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The Effect of ShotBlocker on Injection Pain

NCT05495542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2022-08-10

No results posted yet for this study

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

Interventions

OTHER

ShotBlocker

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 \[7\]

Sponsors & Collaborators

  • Bornova No. 25 Mevlana Family Health Center

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2018-11-01
Completion
2019-05-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05495542 on ClinicalTrials.gov