Clinical trial NCT05701904: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Nursing care
Management, Pain
Patient Satisfaction
Intramuscular Injections
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a control group and 2 intervention groups
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 4 months
Secondary outcomes:
measure: Visual Patient Satisfaction Scale
timeFrame: 4 months
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References:
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.
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.