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Recruiting Not applicable

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

NCT06976632 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-05-09
Last updated
2026-03-20

Condition(s) studied

Pregnant Women

Investigational drug(s) / intervention(s)

Helfer Skin Tap TecniqueLocal Cold Application

Helfer Skin Tap Tecnique: In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the "Individual Identification Form" will be completed. In the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Following this, tetanus vaccination will be administered to the pregnant women in the intervention group using the Helfer Skin Tap technique in accordance with the "Helfer Skin Tap IM Injection Procedure Guideline". In the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by the nurse, and the vital signs of the pregnant women will be measured again. To evaluate the long-term effects of pain, participants will be contacted via a link, and pain assessments will be conducted at the 24th and 48th hours following the vaccination.

Local Cold Application: In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the "Individual Identification Form" will be completed. In the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Subsequently, tetanus vaccination will be administered to the pregnant women in the intervention group using a cold compress gel, based on the "Cold Compress Gel IM Injection Procedure Guideline" developed in line with the relevant literature. In the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by nurse, and the vital signs of the pregnant women will be measured again. Pain assessment will be repeated at the 24th and 48th hours following the vaccination.

Study summary

The purpose of this study is to investigate the effect of local cold application using the Helfer Skin Tap Technique on pain levels during the intramuscular injection of the tetanus vaccine in pregnant women. The study will also record vital signs, which are among the physiological effects of pain.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
42 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Individual Identification Form — It was implemented on the first day of the study.
    The "Individual Identification Form," which includes the sociodemographic characteristics of the pregnant women, was developed by the researchers based on the relevant literature. The form consists of 9 questions.
  • Use of a numerical pain scale in the assessment of injection-related pain — immediately after the injection, 15 minutes later, and at the 24th and 48th hours
    Pain assessment related to the injection in pregnant women will be conducted using the Numerical Pain Scale immediately after the injection, 15 minutes later, and at the 24th and 48th hours. It is based on the principle that patients circle the number representing the amount of pain they experience on a 10 cm horizontal scale, with "No Pain" written at the far left and "Severe Pain" at the far right. When evaluating pain intensity, a score of 0 indicates "No pain," 1-3 points indicate "Mild pain," 4-6 points indicate "Moderate pain," and 7-10 points indicate "Severe pain."

Trial sites (1)

FacilityCityRegionStatus
Manisa Celal Bayar University Manisa Uncubozköy/Yunusemre Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06976632 on ClinicalTrials.gov ↗ ← All trials in Turkey