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Evaluation of the Effect of Reinforced Education on the Satisfaction of the Patients Undergoing Colonoscopy

Protocol summary

Study aim
Evaluation of the Effect of Reinforced Education on the Satisfaction of the Patients Undergoing Colonoscopy
Design
The study was a clinical trial with a control group, with parallel groups, Single blind with the participation of 84 colonoscopy candidates. Randomization was done using white and black colored cards
Settings and conduct
Candidate colonoscopy patients referred to Ayatollah Taleghani Medical Training Center in Tehran, if eligible, were included in the study and were randomly assigned to intervention and control groups using colored cards. This study was conducted in a Single blind manner. The researcher A taught the patients and the questionnaires were completed by researcher B, who was 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 had access to virtual space and educational videos and had no movement, hearing and vision disorders and had no medical history of suffering from cognitive diseases and depression and taking neuropsychiatric drugs participated in the study.
Intervention groups
In the intervention group, Reinforced Education was given using media along with pamphlets. In this way, the day before the colonoscopy, the patients were contacted and educational files about bowel preparation, including clips, software, and Instagram pages, were sent to them through Whats App, and their questions were answered. The usual education in control group was using a education pamphlet sheet.
Main outcome variables
Satisfaction, anxiety and bowl preparation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210131050189N5
Registration date: 2023-04-06, 1402/01/17
Registration timing: retrospective

Last update: 2023-04-06, 1402/01/17
Update count: 0
Registration date
2023-04-06, 1402/01/17
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
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
2022-05-22, 1401/03/01
Actual recruitment end date
2022-08-21, 1401/05/30
Trial completion date
2022-09-21, 1401/06/30
Scientific title
Evaluation of the Effect of Reinforced Education on the Satisfaction of the Patients Undergoing Colonoscopy
Public title
Evaluation of the effect of reinforced education on colonoscopy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
be a colonoscopy candidate access to cyberspace and educational videos
Exclusion criteria:
Having movement disability, hearing and vision disorders Having a medical history of suffering from cognitive diseases and depression Taking neuroleptics
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Actual sample size reached: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Before the intervention, 40 white cards and 40 black cards were prepared. All the cards were placed in an envelope, then the cards were taken out randomly and numbered from 1 to 80 in order of removal. Then each card was placed in a sealed envelope and its number was written on the envelope. As each patient entered the study, a special envelope from number 1 to 80 was opened for him. If the card was white, the participant was assigned to the intervention group, and if the card was black, the participant was assigned to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The training was given by Researcher A and the results were evaluated by Researcher B, who was unaware of the allocation of groups.Also, the data analyst will not know the type of intervention.
Placebo
Not used
Assignment
Parallel
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
Street address
Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-02-27, 1400/12/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.1082

Health conditions studied

1

Description of health condition studied
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 Irritable bowel syndrome 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
K50.1
ICD-10 code description
Crohn's disease of large intestine

Primary outcomes

1

Description
Patient satisfaction
Timepoint
48 hours after colonoscopy
Method of measurement
researcher made tool for satisfaction

2

Description
health anxiety
Timepoint
before and after education
Method of measurement
health anxiety inventory

3

Description
bowl preparation
Timepoint
an colonoscopy
Method of measurement
The Boston Bowel Preparation Scale (BBPS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: On the day of going to the clinic, pamphlets were given to the participants regarding the use of laxatives for bowel preparation. In the reinforced education, on the day before the colonoscopy, the time to use laxatives and adherence to a fiber-free diet were emphasized in a phone call, and reminder messages were sent to them. Also, through Instagram and WhatsApp, educational files about bowel preparation, including clips and software, were sent to them and their questions were answered.
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 21 8820 2520
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
By email to the corresponding author
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