the effect of educational program based on Newman's systemic model on the anxiety of eye surgery candidates
Design
Clinical trial with control group, with parallel groups, randomized, on 70 patients. Blocking will be used for randomization.
Settings and conduct
After obtaining the necessary permits, the researchers will introduce themselves to the officials of Valiasr hospital (AS) in Zanjan. After explaining the objectives of the study to the participants, they will be assured about the confidentiality of the information and the right to withdraw from the study. Patients are assigned to intervention and control groups by block method.
Participants/Inclusion and exclusion criteria
- Not having psychological diseases according to patients and companions
- Age between 18 and 65 years
- Having consent to study
- Not taking anti-anxiety drugs
- Not being addicted to opioids or narcotic painkillers
- Having surgery in the eye area
Intervention groups
The study will have intervention and control groups. The control group will receive routine ward care. For the intervention group, an educational action based on Betty Newman's systemic nursing model will be carried out. Interventions will be carried out in three levels of primary, secondary and tertiary prevention.
Main outcome variables
The patients' anxiety will be measured before and after the intervention with the standard Spielberger questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230330057785N1
Registration date:2023-04-18, 1402/01/29
Registration timing:prospective
Last update:2023-04-18, 1402/01/29
Update count:0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
ali aghajanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8123
Email address
aghajanloo@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-20, 1402/02/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of educational program based on Newman's systemic model on the anxiety of eye surgery candidates
Public title
The effect of educational program on patients' anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not having psychological diseases
Not taking anti-anxiety drugs
Not being addicted to opioids or narcotic painkillers
Having consent to study
Having surgery in the eye area
Exclusion criteria:
Lack of cooperation or patient satisfaction at any stage of the study
Aggravation of the patient's conditions during the study and the need for advanced interventions
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly divided into two intervention groups or control groups using the block method. For this purpose, with the help of the site www.sealedenvelope.com and by specifying the number of participants, the number of groups, the size of the blocks, the list and the order of the participants will be determined. Then the group list (intervention, control) of the participants will be written in the sealed envelope in order, and after determining the criteria for entering the patients, it will be opened to determine their group.
It is necessary to explain that blocking will be done by someone other than the researcher.
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 Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences , Dr.Sobouti Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.ZUMS.REC.1401.378
Health conditions studied
1
Description of health condition studied
Candidate patients for eye surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
anxiety
Timepoint
Before and after the intervention
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention group: The day before the surgery, the intervention will be performed by the researcher according to Betty Newman's systemic nursing model. The examination tool provided by Betty Newman in this model is related to the totality of the individual and includes the following 3 principles: 1- Full knowledge of the factors that affect the understanding of the patient. 2- Approving and valuing a stressor by the patient and caregiver. 3- Factors that affect the caregiver's mind in examining the patient's condition, In this regard, the researcher identifies the factors affecting their anxiety. In the evaluation stage of Newman's systemic model, first, potential/actual tensions, appropriate goals and strategies for actions will be determined, and then natural and flexible defense lines will be strengthened, in which the penetration of stressful factors into the line will be strengthened. Natural defenses will be prevented and the intensity of the reaction will be reduced. The educational content at the level of first prevention includes: explaining the eye anatomy, the role of proper nutrition in relieving stress and anxiety and creating confidence in the hospital and operating room environment, post-operative care and instructions (how to bathe, the position of the patient while sleeping, and taking medications) Was.In the second level of prevention, the compromised natural and flexible defense lines will be restored. The intervention aimed at strengthening the internal defense lines will be carried out in order to reduce the reaction to stressful factors. Educational content at the level of secondary prevention includes: intervention based on the needs and stress factors diagnosed by the patient and the nurse based on Newman's stress factors:• Intrapersonal (awareness of rehabilitation stage, care at home, awareness of surgery, time to return to the ward, awareness of nutrition therapy)• Interpersonal (explaining hospital treatment methods, psychological support, communicating with patients and providing information about drugs)• It will be extroverted (providing information about insurance and paying expenses, talking to the health department and referring patients to charities, creating a calm environment and reducing noise).In the third level of prevention, the use of public system resources, including internal and external environments, will be maximized. The educational content in the third level of prevention will include: the implementation of Benson's sedation method to improve sedation responses.
Category
Rehabilitation
2
Description
The control group will receive routine ward care
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational & Treatment Center of valiasr
Full name of responsible person
Ali Aghajanloo
Street address
Valiasr hospital, Valiasr square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Email
valiasr@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Zanjan University of Medical Sciences , Azadi Square,
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0651
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Ali Aghajanloo
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr Sobouti (Gavazang) Blvd, Central Campus of Zanjan University of Medical Science,School of Nursing and Midwifery
City
Zajnan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8123
Email
aliaghajanloo2001@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ali Aghajanloo
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr Sobouti (Gavazang) Blvd, Central Campus of Zanjan University of Medical Science,School of Nursing and Midwifery
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 21 3314 8123
Email
aliaghajanloo2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ali Aghajanloo
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr Sobouti (Gavazang) Blvd, Central Campus of Zanjan University of Medical Science,School of Nursing and Midwifery
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8123
Email
aliaghajanloo2001@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available