Effect of Coughing Technique, ShotBlocker, and Vibration on Pain and Satisfaction During Subcutaneous Insulin Injections for Adults Patients with Type 2 Diabetes mellitus: A Randomized Controlled Trial
To assess the effect of the coughing technique and shot blocker and vibration on the intensity of pain and the degree of patient satisfaction during the administration of subcutaneous insulin injection.
Design
quantitative research a true experimental a posttest-only.
Settings and conduct
Imam Al-Hassan Teaching Hospital, Al-Hindia Teaching Hospital, and Imam Al-Hussein Medical City. facilitate a comprehensive examination of both logistical factors and participant accessibility.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: aged 18 years or older, must not have administered any analgesic medications for a minimum duration of 8 hours prior
Exclusion Criteria: diagnosed with Type 2 diabetes for 10 years or more,suffered trauma near the injection site
Intervention groups
White for the control cohort, Yellow for the coughing technique
, Blue for the ShotBlocker device exclusively, and Green for vibration exclusively. Subsequently, To execute the Coughing Technique: will be instructed to inhale deeply and perform a single cough. Following a 10-second interval, During the second coughing action, the needle will be introduced into the tissue,
In ShotBlocker Device: The ShotBlocker apparatus shall be affixed to the dermal surface at the designated injection locus prior to the insertion of the needle. The injection procedure will transpire through the aperture present in the device, Vibration will be administered to the cutaneous surface
2 to 3 seconds preceding the insertion of the needle.
Main outcome variables
Reducing Pain and increased satisfaction Insulin Injections
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241103063580N1
Registration date:2024-12-02, 1403/09/12
Registration timing:registered_while_recruiting
Last update:2024-12-02, 1403/09/12
Update count:0
Registration date
2024-12-02, 1403/09/12
Registrant information
Name
Ali DHAHIR Abdulyemmah
Name of organization / entity
University of baghdad
Country
Iraq
Phone
+964 771 591 5517
Email address
ali.abd2302m@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-01, 1403/09/11
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Coughing Technique, ShotBlocker, and Vibration on Pain and Satisfaction During Subcutaneous Insulin Injections for Adults Patients with Type 2 Diabetes mellitus: A Randomized Controlled Trial
Public title
Effect of Coughing Technique, ShotBlocker, and Vibration on Pain and Satisfaction During Subcutaneous Insulin Injections for Adults Patients with Type 2 Diabetes mellitus: A Randomized Controlled Trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Participants must be adults diagnosed with Type 2 diabetes currently hospitalized
Aged 18 years or older
Alert, and capable of providing informed consent
Participants should demonstrate the ability to comprehend and adhere to verbal instructions
Be undergoing regular subcutaneous insulin injections
Not have administered any analgesic medications for a minimum duration of 8 hours prior to the injection.
Exclusion criteria:
Patients diagnosed with Type 2 diabetes for a duration of 10 years or more
Suffered trauma near the injection site
Patients exhibiting cognitive impairments or mental health disorders that hinder their capacity to understand or provide consent
Patients presenting with active infections or complications at the injection site
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be identified through the use of
color-coded cards: green indicating eligibility and red denoting ineligibility. Those possessing the eligible
card will select from one of four distinct colored cards, each symbolizing a unique intervention condition:
White for the control cohort, Yellow for the coughing technique exclusively, Blue for the ShotBlocker
device exclusively, and Green for vibration .
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 in College of Nursing at University of Baghdad
Street address
Bab-AlMuadham
City
Baghdad
Postal code
10047
Approval date
2024-10-28, 1403/08/07
Ethics committee reference number
6
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
The primary outcome variable is the level of pain that can be changed. based on Vibration or coughing technique or ShotBlocke
Timepoint
for 2-3 seconds before needle insertion. immediately after subcutaneous insulin injection when using the ShotBlocker, vibration device, and coughing technique. The level of pain will be measured
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
The secondary outcome variable is the level of patient satisfaction that can be changed based on vibration device or coughing techniqe or shotblocker
Timepoint
for 2-3 seconds before needle insertion. immediately after subcutaneous insulin injection when using the ShotBlocker, vibration device, and coughing technique.the level of satisfaction will be measured
Method of measurement
Visual Individual Satisfaction Scale (VISS)
Intervention groups
1
Description
Intervention group: Those possessing the eligible card will select from one of four distinct colored cards, each symbolizing a unique intervention condition: Yellow for the coughing technique exclusively, Blue for the ShotBlocker device exclusively, and Green for vibration exclusively. Subsequently, each participant will receive the intervention corresponding to their selected card.
Category
Other
2
Description
Control group: For the control group, no interventions will be done, White card for the control cohort the pain and patient satisfaction will assess immediately after insulin injection
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
karbala Health Department / Al- Imam Al-Hussein city
Full name of responsible person
Ali DHAHIR Abdul yemmah
Street address
Karbala
City
Karbala
Postal code
56001
Phone
+964 1 415 0076
Email
ali.abd2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
2
Recruitment center
Name of recruitment center
Karbala Health Department/ Al-Hindia Teaching Hospital
Full name of responsible person
Ali DHAHIR Abdul yemmah
Street address
Karbala
City
Karbala
Postal code
56001
Phone
+964 1 415 0076
Email
ali.abd2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
3
Recruitment center
Name of recruitment center
karbala Health Department /Imam Hassan Al Mujtaba Teaching Hospital.
Full name of responsible person
Ali DHAHIR Abdul yemmah
Street address
karbala
City
karbala
Postal code
56001
Phone
+964 1 415 0076
Email
ali.abd2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
4
Recruitment center
Name of recruitment center
Babylon Health Department / Imam Al-Sadiq Teaching Hospital
Full name of responsible person
Ali DHAHIR Abdul yemmah
Street address
Al Hilla
City
Al Hilla
Postal code
51001
Phone
+964 1 415 0076
Email
ali.abd2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of nursing ,University of Baghdad
Full name of responsible person
Assist professor, PhD,Haider Mohammed Majeed
Street address
Bab-AlMuadham
City
Baghdad
Postal code
10047
Phone
+964 1 415 0076
Email
ali.abd2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
College of nursing,University of Baghdad
Full name of responsible person
Ali DHAHIR Abdul yemmah
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Adult nursing
Street address
karbala
City
karbala
Province
karbala
Postal code
56001
Phone
+964 1 415 0076
Email
ali.abd2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of nursing,University of Baghdad
Full name of responsible person
Ali DHAHIR Abdul yemmah
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Adult nursing
Street address
Karbala
City
Karbala
Province
Karbala
Postal code
56001
Phone
+964 1 415 0076
Email
ali.abd2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Person responsible for updating data
Contact
Name of organization / entity
College of nursing, University of Baghdad
Full name of responsible person
Ali DHAHIR Abdul yemmah
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Adult nursing
Street address
Karbala
City
Karbala
Province
Karbala
Postal code
56001
Phone
+964 1 415 0076
Email
ali.abd2302m@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
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 researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution.
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: ali.abd2302m@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.