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

Study Overview
=================
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Vaccines, Adverse Effects, Injection Site Reaction

Intervention / Treatment
-----------------
* Behavioral: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>volunteers in this group do shoulder/arm exercises after vaccine injection and fill in the pain diary | Behavioral: exercise<br>* 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.<br>|
| No Intervention: no-exercise<br>volunteers in this arm only completed the pain diary without any intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of analgesics | self reported use of any analgesics | within 5 days after vaccination | 
| hospital admission | self reported admission to hospital for reasons related to vaccination | within 5 days after vaccination | 
| mean daily pain score | difference in mean daily pain score in numeric rating scale | within 5 days after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BNT162B2, exercise, Injection Site Reaction, Pain Management