Effect of Helfer Skin Tap and Cold Application on Pain and Hemodynamics During Vaccination

This randomized controlled study aims to evaluate the effects of the Helfer Skin Tap Technique and local cold application on pain intensity and hemodynamic parameters during intramuscular tetanus vaccination in pregnant women. The sample size will be calculated prior to data collection using the G*Power 3.1.9.2 software. Pregnant women included in the sample will be randomly assigned to three groups using the Research Randomizer program.

According to the randomization:

Group 1 (intervention) will receive the tetanus vaccine using the Helfer Skin Tap Technique, Group 2 (intervention) will receive the vaccine with local cold application, Group 3 (control) will receive the standard IM injection without additional intervention.

Data will be collected from pregnant women who are followed by Soma No. 5 Family Health Center and who apply to the institution for tetanus vaccination during pregnancy. The data collection tools include a Personal Information Form, Numeric Pain Rating Scale (NPRS), the Helfer Skin Tap IM Injection Procedure Guideline, Cold Compress Gel IM Injection Guideline, and Standard IM Injection Guideline.

Injections will be administered to participants in all groups according to the respective guidelines. Vital signs (such as heart rate, blood pressure, peripheral oxygen saturation (%), and respiratory rate) will be measured before injection, immediately after injection, and 15 minutes post-injection. Pain levels will be assessed immediately and at the 15th minute following the injection. Additionally, to evaluate the longer-term effects of pain, participants will be contacted via a follow-up link and asked to report their pain levels at the 24th and 48th hours after vaccination.

Inclusion criteria

Pregnant women who meet the following criteria will be included in the study:

• Over the age of 18,
• Scheduled to receive a tetanus vaccine,
• Able to speak and communicate in Turkish,
• Willing to participate in the study,
• Not experiencing any pain for any reason prior to the injection.

Exclusion criteria

Pregnant women who meet any of the following criteria will be excluded from the study:

• Under the age of 18,
• Received a tetanus vaccine for reasons other than pregnancy,
• Received a vaccine other than tetanus,
• Experiencing pain for any reason prior to the vaccine,
• Have circulatory disorders or peripheral vascular disease,
• Have bleeding or clotting disorders,
• Have a local infection,
• Used painkillers at least 6 hours prior to the procedure,
• Underwent a painful procedure within the last hour,
• Have cold sensitivity,
• Have cognitive or psychological issues.