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

Primary Purpose

Vaccines, Adverse Effects, Injection Site Reaction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vaccines, Adverse Effects focused on measuring BNT162B2, exercise, Injection Site Reaction, Pain Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • BursaYuksek Ihtisas Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

exercise

no-exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

time to no pain at injection site or arm
time frame between the time of vaccination and self reported time of being pain free

Secondary Outcome Measures

use of analgesics
self reported use of any analgesics
hospital admission
self reported admission to hospital for reasons related to vaccination
mean daily pain score
difference in mean daily pain score in numeric rating scale

Full Information

First Posted
December 11, 2021
Last Updated
January 8, 2022
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05157230
Brief Title
Evaluation of Deltoid Exercises on Injection Site Pain After (BNT162b2) COVID - 19 Vaccination
Official Title
Evaluation of Deltoid Muscle Exercises on Injection Site and Arm Pain After Pfizer - BioNTech (BNT162b2) COVID - 19 Vaccination, A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccines, Adverse Effects, Injection Site Reaction
Keywords
BNT162B2, exercise, Injection Site Reaction, Pain Management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise
Arm Type
Experimental
Arm Description
volunteers in this group do shoulder/arm exercises after vaccine injection and fill in the pain diary
Arm Title
no-exercise
Arm Type
No Intervention
Arm Description
volunteers in this arm only completed the pain diary without any intervention
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
time to no pain at injection site or arm
Description
time frame between the time of vaccination and self reported time of being pain free
Time Frame
within 5 days after vaccination
Secondary Outcome Measure Information:
Title
use of analgesics
Description
self reported use of any analgesics
Time Frame
within 5 days after vaccination
Title
hospital admission
Description
self reported admission to hospital for reasons related to vaccination
Time Frame
within 5 days after vaccination
Title
mean daily pain score
Description
difference in mean daily pain score in numeric rating scale
Time Frame
within 5 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zulfi Engindeniz, MD
Organizational Affiliation
Bursa Yuksek Ihtisas Reseach and Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
BursaYuksek Ihtisas Research and Training Hospital
City
Bursa
ZIP/Postal Code
16000
Country
Turkey

12. IPD Sharing Statement

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

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