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

8. januar 2022 opdateret af: Zulfı engındenız, Bursa Yüksek İhtisas Education and Research Hospital

Evaluation of Deltoid Muscle Exercises on Injection Site and Arm Pain After Pfizer - BioNTech (BNT162b2) COVID - 19 Vaccination, A Randomized Controlled Study

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study was started at the designated COVID - 19 vaccination department of Bursa Yuksek Ihtisas research and training hospital Approvals was obtained from Republic of Turkey Ministry of Health and institutional review board and ethics committee and the study was conducted in concordance with Declaration of Helsinki.

Volunteers were selected among the healthy persons who admitted to our vaccination department to have BNT162b2 vaccine. Selection criteria were age being over 18, having no physical disability to perform the physical exercises given and willingness to participate in the study and sign an informed consent. People under the age of 18, patients with conditions that prevent them doing the exercises given and who did not want to participate in the study were excluded from the study.

Volunteers who accept to participate in the study, were randomized in to exercise vs. no-exercise groups according to a previously formed online randomization list. All volunteer's demographic data and vaccination status (first or second dose) were recorded. Both groups were asked to keep a five - day pain diary using numeric rating scale (NRS) and to also record any use of analgesics, any hospital admissions, any side effects other than injection site and arm pain and the time of cessation of pain.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

401

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kalkun
      • Bursa, Kalkun, 16000
        • BursaYuksek Ihtisas Research and Training Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: exercise
volunteers in this group do shoulder/arm exercises after vaccine injection and fill in the pain diary
Adfærdsmæssigt: 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.
Ingen indgriben: no-exercise
volunteers in this arm only completed the pain diary without any intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
time to no pain at injection site or arm
Tidsramme: within 5 days after vaccination
time frame between the time of vaccination and self reported time of being pain free
within 5 days after vaccination

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
use of analgesics
Tidsramme: within 5 days after vaccination
self reported use of any analgesics
within 5 days after vaccination
hospital admission
Tidsramme: within 5 days after vaccination
self reported admission to hospital for reasons related to vaccination
within 5 days after vaccination
mean daily pain score
Tidsramme: within 5 days after vaccination
difference in mean daily pain score in numeric rating scale
within 5 days after vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Efterforskere

  • Ledende efterforsker: Zulfi Engindeniz, MD, Bursa Yuksek Ihtisas Reseach and Training Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2021

Primær færdiggørelse (Faktiske)

15. december 2021

Studieafslutning (Faktiske)

25. december 2021

Datoer for studieregistrering

Først indsendt

11. december 2021

Først indsendt, der opfyldte QC-kriterier

11. december 2021

Først opslået (Faktiske)

14. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021-KAEK-25 2021/08-21

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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