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

Official title

Comparison of the Effects of the Helfer Skin Tap Technique and Local Cold Application on Pain and Hemodynamic Parameters During Vaccination in Pregnant Women

Overview

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.

Interventions

• Behavioral 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
• Behavioral 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, b

Primary outcome measures

• Individual Identification Form [Time frame: It was implemented on the first day of the study.]
• Use of a numerical pain scale in the assessment of injection-related pain [Time frame: immediately after the injection, 15 minutes later, and at the 24th and 48th hours]

Secondary outcome measures (4)

• Monitoring the systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) of the pregnant women [Time frame: before the injection, immediately after the injection, and 15 minutes after the injection]
• Monitoring the heart rate (per minute) of the pregnant women [Time frame: before the injection, immediately after the injection, and 15 minutes after the injection]
• Monitoring the respiratory rate (per minute) of the pregnant women [Time frame: before the injection, immediately after the injection, and 15 minutes after the injection]
• Monitoring the peripheral oxygen saturation (%) of the pregnant women [Time frame: before the injection, immediately after the injection, and 15 minutes after the injection]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Manisa Celal Bayar University — Manisa

Identifiers

NCT: NCT06976632 · 20.478.486/2967

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗