Vibration and Shotblocker Use in Pregnant Women While Giving Tetanus + Diphtheria Vaccine

NCT05701904 | Completed

• 1 other identifier: HKU-SBF-SA-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Tetanus-diphtheria vaccine administered to pregnant women may cause pain during and after administration. Due to the pain that may occur, the compliance of pregnant women towards the vaccine may be impaired. Therefore, there is a need for methods that are safe for pregnant women to reduce pain. One of the applications used to reduce pain during intramuscular injection is local mechanical vibration application. With the application of vibration, the tactile receptors are stimulated and the pain is localized in a more limited area. One of the methods used to reduce the pain felt during intramuscular injection is the application of shotblocker applied to the injection site. The protrusions on the Shotbloker temporarily suppress the pain thanks to the pressure it exerts on the skin. Thus, the gates to the central nervous system are closed and pain is reduced. Mechanical vibration and shotblocker procedures applied before injection are non-invasive. Being simple and safe, it is one of the appropriate methods that can be preferred by pregnant women to reduce injection pain. Therefore, in our study, it is aimed to examine the effect of local mechanical vibration and shotblocker application on pain and patient satisfaction before tetenosis-diphtheria vaccine in pregnant women.

Conditions

Pain

Keywords

Nursing care; Management, Pain; Patient Satisfaction; Intramuscular Injections

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  The VAS is a 100 mm straight horizontal line with numbers from 0 to 10 representing the patient's initial pain-free and finally the most severe pain they can feel. '0' means no pain, '10' means severe pain. Participants are asked to mark any number between "0" and "10".

  4 months

Secondary Outcomes (1)

• Visual Patient Satisfaction Scale

  4 months

Study Arms (3)

Local mechanical vibration applied group

EXPERIMENTAL

Before the injection, local mechanical vibration will be applied for 3 minutes with a vibration device to the deltoid muscle where the injection will be made, and then the vaccine will be given. The vibration device to be used is suitable for contact with the skin and provides 6000 rotations per minute with vibration. Pregnant women who were asked to receive tetanus+diphtheria vaccine by their physician and agreed to participate in the study will be informed about the research by the researcher, and their written and verbal consents will be obtained. Then the vaccine will be administered. Td vaccine will be administered to all pregnant women in the study as IM to the deltoid muscle in the arm they do not use dominantly. Five minutes after the vaccination, the individual descriptor form will be applied to all pregnant women, and the pregnant women will score their satisfaction levels with regard to pain and the method used.

Other: Local mechanical vibration

Shotblocker group

EXPERIMENTAL

It is a U-shaped device with skin contact points on the shotblocker and an opening in the middle for injecting. The Shotblocker will be placed on the skin surface just before inserting the needle and gently pressed with the fingertips, and the vaccine will be administered immediately afterwards. After removing the needle, the shotblocker will be removed. Pregnant women who were asked to receive tetanus+diphtheria vaccine by their physician and agreed to participate in the study will be informed about the research by the researcher, and their written and verbal consents will be obtained. Then the vaccine will be administered. Td vaccine will be administered to all pregnant women in the study as IM to the deltoid muscle in the arm they do not use dominantly. Five minutes after the vaccination, the individual descriptor form will be applied to all pregnant women, and the pregnant women will score their satisfaction levels with regard to pain and the method used.

Other: Shotblocker group

Control group

NO INTERVENTION

The vaccine will be administered by following the standard intramuscular injection procedure. Five minutes after vaccination, an individual descriptive form will be applied to all pregnant women, and pregnant women will score their pain and satisfaction levels with scales. Pregnant women who were asked to receive tetanus+diphtheria vaccine by their physician and agreed to participate in the study will be informed about the research by the researcher, and their written and verbal consents will be obtained. Then the vaccine will be administered. Td vaccine will be administered to all pregnant women in the study as IM to the deltoid muscle in the arm they do not use dominantly. Five minutes after the vaccination, the individual descriptor form will be applied to all pregnant women, and the pregnant women will score their satisfaction levels with regard to pain and the method used.

Interventions

Local mechanical vibration OTHER

Before the injection, local mechanical vibration will be applied for 3 minutes with a vibration device to the deltoid muscle where the injection will be made, and then the vaccine will be given. The vibration device to be used is suitable for contact with the skin and provides 6000 rotations per minute with vibration.

Local mechanical vibration applied group

Shotblocker group OTHER

It is a U-shaped device with skin contact points on the shotblocker and an opening in the middle for injection (Tugrul, Celik, and Khorshid 2017). The Shotblocker will be placed on the skin surface just before inserting the needle and gently pressed with the fingertips, and the vaccine will be administered immediately afterwards. After removing the needle, the shotblocker will be removed.

Shotblocker group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women with tetanus + diphtheria vaccination order
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those who volunteered to participate in the study and received written consent
• Pregnant women who were prescribed tetanus + diphtheria vaccine
• No acute cause of pain other than injection pain
• Able to communicate verbally
• Pregnant women over the age of 18

You may not qualify if:

• Not willing to participate in the study
• Pregnant women who are not prescribed tetanus + diphtheria vaccine
• An acute cause of pain other than injection pain
• Unable to communicate verbally
• Pregnant women under the age of 18
• Those over the age of 18 who are not pregnant

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

Related Publications (2)

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 RESULT

• Dincer B, Yildirim D. The effect of vibration stimulation on intramuscular injection pain and patient satisfaction: Single-blind, randomised controlled study. J Clin Nurs. 2021 Jun;30(11-12):1615-1622. doi: 10.1111/jocn.15715. Epub 2021 Mar 1.

  PMID: 33590594 RESULT

MeSH Terms

Conditions

Pain; Agnosia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, Doktora Öğrencisi

Model Details: a control group and 2 intervention groups

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 27, 2023
• Study Start: February 20, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)