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NCT Number: NCT05701904

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

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.

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Key information

Conditions

Pain Agnosia Behavior Health Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

About this study

Pregnant women who meet the inclusion criteria of the study, who request tetanus-diphtheria (0.5 ml) by their family physician, and who agree to participate in the study will be informed about the study and their written and verbal consents will be obtained. Then the vaccine will be administered. Tetanus-diphtheria vaccine will be administered to all pregnant women in the study by IM in the deltoid muscle in the arm they do not use dominantly.

Data Collection Tools Individual Introduction Form It was prepared by the researchers by scanning the literature . In the introductory form, there are questions about the age, education level, marital status, occupation, income status, smoking status, gestational week, tetonosis vaccination status, height-weight of the pregnant women.

Visual Analog Scale (VAS) VAS patients are initially painless and eventually represent the most severe pain they can feel.

It is a 100 mm straight horizontal line with numbers 0 to 10. '0' means no pain, '10' means severe pain. Participants are asked to mark any number between "0" and "10".

Visual Patient Satisfaction Scale Visual patient satisfaction scale (visual analogue patient satisfaction scale) overlaps with the features of VAS. It indicates the degree of satisfaction out of 10. On one side of the scale, "0" (Not at all satisfied) and on the other side "10" (Very satisfied).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 4 months

    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".

Secondary outcomes

  1. Visual Patient Satisfaction Scale

    Time frame: 4 months

    Visual patient satisfaction scale (visual analog patient satisfaction scale) overlaps with the features of the Visual Analog Scale. It indicates the degree of satisfaction out of 10. On one side of the scale, "0" (Not at all satisfied) and "10" (Very satisfied) are on the other side.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

Investigation of the Effect of Local Mechanical Vibration and Shotblocker Application on Pain and Patient Satisfaction Before Tetanus + Diphtheria Vaccine in Pregnant Women

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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