PainNCT05495542
The Effect of ShotBlocker on Injection Pain
A study testing ShotBlocker in people with Pain and Intramuscular Injection, run by Bornova No. 25 Mevlana Family Health Center at 1 site in Turkey (Türkiye).
Trial summary
Shotblocker is an effective approach to reduce injection pain. Generally, injection pain has been studied in children, but reducing injection pain in adults is an important issue. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Intramuscular Injection
- What is being tested?
- ShotBlocker
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to speak and understand Turkish
- Those who volunteered to participate in the study and received written consent
- 18 years old and over
- Those with tetanus+diphtheria vaccination prescription/demand
- No vision-hearing-speech problems
- No secondary cause of acute pain other than intramuscular injection.
- Pregnant women who do not have a physical disability (burn, absence or amputation of an extremity, contracture, tissue necrosis, etc.) for injection into the deltoid muscle.
Who cannot join
- Pregnant women who cannot speak Turkish
- Younger than 18
- Pregnant women who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does "ShotBlocker" Affect Pain and Satisfaction During Diphtheria-Tetanus Vaccination in Pregnant Women? A Randomized Controlled Trial
Shotblocker is an effective approach to reduce injection pain. Generally, injection pain has been studied in children, but reducing injection pain in adults is an important issue. This study investigates the effect of ShotBlocker on pain and satisfaction levels associated with diphtheria-tetanus vaccination in pregnant women.
The sample of this prospective, single-blind randomized controlled experimental study consists of 146 pregnant women registered to the Family Health Center between October 2018 and June 2019. Women were assigned to ShotBlocker and control groups with 73 women in each group. The women's pulse rate was taken one minute before the injection by the researcher. In the ShotBlocker group was used ShotBlocker. The control group used the steps of administering a normal intramuscular injection. The pain and satisfaction related to the injection were evaluated using the Visual Analog Scale and Visual Patient Satisfaction Scale after the vaccination. Pulse rates of the women were taken again by the researcher one minute after the injection.
Read the detailed description
As the rate of vaccination increases, preventable diseases and their negative effects decrease; Nevertheless, the significance of vaccine-related side effects is increasing. The most prevalent complications in vaccine applications are local reactions such as pain, swelling, and erythema at the injection site. The most frequent pain in these reactions develops after diphtheria-tetanus vaccine in which aluminum is used as an adjuvant. Diphtheria-tetanus vaccine is generally administered to the deltoid region by intramuscular injection (IM), and most pregnant women complain about the pain that they experience during and after administration of diphtheria-tetanus vaccine. Nurses have a great responsibility in reducing and eliminating the pain felt by patients during operations. The success of pain management is related to nurses' knowledge and skills. If the pain that an individual will feel due to the piercing of the skin with a needle during intramuscular injection application is decreased or reduced to minimum, the anxiety and fear that the person will experience may abate. Therefore, to reduce pain and anxiety in individuals during injection; nurses use many non-pharmacological methods. ShotBlocker (Bionix, Toledo, OH) is one of the methods that can be used to reduce pain caused by IM injections. This small, flat, U-shaped plastic device used by holding it on the skin surface during injection did not have any side effects. ShotBlocker has a surface of 2 mm thick with rounded nubs to stimulate the skin. The surface of the plastic device is placed on the skin just before the injection; there is a hole in the center where the injection is administered. The rounded nubs on the surface of the plastic device do not damage the skin, these rounded nubs that create a slight pressure provide a warning for the Gate Control Theory. ShotBlocker's mechanism of action is thought to reduce pain by stimulating nerve endings faster with pressure of rounded nubs on the device. This stimulation decreases pain by blocking pain signals temporarily during injections and by inhibiting the central nervous system.
- Conditions
- Pain, Intramuscular Injection
- Being tested
- ShotBlocker
- Keywords
- diphtheria-tetanus vaccine, intramuscular injection, pain, pain management, patient satisfaction, pregnant woman
- Medical subject headings
- Pain, Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlockerOther
ShotBlocker (Bionix, Toledo, OH) is one of the methods that can be used to reduce pain caused by IM injections. This small, flat, U-shaped plastic device used by holding it on the skin surface during injection did not have any side effects [5]. ShotBlocker has a surface of 2 mm thick with rounded nubs to stimulate the skin (Figure 1). The surface of the plastic device is placed on the skin just before the injection; there is a hole in the center where the injection is administered [6]. The rounded nubs on the surface of the plastic device do not damage the skin, these rounded nubs that create a slight pressure provide a warning for the Gate Control Theory [7]
| Study group | Role | What they receive |
|---|---|---|
| Shotblocker group | Experimental | In the ShotBlocker group, ShotBlocker was placed on the previously determined injection site before vaccination, and the vaccination was performed by holding it on the surface of the skin and pressing lightly with the fingertips. All vaccinations were carried out by an experienced nurse. ShotBlocker was removed after removing the needle. Receives: Other: ShotBlocker |
| Control group | No intervention | In the control group, the steps of administering a normal intramuscular injection were used. Except for this, no additional method was used. All vaccinations were carried out by an experienced nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
The VAS is used to assess the severity of acute pain. It is mostly a horizontal or vertical line 100 mm long, starting with "no pain" and ending with "unbearable pain". It is used to convert some values that cannot be measured numerically to a numerically usable form [10].
Measured: 6 month
Secondary outcomes (1)
Visual patient satisfaction scale
The visual patient satisfaction scale combines the characteristics of the well-known VAS. At one end of the scale is the phrase "I am not satisfied at all", and at the other end is the phrase "I am very satisfied".
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Nov 2018
- Primary completion1 Nov 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bornova No. 25 Mevlana Family Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Ince, Ege University
- Investigators
- Leyla KHORSHID, Professor, Principal investigator, khorshidleyla@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495542
- Sponsor's protocol ID
- 3023010044
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drago LA, Singh SB, Douglass-Bright A, Yiadom MY, Baumann BM. Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. Am J Emerg Med. 2009 Jun;27(5):536-43. doi: 10.1016/j.ajem.2008.04.011.
PubMed 19497458Romano CL, Cecca E. A new method to reduce pin-prick pain of intra-muscular and subcutaneous injections. Minerva Anestesiol. 2005 Oct;71(10):609-15. English, Italian.
PubMed 16163151Cobb JE, Cohen LL. A randomized controlled trial of the ShotBlocker for children's immunization distress. Clin J Pain. 2009 Nov-Dec;25(9):790-6. doi: 10.1097/AJP.0b013e3181af1324.
PubMed 19851160
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does "ShotBlocker" Affect Pain and Satisfaction During Diphtheria-Tetanus Vaccination in Pregnant Women? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05495542
- Acronym / sponsor ID
- 3023010044
- Conditions
- Pain, Intramuscular Injection
- Keywords
- diphtheria-tetanus vaccine, intramuscular injection, pain, pain management, patient satisfaction, pregnant woman
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Bornova No. 25 Mevlana Family Health CenterUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shotblocker is an effective approach to reduce injection pain. Generally, injection pain has been studied in children, but reducing injection pain in adults is an important issue. This study investigates the effect of ShotBlocker on pain and satisfaction levels associated with diphtheria-tetanus vaccination in pregnant women.
The sample of this prospective, single-blind randomized controlled experimental study consists of 146 pregnant women registered to the Family Health Center between October 2018 and June 2019. Women were assigned to ShotBlocker and control groups with 73 women in each group. The women's pulse rate was taken one minute before the injection by the researcher. In the ShotBlocker group was used ShotBlocker. The control group used the steps of administering a normal intramuscular injection. The pain and satisfaction related to the injection were evaluated using the Visual Analog Scale and Visual Patient Satisfaction Scale after the vaccination. Pulse rates of the women were taken again by the researcher one minute after the injection.
Detailed description
As the rate of vaccination increases, preventable diseases and their negative effects decrease; Nevertheless, the significance of vaccine-related side effects is increasing. The most prevalent complications in vaccine applications are local reactions such as pain, swelling, and erythema at the injection site. The most frequent pain in these reactions develops after diphtheria-tetanus vaccine in which aluminum is used as an adjuvant. Diphtheria-tetanus vaccine is generally administered to the deltoid region by intramuscular injection (IM), and most pregnant women complain about the pain that they experience during and after administration of diphtheria-tetanus vaccine. Nurses have a great responsibility in reducing and eliminating the pain felt by patients during operations. The success of pain management is related to nurses' knowledge and skills. If the pain that an individual will feel due to the piercing of the skin with a needle during intramuscular injection application is decreased or reduced to minimum, the anxiety and fear that the person will experience may abate. Therefore, to reduce pain and anxiety in individuals during injection; nurses use many non-pharmacological methods. ShotBlocker (Bionix, Toledo, OH) is one of the methods that can be used to reduce pain caused by IM injections. This small, flat, U-shaped plastic device used by holding it on the skin surface during injection did not have any side effects. ShotBlocker has a surface of 2 mm thick with rounded nubs to stimulate the skin. The surface of the plastic device is placed on the skin just before the injection; there is a hole in the center where the injection is administered. The rounded nubs on the surface of the plastic device do not damage the skin, these rounded nubs that create a slight pressure provide a warning for the Gate Control Theory. ShotBlocker's mechanism of action is thought to reduce pain by stimulating nerve endings faster with pressure of rounded nubs on the device. This stimulation decreases pain by blocking pain signals temporarily during injections and by inhibiting the central nervous system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shotblocker group | Experimental | Other: ShotBlockerIn the ShotBlocker group, ShotBlocker was placed on the previously determined injection site before vaccination, and the vaccination was performed by holding it on the surface of the skin and pressing lightly with the fingertips. All vaccinations were carried out by an experienced nurse. ShotBlocker was removed after removing the needle. |
| Control group | No intervention | –In the control group, the steps of administering a normal intramuscular injection were used. Except for this, no additional method was used. All vaccinations were carried out by an experienced nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to speak and understand Turkish
- Those who volunteered to participate in the study and received written consent
- 18 years old and over
- Those with tetanus+diphtheria vaccination prescription/demand
- No vision-hearing-speech problems
Key exclusion criteria (3 listed)
- Pregnant women who cannot speak Turkish
- Younger than 18
- Pregnant women who do not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShotBlockerShotBlocker (Bionix, Toledo, OH) is one of the methods that can be used to reduce pain caused by IM injections. This small, flat, U-shaped plastic device used by holding it on the skin surface during injection did not have any side effects [5]. ShotBlocker has a surface of 2 mm thick with rounded nubs to stimulate the skin (Figure 1). The surface of the plastic device is placed on the skin just before the injection; there is a hole in the center where the injection is administered [6]. The rounded nubs on the surface of the plastic device do not damage the skin, these rounded nubs that create a slight pressure provide a warning for the Gate Control Theory [7] | Other | Shotblocker group |
Primary outcome
Visual analog scale
Time frame: 6 month
The VAS is used to assess the severity of acute pain. It is mostly a horizontal or vertical line 100 mm long, starting with "no pain" and ending with "unbearable pain". It is used to convert some values that cannot be measured numerically to a numerically usable form [10].
1 secondary outcome
Visual patient satisfaction scale
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Results publication: PubMed 19497458Drago LA, Singh SB, Douglass-Bright A, Yiadom MY, Baumann BM. Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. Am J Emerg Med. 2009 Jun;27(5):536-43. doi: 10.1016/j.ajem.2008.04.011.
- Results publication: PubMed 16163151Romano CL, Cecca E. A new method to reduce pin-prick pain of intra-muscular and subcutaneous injections. Minerva Anestesiol. 2005 Oct;71(10):609-15. English, Italian.
- Results publication: PubMed 19851160Cobb JE, Cohen LL. A randomized controlled trial of the ShotBlocker for children's immunization distress. Clin J Pain. 2009 Nov-Dec;25(9):790-6. doi: 10.1097/AJP.0b013e3181af1324.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leyla KHORSHID, Professor principal investigator
khorshidleyla@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShotBlocker in people with Pain and Intramuscular Injection, run by Bornova No. 25 Mevlana Family Health Center at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495542, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.