The Effect of ShotBlocker on Injection Pain

NCT05495542 | Completed DMC

• 1 other identifier: 3023010044
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Intramuscular Injection

Keywords

diphtheria-tetanus vaccine; intramuscular injection; pain; pain management; patient satisfaction; pregnant woman

Outcome Measures

Primary Outcomes (1)

• 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 \[10\].

  6 month

Secondary Outcomes (1)

• Visual patient satisfaction scale

  6 month

Study Arms (2)

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.

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.

Interventions

ShotBlocker OTHER

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 \[7\]

Shotblocker group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women were included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to speak and understand Turkish
• Those who volunteered to participate in the study and received written consent
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bornova No. 25 Mevlana Family Health Center: lead

Study Sites (1)

Merve

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 19497458 RESULT

• 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.

  PMID: 16163151 RESULT

• 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.

  PMID: 19851160 RESULT

MeSH Terms

Conditions

Pain; Agnosia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Leyla KHORSHID, Professor

  khorshidleyla@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants in the study and the researcher who evaluated the pain were blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 10, 2022
• Study Start: November 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: May 30, 2019
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)