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Evaluation of Deltoid Exercises on Injection Site Pain After (BNT162b2) COVID - 19 Vaccination

NCT05157230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2022-01-11

No results posted yet for this study

Summary

Pfizer - BioNTech (BNT162b2) COVID - 19 vaccine is the first vaccine to be approved for emergency use by FDA. The most commonly reported side effect of the BNT162b2 vaccination is mild-to-moderate pain at injection site, i.e. deltoid muscle. Injection site pain may be observed during and after vaccine injection, and severity of pain may vary according to the type of vaccine, patients age, sex, level of anxiety, needle size, injection site and technique and patient positioning. Vaccination pain is one of the reasons of vaccine hesitancy and World Health Organization (WHO) recommended various measures to mitigate pain at the time of vaccination.

Exercise is one of the suggested methods to relieve the pain and anxiety in various conditions including vaccination site pain. However, we found no studies addressing injection site pain after the vaccination and pain associated with BNT162b2 vaccine. Aim of our study is to evaluate effectiveness of deltoid muscle exercises to relieve injection site pain observed after BNT162b2 vaccination.

Conditions

  • Vaccines, Adverse Effects
  • Injection Site Reaction

Interventions

BEHAVIORAL

exercise

volunteers in the exercise arm instructed to do three basic deltoid muscle exercises 3 times daily at least 20 repetitions for each exercise for five days. exercises were side lateral shoulder raises, front shoulder raises with hyperextension and mid range arm circles.

Sponsors & Collaborators

  • Bursa Yuksek Ihtisas Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Zulfi Engindeniz, MD · Bursa Yuksek Ihtisas Reseach and Training Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2021-12-15
Completion
2021-12-25

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT05157230 on ClinicalTrials.gov