Determining the effect of using local finger cold on the pain caused by the glucometer needle, blood sugar level and satisfaction of patients with diabetes.
Design
A controlled, parallel-group, unblinded, non-randomized, phase 2 clinical trial on 40 patients.
Settings and conduct
Patients with type 2 diabetes admitted to hospitals affiliated to Shahid Beheshti University of Medical Sciences, where the finger of one hand of each patient is considered as the intervention group and the finger of the other hand as the control group and without blinding have been.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients with type 2 diabetes; full consciousness; familiarity with the Persian language; lack of sensory and mental disorders; No treatment with sedatives
Exit criteria:
having any pain; lack of cooperation and consent; sensitivity to karyotherapy; having a skin wound at the cryotherapy site; presence of peripheral neuropathy; Use of painkillers in the previous 24 hours
Intervention groups
In the intervention group, first, a cube-shaped piece of ice was placed in a nylon freezer and placed on the desired finger for the needle to enter, and the patient was asked to rub for 30-45 seconds before the needle was inserted. Then the needle was inserted and immediately the pain level of the patients was checked. A needle was placed on the finger of the other hand without cryotherapy, and the patient's pain and blood sugar levels were immediately recorded.
Main outcome variables
The level of blood sugar, the level of pain caused by the glucometer needle, the level of satisfaction of patients with type 2 diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230724058906N1
Registration date:2023-09-02, 1402/06/11
Registration timing:retrospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Zahra Khorrami khorram abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 697 0429
Email address
zahrakhorrami77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
2023-01-05, 1401/10/15
Actual recruitment end date
2023-02-04, 1401/11/15
Trial completion date
2023-02-04, 1401/11/15
Scientific title
The Effect of using Local Finger Cold on Pain caused by Glucometer Needle, Blood Glucose Concentration and Satisfaction in Patients with Diabetes
Public title
The Effect of Cryotherapy on Pain Caused by Glucometer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes who are confirmed by a specialist doctor
Full alertness
Familiarity with Persian language
Absence of vision and hearing impairment and active mental illness
No treatment with sedatives (according to the patient himself) and painkillers in the last 24 hours
Exclusion criteria:
Having any noticeable pain before the needle is inserted
Having obvious behavioral problems or lack of cooperation and consent to carry out interventions
The presence of any sensitivity to cryotherapy or those suffering from Raynaud's syndrome or sickle cell anemia
Having a skin wound at the cryotherapy site
Absence of peripheral neuropathy in patients
History of using painkillers, anesthesia and lidocaine and similar compounds in the previous 24 hours
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Examining the blood sugar and the amount of pain caused by the glucometer needle in the finger of two different hands of the patient, and the finger of one hand as the intervention group and the finger of the other hand as the control group.
Actual sample size reached:
40
More than 1 sample in each individual
Actual sample size in each individual:
2
Examining the blood sugar and the amount of pain caused by the glucometer needle in the finger of two different hands of the patient, and the finger of one hand as the intervention group and the finger of the other hand as the control group.
Randomization (investigator's opinion)
N/A
Randomization description
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 Shahid Beheshti University of Medical Sciences
Street address
Ethics committee of Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr St., intersection of Ayat Ah... Hashemi Rafsanjani Highway, in front of Shahid Rajaee Heart Hospital.
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2022-09-06, 1401/06/15
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.124
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
The pain score caused by the glucometer needle with a visual scale
Timepoint
Before and after cryotherapy
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Amount of pain and blood sugar level based on the number displayed by the glucometer.
Timepoint
Before and after cryotherapy
Method of measurement
The number displayed by the glucometer.
Intervention groups
1
Description
Intervention group: In the cryotherapy method, first, a cube-shaped piece of ice is placed in a nylon freezer and placed on the desired finger for the needle to enter, and the patient is asked to rub the said place for 30 seconds before the needle enters. Then, the entry site is well disinfected and the needle is inserted, and the pain level of the patients is immediately assessed using the visual pain criterion.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish hospital
Full name of responsible person
Zahra Khorrami khorram abadi
Street address
Shohadaye Tajrish Educational Medical Center, Shahadari St., Tajrish Square.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
pr-shohada@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Imam Hussein hospital
Full name of responsible person
Zahra Khorrami khorram abadi
Street address
Imam Hossein Medical Research Training Center, Shahid Madani St.
Vice President of Research and Technology of Shahid Beheshti University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Street, Niayesh highway cross,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
zahrakhorrami77@gmail.com
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
Zahra Khorrami khorram abadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences, Valiasr Street, Niayesh highway cross
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
zahrakhorrami77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Khorrami khorram abadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences, Valiasr Street, Niayesh highway cross
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
zahrakhorrami77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Khorrami khorram abadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences, Valiasr Street, Niayesh highway cross,Tehran,
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
zahrakhorrami77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The individual data of the participants and the informed consent form in the study can be shared after de-identification.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
All those interested in the field of medical sciences and pain control in patients with diabetes
Under which criteria data/document could be used
The use and analysis of the data of this study is allowed if it is done ethically, and people can request the use of the data by sending an email or a letter to the responsible author.
From where data/document is obtainable
Zahra Khorrami
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Street, Niayesh highway cross,Tehran, Iran.
Tel: 09136970429
Email: zahrakhorrami77@gmail.com
What processes are involved for a request to access data/document
The applicant can request the use of the information by sending an email to the responsible author at zahrakhorrami77@gmail.com and I will provide the information to the applicant for a maximum of 7 working days after receiving the email.