Determining the effect of self-care education with tele-nursing approach on anxiety and quality of life in patients with diabetic retinopathy treated with Austin
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized by random permutation block method, without phase and on 76 patients.Www.sealedenvelope.com was used for randomization.
Settings and conduct
The researcher will go to the clinic of Khatam al-Anbia Hospital and then according to the entry criteria, she will start selecting the data and introduce the research and obtain informed consent and proceed to complete the demographic information, anxiety and quality of life questionnaire.From the time of the first meeting to the day of injection, the researcher sends the files to the intervention group via WhatsAppOn the morning of the injection, the anxiety questionnaire is completed again.From the first injection to the second injection for 4 weeks, sending educational files continues.On the morning of the second injection, the anxiety questionnaire is completed for the third time.And sending files will continue for another month. After 2 months, the quality of life and anxiety questionnaire will be completed again.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Diagnosis of diabetic retinopathy
Diagnosis of a candidate for Avastin
Having a smart phone
Having adequate hearing
Have a minimum literacy
No other eye diseases
No history of psychological illness
Satisfaction with participation
Infection with other diseases that lead to hospitalization
Perform surgery while studying
Non-entry criteria:
Having a history of Avastin injection
Intervention groups
For the intervention group, related trainings are sent by sending audio and video files twice a week for two months and the control group receives routine care.
Main outcome variables
Anxiety; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220611055134N1
Registration date:2022-07-12, 1401/04/21
Registration timing:prospective
Last update:2022-07-12, 1401/04/21
Update count:0
Registration date
2022-07-12, 1401/04/21
Registrant information
Name
Elaheh Keshavarzian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3821 1523
Email address
keshavarziane981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-21, 1401/04/30
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tele-nursing self-care training on anxiety and quality of life in Avestin-treated Diabetic retinopathy patients
Public title
The effect of tele-nursing self-care training on anxiety and quality of life in Avestin-treated patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of diabetic retinopathy by a doctor
Diagnosis of a candidate for Avastin by a doctor
Having a smart phone
Having enough hearing
Having a minimum literacy
Lack of other eye diseases
No history of psychological illness
Satisfaction for participation
Exclusion criteria:
Having previous experience of injecting Avastin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is block type.To ensure an equal number of people in the study, a randomized permutation block method will be used in both groups.For this purpose, we will use the www.sealedenvelope.com website. in this way, 19 blocks of 4 members are randomly created through the site.The researcher assigns the sample to the groups. By listing the patients selected based on the inclusion criteria by the doctor, the researcher first groups the samples and then meets with the patients.
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 Mashhad University of Medical Sciences
Street address
Ebne sina avenue-school of nursing and midwiferry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177164383
Approval date
2022-06-07, 1401/03/17
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.024
Health conditions studied
1
Description of health condition studied
Diabetic retinopathy
ICD-10 code
E08.31
ICD-10 code description
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy
Primary outcomes
1
Description
Anxiety score in Spielberger overt and covert anxiety questionnaire
Timepoint
Anxiety will be measured before the intervention ,before the first injection , before the second injection and after the intervention.
Method of measurement
Spielberger overt and covert anxiety questionnaire
2
Description
quality of life measuring with SF36 quality of life questionnaire
Timepoint
before the intervention and two months after the quality of life of patients will be measured
Method of measurement
Sf 36 questionnaire will be used to measure the quality of life of patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first stage of the researcher's face-to-face meeting with the patient, the researcher completes the demographic information questionnaire, quality of life questionnaires and overt and covert Spielberger questionnaire as a pre-test with the patient's help.From the time of the first appointment to the day of the Austin drug injection (one day later), the researcher sends short audio and video files of 3-4 minutes through the WhatsApp application, which includes pre-injection care and how to inject, as a personal message to The patient sends.In the morning of the injection, the anxiety questionnaire is completed for the second time. The patient is then injected by the doctor and as soon as he/she is discharged from the Austin drug injection unit, a file containing post-injection care, symptoms and complications of the injection is sent to the patient.From the day after the day of the injection until the night of the second injection for four weeks (intervals between each injection is one month) files containing how to measure and control blood sugar, importance and how to fill the blood sugar chart, importance and how to control diet, activity and Exercise is sent twice a week in a personal message (pv) and each time after receiving feedback from the patient.The night before the second injection (one month later), the files related to the injection (pre-injection care and injection method) are sent to the patient again. On the morning of the second injection (before the injection), the patient completes the anxiety questionnaire for the third time. After the injection, the patient is discharged from the Austin drug injection unit and the audio and video files continue to be sent for another month. After two months before the doctor's visit, the quality of life and anxiety questionnaire will be checked.Each time the files are sent, if a question arises for the patient, the question is first raised with the professors in the research and after receiving an answer from them, the answer is sent to the patient.
Category
Rehabilitation
2
Description
Control group: During the intervention, the control group will receive the routine care of the hospital, such as educational pamphlets available in the hospital, and after completing the study, they will receive all audio and video files and pamphlets prepared from the intervention product.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Khatam Al-Nabia Hospital in Mashhad
Full name of responsible person
Nahid Aghebati
Street address
Doctora Blvd.,Mashhad School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1512
Email
keshavarziane981@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Street address
Doctora Blvd.,Mashhad School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
aghebatin@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 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
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Position
associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Aghebatin@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
aghebatin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
aghebetin@mums.ac.ir
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
The plan in this study is to publish the final report in the form of an article and a senior thesis.
When the data will become available and for how long
Probably, the results of this study will be published and made available to the public in the next two years.
To whom data/document is available
All researchers working in different institutions
Under which criteria data/document could be used
All researchers who intend to conduct meta-analysis and systematic review studies in the future can use the results of this study. Also, they can request more data in this field from researchers.
From where data/document is obtainable
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
Postal code: 9137913199
Fax: 051 38597313
Phone: 051-38591511-3
Email: nms.pr@mums.ac.ir / aghebatin@mums.ac.ir / keshavarziane981@mums.ac.ir
Respondents: Nahid Aghebati / Elaheh Keshavarzian / Mashhad College of Nursing and Midwifery Library
What processes are involved for a request to access data/document