Determination the effect of implementation of discharge plan on physiological and behavioral anxiety parameters in patients with diabetes mellitus
Design
A clinical trial with a control group, randomized with quad blocks, parallel groups
Settings and conduct
The study is conducted in the internal diseases department of Imam Khomeini Hospital in Shirvan city. After half an hour after the patients understand the discharge order, anxiety questionnaire is completed by them and a sample of saliva is taken. Then the discharge program implement for intervention group and the control group receive the routine program. After half an hour, the questionnaire is completed and the saliva sample is taken again.
Participants/Inclusion and exclusion criteria
Patients with diabetes mellitus are admitted to the internal department of Imam Khomeini Hospital in Shirvan city.
inclusion criteria: Age more than eighteen years; Ability to reading and writing; Ability to understand and speak in Farsi; Ability to self care; Ability to speech and hearing; Absence of dementia and cognitive problem; Absence of endocrine gland diseases; Not taking medications that reduce or increase cortisol; Not taking anti-anxiety and tranquilizers; There is no underlying diseases; Desire to participate in the study
exclusion criteria: Not fasting; Brushing in 4-5 hours; Not having saliva (in some cases like Sjogren's syndrome); Presence of gingivitis; Unwilling to continue research; Discharge of the patient after 10 o'clock
Intervention groups
Intervention group: Implementing a complete and up-to-date discharge plan.
Control group: only receive routine training.
Main outcome variables
Salivary cortisol; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181112041627N1
Registration date:2018-12-24, 1397/10/03
Registration timing:registered_while_recruiting
Last update:2018-12-24, 1397/10/03
Update count:0
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
Mohsen Fooladzadeh Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3622 4373
Email address
mohsen.antisemitism12@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of implementation of discharge plan on physiological and behavioral anxiety parameters in patients with diabetes mellitus
Public title
Assessment the effect of implementation of discharge plan on anxiety in patients with diabetes mellitus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age more than eighteen years
ability to reading and writing
ability to understand and speak in Farsi
ability to self care
ability to speech and hearing
absence of dementia and cognitive problem
absence of endocrine gland diseases
not taking medications that reduce or increase cortisol (such as corticosteroids, anticonvulsants)
not taking anti-anxiety and tranquilizers (such as propranolol, clonazepam, etc.)
There is no underlying diseases
desire to participate in the study
Exclusion criteria:
Not fasting
Brushing during recent 4-5 hours
Not having saliva (in some cases like Sjogren's syndrome)
Presence of gingivitis
Unwilling to continue research
Discharge of the patient after 10 o'clock (due to stable salivary cortisol levels between 7 and 10 o'clock)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized method by quad blocks, The letter A for the intervention group and the letter B for the control group are considered. Then, all the reciprocal combinations of the letters A, A and B,B which are 6 different combinations, are written on 6 cards, and one digit of one to six digits is selected randomly. (By random number tables or from patient number one we want to choose a card randomly)
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 Tehran University of Medical Sciences
Street address
Tohid Square, Dr Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
North Khorasan
Postal code
1419733171
Approval date
2018-11-06, 1397/08/15
Ethics committee reference number
IR.TUMS.FNM.REC.1397.143
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
Diabetes m
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Anxiety Score in Beck's questionnaire
Timepoint
Anxiety Measurement at the beginning of the study (before the intervention) and half an hour after the intervention
Method of measurement
Anxiety Beck's questionnaire
2
Description
Salivary cortisol levels based on micrograms per deciliter
Timepoint
Anxiety Measurement at the beginning of the study (before the intervention) and half an hour after the intervention
Method of measurement
Saliva sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: implementation an educational program during discharge with the general definition of diabetes, blood glucose control, diet, exercise and activity, acute complications of diabetes and their prevention, chronic complications of diabetes and their prevention, rules of illness
Category
Lifestyle
2
Description
Control group: Routine training of ward
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Shirvan city
Full name of responsible person
Mozhdeh Navidhamidi
Street address
No. 7, Fourth Alley Forughi Ave
City
Shirvan
Province
North Khorasan
Postal code
9461765871
Phone
+98 58 3622 4373
Email
fooladzadeh8343@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mozhdeh Navidhamidi
Street address
Tohid Square, Dr Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 0000
Email
fooladzadeh8343@gmail.com
Web page address
http://fnm.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohsen Fooladzadeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7, Forth Alley, Forughi Ave
City
Shirvan
Province
North Khorasan
Postal code
9461765871
Phone
+98 58 3622 4373
Email
fooladzadeh8343@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mozhdeh Navidhamidi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4325
Email
navidhamidi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohsen Fooladzadeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
no. 7, forth Alley, Forughi Ave
City
Shirvan
Province
North Khorasan
Postal code
9461765871
Phone
+98 58 3622 4373
Email
mohsen.antisemitism12@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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Educational content will be provided to patients in the form of a booklet
When the data will become available and for how long
From the beginning of the study, the intervention group will be delivered the educational booklet and the control group will be delivered the educational booklet after completing the study.
To whom data/document is available
Intervention group and control group will be delivered the educational booklet.
Under which criteria data/document could be used
After publishing an article, it is possible to use the results for further research.
From where data/document is obtainable
Tehran University of Medical Sciences, Faculty of Nursing and Midwifery
What processes are involved for a request to access data/document
The applicant can receive the documentation after calling the listed phone number.