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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Pain

Intervention / Treatment
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* Other: Local mechanical vibration
* Other: Shotblocker group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a control group and 2 intervention groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local mechanical vibration applied group<br>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<br>* 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.<br>|
| Experimental: Shotblocker group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Patient Satisfaction Scale | 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. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing care, Management, Pain, Patient Satisfaction, Intramuscular Injections