The effect of the stress ball on the anxiety in patients undergoing coronary angiography
Design
The double blinded clinical trial study includes intervention and control groups. Each group consists of 40 people. The randomization will be done lottery by even and odd day.
Settings and conduct
Study in Mazandaran heart center by identifying angiography patients, intervention group and control group will be selected by lottery method on even and odd days. The reason for double blind is that the participant and the researcher are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Full oriented, over 18 years old, not having a known psychology disorder, not taking anti-anxiety drugs, not being addicted to opioids or narcotic analgesic, angiography candidate, first time angiography, angiography through the femoral artery.
Intervention groups
The stress ball is provided to the patient and it will be explained to the patient that this is to relieve the feeling of anxiety and disperse the thoughts of fear and anxiety caused by the angiography process. It will be explained how to use the ball.
In the control group, routine care will be done by the ward personnel, both intervention and control groups will receive routine care.
Main outcome variables
Reducing the intensity of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150916024047N7
Registration date:2024-01-14, 1402/10/24
Registration timing:prospective
Last update:2024-01-14, 1402/10/24
Update count:0
Registration date
2024-01-14, 1402/10/24
Registrant information
Name
Hedayat Jafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 7268
Email address
hjafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of stress ball on anxiety in patients under coronary artery angiography
Public title
The effect of stress ball on anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness
Age over 18 years
Angiography for the first time
Angiography trans femoral
Exclusion criteria:
Taking anti-anxiety drugs
Having known psychiatric disorder
Addiction to opioids or analgesics
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
To conduct the research, by referring to the Mazandaran heart center and identifying the angiography patients, the people of the test and selection group will be selected on even and odd days, and each group will be placed on the same day, and to determine which group of patients will be on even or odd days. It defines the person. The lottery method is used to place the individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants were blinded in such a way that each of the intervention and control groups were placed on different days (even and odd) randomly and each group did not know about the implementation of the other group's intervention.
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
Moalem street, Moalem sqaure, Sari
City
Sari
Province
Mazandaran
Postal code
4815696869
Approval date
2023-12-09, 1402/09/18
Ethics committee reference number
IR.MAZUMS.REC.1402.515
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and 30 minutes after the intervention
Method of measurement
Spielberger Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The stress ball is available to the patient during angiography. The stress ball is completely soft and has dimensions of 7*7*7 and it is made of jelly that squeezes small bubbles out of the net cover. This ball is available in different and beautiful colors and seven colors, which makes the appearance of these balls attractive. In the current intervention, the ball will be made from the brand Meshball, which has good quality and will not tear when squeezed by the patients.
Category
Treatment - Devices
2
Description
Control group: No intervention will be done for the control group by the researcher.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran heart center
Full name of responsible person
Hedayat jafari
Street address
Next to Blood Transfusion Organization, Army Blvd., Imam Hossein Square., Sari., Mazandaran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۸۸۱۳۳۷۱
Phone
+98 11 3332 3023
Fax
+98 31 1332 3023
Email
hedayat2003@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Vice Chancellor for Research Mazandaran University of Medical Sciences, Moalem St., Moalem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3448 4851
Email
pajhooheshi@mazums.ac.ir
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
Dr. Hedayat Jafari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences Faculty of Nursing and Midwifery, Vasal St., Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815696869
Phone
+98 11 3336 7344
Email
hedayat2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Hedayat Jafari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences Faculty of Nursing and Midwifery, Vasal St., Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3379 5555
Email
hedayat2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Elahe Arabameri
Position
Master Student Of Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences Faculty of Nursing and Midwifery, Vasal St., Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 4750
Email
amerii.elaheh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
If the names of the people are not identifiable and only the main consequences
When the data will become available and for how long
At the end of the study
To whom data/document is available
For researchers working in Academic And Scientific institutions
Under which criteria data/document could be used
For researchers working in Academic And Scientific institutions
From where data/document is obtainable
hedayat2003@yahoo.com
What processes are involved for a request to access data/document
Due to the privacy of the research participants, the data generated during the current study are not publicly available, but are available via Dr. Hedayat Jafari upon reasonable request (hedayat2003@yahoo.com). The Email will be response up to 7 days