search
Back to results

The Effect of ShotBlocker on Injection Pain

Primary Purpose

Pain, Intramuscular Injection

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ShotBlocker
Sponsored by
Bornova No. 25 Mevlana Family Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring diphtheria-tetanus vaccine, intramuscular injection, pain, pain management, patient satisfaction, pregnant woman

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Pregnant women who cannot speak Turkish
  • Younger than 18
  • Pregnant women who do not want to participate in the study

Sites / Locations

  • Merve

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Shotblocker group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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].

Secondary Outcome Measures

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".

Full Information

First Posted
August 5, 2022
Last Updated
August 8, 2022
Sponsor
Bornova No. 25 Mevlana Family Health Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05495542
Brief Title
The Effect of ShotBlocker on Injection Pain
Official Title
Does "ShotBlocker" Affect Pain and Satisfaction During Diphtheria-Tetanus Vaccination in Pregnant Women? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bornova No. 25 Mevlana Family Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Intramuscular Injection
Keywords
diphtheria-tetanus vaccine, intramuscular injection, pain, pain management, patient satisfaction, pregnant woman

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The participants in the study and the researcher who evaluated the pain were blinded.
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shotblocker group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ShotBlocker
Intervention Description
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]
Primary Outcome Measure Information:
Title
Visual analog scale
Description
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].
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Visual patient satisfaction scale
Description
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".
Time Frame
6 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women were included in the study.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Pregnant women who cannot speak Turkish Younger than 18 Pregnant women who do not want to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leyla KHORSHID, Professor
Organizational Affiliation
khorshidleyla@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Merve
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19497458
Citation
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.
Results Reference
result
PubMed Identifier
16163151
Citation
Romano 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 Reference
result
PubMed Identifier
19851160
Citation
Cobb 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.
Results Reference
result

Learn more about this trial

The Effect of ShotBlocker on Injection Pain

We'll reach out to this number within 24 hrs