables
Bowl Preparation, Colonoscopy anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210131050189N6
Registration date:2023-11-01, 1402/08/10
Registration timing:prospective
Last update:2023-11-01, 1402/08/10
Update count:0
Registration date
2023-11-01, 1402/08/10
Registrant information
Name
Raziyeh Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 4520
Email address
ghafouri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-02, 1402/08/11
Expected recruitment end date
2024-01-31, 1402/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using a mobile application on preparation and anxiety before colonoscopy
Public title
Use of mobile application on preparation and anxiety before colonoscopy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
be a colonoscopy candidate
Having a smart phone
Exclusion criteria:
Inability to use a smartphone
Having a medical history of suffering from cognitive diseases and depression or taking neuroleptics
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the research, 40 white color cards and 40 black cards will be prepared. All the cards will be placed in an envelope, then the cards will be taken out randomly and numbered from 1 to 80 in order of exit. Each card will then be placed in a sealed envelope and its number will be written on the envelope. As each patient enters the study, a special envelope from number 1 to 80 will be opened for him. If the card is white, the participant will be assigned to the intervention group, and if the card is black, the participant will be assigned to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The training will be given by Researcher A and the results will be evaluated by Researcher B, who will be unaware of the allocation of groups. Also, the data analyst will not know the type of intervention
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University of Medical Sciences
Suspected neoplasm of colon who were candidates for colonoscopy
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
2
Description of health condition studied
Suspected neoplasm of colon who were candidates for colonoscopy
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
3
Description of health condition studied
Crohn's disease
ICD-10 code
K50
ICD-10 code description
Crohn's disease [regional enteritis]
Primary outcomes
1
Description
Bowl Preparation
Timepoint
an colonoscopy
Method of measurement
The Boston Bowel Preparation Scale (BBPS)
2
Description
Colonoscopy Anxiety
Timepoint
After Colonoscopy
Method of measurement
Colonoscopy anxiety tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On the day of going to the clinic and making an appointment for colonoscopy, the mobile application is provided, and after installation, training was given and followed up with it. The program contains information related to the causes of colonoscopy, preparation for colonoscopy, evaluation of the patient's readiness, and evaluation of the patient's medications and underlying diseases.
Category
Early detection
2
Description
Control group: On the day of going to the clinic, pamphlets were given to the participants regarding the use of laxatives for bowel preparation,
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
(Ayatollah) Taleghani Educational Hospital
Full name of responsible person
Raziyeh Ghafouri
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2303 1100
Email
taleghani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
َAfshin Zergi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 912 783 8896
Email
raziehghafouri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
By email to the corresponding author
When the data will become available and for how long
َAfter the publication of the article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
More research
From where data/document is obtainable
By email to the corresponding author
What processes are involved for a request to access data/document