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

Primary Purpose

Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Local mechanical vibration
Shotblocker group
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Nursing care, Management, Pain, Patient Satisfaction, Intramuscular Injections

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Local mechanical vibration applied group

Shotblocker group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.

Full Information

First Posted
January 9, 2023
Last Updated
January 18, 2023
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05701904
Brief Title
Vibration and Shotblocker Use in Pregnant Women While Giving Tetanus + Diphtheria Vaccine
Official Title
Investigation of the Effect of Local Mechanical Vibration and Shotblocker Application on Pain and Patient Satisfaction Before Tetanus + Diphtheria Vaccine in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 20, 2023 (Anticipated)
Primary Completion Date
January 20, 2023 (Anticipated)
Study Completion Date
June 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

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
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Nursing care, Management, Pain, Patient Satisfaction, Intramuscular Injections

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a control group and 2 intervention groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local mechanical vibration applied group
Arm Type
Experimental
Arm Description
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.
Arm Title
Shotblocker group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Local mechanical vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Shotblocker group
Intervention Description
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 Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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".
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Visual Patient Satisfaction Scale
Description
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.
Time Frame
4 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women with tetanus + diphtheria vaccination order
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Senem Andı
Phone
+905077257047
Email
senemperktas@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Betül Tosun
Phone
+905053652121
Email
tosunbetul@gmail.com
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22588748
Citation
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.
Results Reference
result
PubMed Identifier
33590594
Citation
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.
Results Reference
result

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

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