Clinical trial NCT05495542: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Intramuscular Injection
Keywords: diphtheria-tetanus vaccine
intramuscular injection
pain
pain management
patient satisfaction
pregnant woman
Lead sponsor: Bornova No. 25 Mevlana Family Health Center
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Visual analog scale
timeFrame: 6 month
Secondary outcomes:
measure: Visual patient satisfaction scale
timeFrame: 6 month
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Merve
state: Bornova
Study officials:
affiliation: khorshidleyla@gmail.com
name: Leyla KHORSHID, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.