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

Not Applicable

Recruiting

• Conditions: Pregnant Women

• Registration Number: NCT06976632
• Lead Sponsor: Celal Bayar University

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study Start: 2025-05-09
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-05-09
• Study Completion: 2026-05-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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."
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.

Secondary Outcome Measures

Name	Time	Method
Monitoring the systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) of the pregnant women	before the injection, immediately after the injection, and 15 minutes after the injection	In the study, systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg), which is one of the physiological effects of pain, will be recorded three times.
Monitoring the heart rate (per minute) of the pregnant women	before the injection, immediately after the injection, and 15 minutes after the injection	In the study, heart rate (per minute), which is one of the physiological effects of pain, will be recorded three times.
Monitoring the respiratory rate (per minute) of the pregnant women	before the injection, immediately after the injection, and 15 minutes after the injection	In the study, respiratory rate (per minute), which is one of the physiological effects of pain, will be recorded three times.
Monitoring the peripheral oxygen saturation (%) of the pregnant women	before the injection, immediately after the injection, and 15 minutes after the injection	In the study, peripheral oxygen saturation (%), which is one of the physiological effects of pain, will be recorded three times.

Trial Locations

Locations (1)

Manisa Celal Bayar University; 🇹🇷 Manisa, Uncubozköy/Yunusemre, Turkey