Evaluation of Deltoid Exercises on Injection Site Pain After (BNT162b2) COVID - 19 Vaccination
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Bursa, 칠면조, 16000
- BursaYuksek Ihtisas Research and Training Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: exercise
volunteers in this group do shoulder/arm exercises after vaccine injection and fill in the pain diary
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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.
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간섭 없음: no-exercise
volunteers in this arm only completed the pain diary without any intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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time to no pain at injection site or arm
기간: within 5 days after vaccination
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time frame between the time of vaccination and self reported time of being pain free
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within 5 days after vaccination
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
use of analgesics
기간: within 5 days after vaccination
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self reported use of any analgesics
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within 5 days after vaccination
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hospital admission
기간: within 5 days after vaccination
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self reported admission to hospital for reasons related to vaccination
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within 5 days after vaccination
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mean daily pain score
기간: within 5 days after vaccination
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difference in mean daily pain score in numeric rating scale
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within 5 days after vaccination
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공동 작업자 및 조사자
수사관
- 수석 연구원: Zulfi Engindeniz, MD, Bursa Yuksek Ihtisas Reseach and Training Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2021-KAEK-25 2021/08-21
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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