Determining the mean score of anxiety in patients who are candidates for spine surgery before and after the training video and the control group.
Design
The parallel clinical trial with control and intervention groups. Single-blind with a random assignment performed on 90 patients (45 people in each group). The permuted block method is used for randomization.
Settings and conduct
Patients who are candidates for spine surgery (including CD insertion, discectomy and stenosis) referred to Peymaniyeh hospital in Jahrom. The control and intervention groups have one week different in terms of sampling.
Participants/Inclusion and exclusion criteria
fully conscious, ability to communicate and speak, with informed consent to participate in the study, no vision problems, no history of mental illness or severe stressors in the last 6 months, no illness Background such as skin disease and diabetes.
Exclusion criteria: dissatisfaction to participate in the study or death of the patient.
Intervention groups
In the control group, we will teach through videos the night before the operation. We will not have a training for the control group and only routine trainings will be explained by the nurse.
Main outcome variables
The effect of educational video on the level of knowledge, quality of wound care of patients, surgical anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210306050602N1
Registration date:2021-07-18, 1400/04/27
Registration timing:retrospective
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
zohre Khodadadi jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5422 8202
Email address
khodadadist1393@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-13, 1400/01/24
Expected recruitment end date
2021-05-04, 1400/02/14
Actual recruitment start date
2021-04-12, 1400/01/23
Actual recruitment end date
2021-06-19, 1400/03/29
Trial completion date
2021-06-19, 1400/03/29
Scientific title
The effect of designed educational video on the level of anxiety and quality of wound care in patients undergoing spinal surgery
Public title
The effect of designed educational video on the level of anxiety and quality of wound care in patients undergoing spinal surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient should be fully conscious.
Be able to communicate and speak.
Have informed consent to participate in the study.
Do not have vision problems.
Have no history of mental illness or severe stressors in the past 6 months.
No underlying diseases such as skin diseases and diabetes
Exclusion criteria:
Dissatisfaction with participating in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
To assign the samples to the intervention and control group, using the Block Randomization method, we make four blocks from the letters A and C, which determine the six AACC-ACCA-CCAA-CAAC-CACA-ACAC blocks from 1 to 6, and Randomly using the table of random numbers to determine 88 patients, the names of the groups are determined, but its list is determined, and according to the continuous referral of patients based on the determined list, which is kept in the hands of the main executor. By preparing 88 envelopes, the patient's reference number is specified on the envelope and the type of intervention or control inside the envelope, and after each patient's visit, the type of intervention or control is determined by opening the envelope and the necessary action is taken for each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Health care providers, such as nurses, will not be informed about the content and method of training and will berequested to provide all routine trainings to all patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Sari, Joibar intersection, at the beginning of Vali-e-Asr Highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.MAZUMS.REC.1400.023
Health conditions studied
1
Description of health condition studied
Candidates for spine surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
The night before surgery and in the morning of surgery
Method of measurement
Using the Spielberger Anxiety Inventory
2
Description
Awareness
Timepoint
Before and after the training video
Method of measurement
Using a researcher-made questionnaire
3
Description
Quality of surgical wound care
Timepoint
48 hours and two weeks after surgery
Method of measurement
Using the checklist and view
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, we will train the night before the surgery and fill in the anxiety questionnaire the night before the operation. In the morning of the operation, the questionnaire will be filled in again. In 48 and two weeks after the operation, we will examine the quality of wound care. We will check the level of awareness before and after the training.
Category
Other
2
Description
Control group: We will not intervene for the control group, we will only fill in the anxiety and awareness questionnaire and check the quality of wound care in 48 hours and two weeks after the operation.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom Peymanieh Hospital
Full name of responsible person
Zohre Khodadadi Jahromi
Street address
Red Crescent Street Alley 24
City
Jahrom
Province
Fars
Postal code
7413717969
Phone
+98 71 5422 8202
Email
khodadadist1393@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saidi
Street address
Sari, Joibar intersection, at the beginning of Vali-e-Asr Highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4800
Fax
+98 11 3326 1244
Email
majsaeedi@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Zohre Kodadadi Jahromi
Position
Senior student in the operating room of Mazandaran University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Red Crescent Street Alley 24
City
Jahrom
Province
Fars
Postal code
7413717969
Phone
+98 71 5422 8202
Email
khodadadist1393@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohre Khodadadi Jahromi
Position
Senior student in the operating room of Mazandaran University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Red Crescent Street Alley 24
City
Jahrom
Province
Fars
Postal code
7413717969
Phone
+98 71 5422 8202
Email
khodadadist1393@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohre Khodadadi Jahromi
Position
Senior student in the operating room of Mazandaran University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Red Crescent Street Alley 24
City
Jahrom
Province
Fars
Postal code
7413717969
Phone
071542282202
Email
khodadadist1393@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
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