Determining The Effect of Patient Preparation by Multimedia Method on Anxiety,Pain,and Consumption of analgesic after Vitrectomy
Design
Clinical trail with control group with non-parallel groups, double blind, randomized block, with evaluation of results
Settings and conduct
The information is collected by researcher assistant. In order to blind the study, the researcher assistants and statistical advisers are not informed about the allocation of patients in the control or intervention groups.
The method of conducting the research: clinical trial
research implementation environment: Khalili Hospital of Shiraz
Case study: Patients who are the candidates of vitrectomy surgery in Khalili Hospital
Participants/Inclusion and exclusion criteria
Entry Requirements:
People's willingness to participate in the study
Range of ages 18 to 70 years
Admission for at least 1 day before surgery;
Lack of mental illness;
No contraindication for using non-steroidal anti-inflammatory drugs and analgesics
No drug addiction
The patient has the ability to see and hear
Patients who are candidates for retinal detachment have a vitrectomy in one eye.
The patient should be placed in the group "l" or "ll" according to the physical state of the ASA
Exit Conditions Study:
Failure to speak
Non-Iranian nationality
Any factor that causes the patient to be unavailable after the operation
Intervention groups
Intervention:Preparation of didactic videos and photographs about the environment of the operative room, type of surgery, presurgery and postsurgery conditions, type of anesthesia, training of pain control without medication, and also oral explanation to the question.
study group's patients who receive multimedia training. The control group includes the people who receive routine care.
Main outcome variables
preoperative anxiety and postoperative pain and consumption of analgesic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180603039968N1
Registration date:2018-10-10, 1397/07/18
Registration timing:registered_while_recruiting
Last update:2018-10-10, 1397/07/18
Update count:0
Registration date
2018-10-10, 1397/07/18
Registrant information
Name
Esmaeil Kargar doulat abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3726 1158
Email address
kargarda@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Patient Preparation by Multimedia Method on Anxiety, Pain, and Consumption of analgesic after Vitrectomy surgery.
Public title
The Effect of Patient Preparation by Multimedia Method on Anxiety, Pain, and Consumption of analgesic after Vitrectomy surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People's willingness to participate in the study
Age range of 18 years old to 70 years old
Hospitalization for at least 1 day before surgery
No history of mental illness
No prohibition of non-steroidal anti-inflammatory drugs and analgesics
No addiction to drugs
The patient should have the ability of seeing and hearing
Patients who are candidates for single-eye vitrectomy surgery because of retinal detachment
The patients will be placed in group I or group II according to the physical state of ASA
Exclusion criteria:
Inability to speak
Non-Iranian nationality
Any factor that leads the patient to become unresponsive after surgery
Having the history of attending anxiety control and problem-solving training classes
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
120
More than 1 sample in each individual
Number of samples in each individual:
3
Anxiety, Pain, and Consumption of analgesic
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block
Each block represents a week.
Each block size is equivalent to 4 days of a week when vitrectomy surgeries are conducted.
The days when the vitrectomy surgery is conducted:Sunday, Monday, Tuesday and Thursday
In this method, the study group is named as group A and the control group is named as group B.
According to the existing conditions, 6 blocks are likely to be as follows:
1-AABB
2- ABAB
3 ABBA
4- BBAA
5- BAAB
6- BABA
Selection of blocks is random and based on the cards' shuffling.
By selecting each card, the samples are respectively placed in the control or study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
• In order to blindness in the study, researchers and statistical advisers will be unaware of the allocation of patients in the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Street Karim Khan Zand; Shiraz University of Medical Sciences
The night before the operation and 30 minutes before entering the operating room
Method of measurement
Spielberger questionnaire
2
Description
pain
Timepoint
In the recovery room before entering the department; 1,2,3,4 hours after entering the department
Method of measurement
VAS
3
Description
consumption of analgesics
Timepoint
In the recovery room before entering the department; 1,2,3,4 hours after entering the department
Method of measurement
mg
Secondary outcomes
empty
Intervention groups
1
Description
Study group: After selecting the block, the allocation of patients to the study group is determined. On the night before the surgery, by considering the entry requirements of the study, and after having effective communication and gaining patient's trust, we will start to explain the process to the patient, gain his/her satisfaction and describe the research goals. Patient information is also recorded and the Spielberger questionnaire is filled in. Patients receive routine medical and nursing care according to the hospital policies. Afterward, some didactic photographs and videos will be shown to the patient by using a tablet, and his/her oral questions will be answered. The investigator explains to the patient about non-pharmacological pain control methods as the complementary of pharmacological therapies. In the next step, 30 minutes before entering the operating room, patient's information is recorded and the Spielberger questionnaire is filled in. All patients undergo the general anesthesia. After surgery, at intervals before entering the department, and 1, 2, 3, and 4 hours after entering the department, the level of pain and consumption of pain killers will be measured.
Category
N/A
2
Description
Control group: After selecting the block, the allocation of patients to the control group will be determined. On the night before the operation, by considering the entry requirements of the study, after describing the process and gaining satisfaction of the patient, the patient's information will be recorded and the Spielberger questionnaire will be filled in. the control group's patients will receive routine medical and nursing care according to hospital policies. In the next step, 30 minutes before entering the operating room, patient's information is recorded and the Spielberger questionnaire is filled in. All patients undergo the general anesthesia. After surgery, at intervals before entering the department, and 1, 2, 3, and 4 hours after entering the department, the level of pain and consumption of pain killers will be measured.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili hospital
Full name of responsible person
Esmaeil Kargar
Street address
Shiraz, Kalili Street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1470
Email
Esmaeil.kargarda@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Molazem
Street address
Shiraz, Karim Khan Zand St., Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3235 7282
Email
Molazemzah@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Esmaeil Kargar
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz - Khalili Street Khalili Hospital
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3629 1470
Email
esmaeil.kargarda@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Esmaeil Kargar
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz - Khalili Street Khalili Hospital
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3629 1470
Email
Esmaeil.kargarda@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Esmaeil Kargar
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz - Khalili Street Khalili Hospital
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3629 1470
Email
Esmaeil.kargarda@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
Mean of anxiety score, mean of pain anxiety score, mean of blood pressure, mean of consumption of analgesic
When the data will become available and for how long
6 months after printing results
To whom data/document is available
All people
Under which criteria data/document could be used
If allowed, Shiraz University of Medical Sciences and authors are allowed to access
From where data/document is obtainable
esmaeil Kargar. Contact number: 00989380676316
esmaeil.kargarda@gmail.com
Zahra molazem Associate Professor of Fatemeh Nursing and Midwifery Faculty
molazemzah@yahoo.com
What processes are involved for a request to access data/document