Protocol summary

Study aim
Determining the effect of safety pad tool on the incidence of needle stick in staff working in Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran
Design
One-group quasi-experimental study, without blinding, non-random and on 387 subjects
Settings and conduct
The research tool, which includes two questionnaires of demographic information and information about Needle Stick, will be provided to nurses and nurse assistances and also by referring to the Infection Prevention and Control Department, the necessary information will be obtained in the last six months. Then, by teaching the personnel participating in the study how to use the safe pad tool, the safe pad will be used for six months. Finally, after a six-month period of using the Safe Pad tool, the use of the needle stick during the six months will be reviewed and compared with the six-month period before using the tool.
Participants/Inclusion and exclusion criteria
Inclusion criteria: nurses and nurse assistances with at least six months of work experience. Exclusion criteria: health care workers who do not used safe pad tool at six consecutive month.
Intervention groups
In this study, a patented safe pad tool is used to prevent needle sticks among hospital staff for six months, and after using it for six months, it is compared with the six-month period before using the tool.
Main outcome variables
Incidence of needle stick in hospital staff

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220316054307N1
Registration date: 2022-04-11, 1401/01/22
Registration timing: prospective

Last update: 2022-04-11, 1401/01/22
Update count: 0
Registration date
2022-04-11, 1401/01/22
Registrant information
Name
Nima yadollahzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3262 3308
Email address
n.yadollahzade@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Using a Safe Pad Tool on The Incidence of Needle Stick in Health Care Workers
Public title
The Effect of Using a Safe Pad Tool on The Incidence of Needle Stick in Health Care Workers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses and Nurse Assistance with work experience of at least six months prior to using the Safe Pad tool Study tools were used in the bed for six months by the subjects to enter the third stage
Exclusion criteria:
Do not use the safe pad tool for six consecutive months People who are transferred to the part where the tool is not used during the six-month period of using the Safe Pad tool.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 387
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
Street address
Schools of Pharmacy, Nursing and Midwifery, Shahid Beheshti University of Medical Sciences,. Valiasr St., Niayesh Highway Junc,
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-03-15, 1400/12/24
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.332

Health conditions studied

1

Description of health condition studied
صدمات ناشی از نیدل استیک
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The Incidence of Needle Stick
Timepoint
Measure the incidence of needle stick six months before the intervention and six months after the intervention
Method of measurement
Demographic Information Questionnaire and Needle Stick Information

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first stage, the questionnaire tool, which includes two sections of demographic information and information about Needle Stick, will be provided to nurses and nurse assistance Also, by referring to the Infection Prevention and Control Department, the necessary information is obtained in a period of six months. In the second stage, by teaching how to use the Safe Pad tool, by installing educational posters on how to use the Safe Pad tool in the wards, as well as teaching face to face to the wards head nurses, the Safe Pad tool will be used for six months. The invented Safe Pad tool is a plexiglass cube in which there are a 40 kg/m3 density sponge and a double-sided glue inside and bottom side of that, respectively which the nurse can insert into a kidney dish or tray and take to the patient side. The two sides of this cube are open and in the time of vein puncturing, the needle taken out of the angiocath is inserted into the sponge with only one hand. By using this small tool, hospital clinical staff remove all kinds of sharp tools such as angiocath, needles, syringes, suture needles, and scalpels immediately, then after filling the sponge with the needles, the sponge is removed from the cube with a special clip and can be placed in the safety box.Finally, in the third stage, after six months of using the safe pad tool, a two-part questionnaire is given to the participants again and by referring to the Infection Prevention and Control Department, the necessary information is obtained during the use of the tool. And will be compared with the time period of six months before using the tool.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Alireza Manafi Rathi
Street address
Imam Hossein Sq., Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2416
Email
info@ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
دکتر افشین زرقی
Street address
Shahid Beheshti University of Medical Sciences,. Taleghani Hospital Near,. Shahid Arabi St,. Yemen St,. Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima yadollahzade
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 608, Goolbagh1st Alley., Ahangarkolaye bozorg Village., Shahid Salehi Ave
City
Babol
Province
Mazandaran
Postal code
4734116194
Phone
+98 11 3262 3308
Email
yadollahzade.nima1998@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra zandi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr St., Niayesh Highway Junc.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5363
Email
mitra.zandi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima yadollahzade
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 608, Goolbagh1st Alley., Ahangarkolaye bozorg Village., Shahid Salehi Ave
City
Babol
Province
Mazandaran
Postal code
4734116194
Phone
+98 11 3262 3308
Email
yadollahzade.nima1998@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
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