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

NCT05157230 | Completed

• 1 other identifier: 2021-KAEK-25 2021/08-21
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BNT162B2; exercise; Injection Site Reaction; Pain Management

Outcome Measures

Primary Outcomes (1)

• time to no pain at injection site or arm

  time frame between the time of vaccination and self reported time of being pain free

  within 5 days after vaccination

Secondary Outcomes (3)

• use of analgesics

  within 5 days after vaccination

• hospital admission

  within 5 days after vaccination

• mean daily pain score

  within 5 days after vaccination

Study Arms (2)

exercise

EXPERIMENTAL

volunteers in this group do shoulder/arm exercises after vaccine injection and fill in the pain diary

Behavioral: exercise

no-exercise

NO INTERVENTION

volunteers in this arm only completed the pain diary without any intervention

Interventions

exercise BEHAVIORAL

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.

exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• vaccination with Bnt162b2
• having no physical disability to perform the physical exercises given
• willingness to participate in the study and sign the informed consent form

You may not qualify if:

• vaccination with vaccines other than Bnt162b2
• having physical disability to perform the physical exercises given
• not willing to participate in the study and sign the informed consent form

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

BursaYuksek Ihtisas Research and Training Hospital

Bursa, 16000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Injection Site Reaction; Motor Activity; Agnosia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zulfi Engindeniz, MD

  Bursa Yuksek Ihtisas Reseach and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zulfi Engindeniz, MD, Principal investigator

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: December 14, 2021
• Study Start: September 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 25, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

TU (1)