Actively Recruiting
Comparison of the Effects of the Helfer Skin Tap Technique and Local Cold Application on Pain and Hemodynamic Parameters During Vaccination in Pregnant Women
Led by Celal Bayar University · Updated on 2026-03-20
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effects of the Helfer Skin Tap Technique and local cold application on pain and hemodynamic responses during intramuscular tetanus vaccination in pregnant women. The study will compare these two methods with the standard injection procedure to see how they influence pain intensity and vital signs such as heart rate and blood pressure. Pregnant women receiving tetanus vaccination will be randomly assigned to three groups for this evaluation. Participants will be divided into three groups: one will receive the vaccine using the Helfer Skin Tap Technique, which involves gently tapping the skin during injection; another will receive the injection after applying a cold gel compress to the injection site for one minute; and the control group will receive the standard intramuscular injection without additional intervention. The process follows specific guidelines for each group to ensure consistency. During the study, vital signs including heart rate, blood pressure, respiratory rate, and oxygen saturation will be measured before, immediately after, and 15 minutes post-injection. Pain levels will be assessed right after injection, 15 minutes later, and again at 24 and 48 hours after vaccination through follow-up contact. This detailed monitoring aims to capture both immediate and longer-term effects of the interventions on pain and physiological responses.
CONDITIONS
Brief Title
Effect of Helfer Skin Tap and Cold Application on Pain and Hemodynamics During Vaccination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women over 18 years old
- Scheduled to receive a tetanus vaccine
- Able to speak and communicate in Turkish
- Willing to participate in the study
- Not experiencing any pain before the injection
You will not qualify if you...
- Under 18 years old
- Received a tetanus vaccine for reasons other than pregnancy
- Received a vaccine other than tetanus
- Experiencing pain prior to vaccination
- Have circulatory disorders or peripheral vascular disease
- Have bleeding or clotting disorders
- Have a local infection
- Used painkillers within 6 hours before the procedure
- Underwent a painful procedure within the last hour
- Have cold sensitivity
- Have cognitive or psychological issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a tetanus vaccine by one of three methods: the Helfer Skin Tap Technique, local cold application, or the standard intramuscular injection. Vital signs are measured before injection, immediately after, and 15 minutes post-injection. Pain is assessed immediately and 15 minutes after the injection.
1 vaccination visit (in-person)
Duration - 2 days
Participants report their pain levels at 24 and 48 hours after vaccination through a follow-up link to evaluate longer-term pain effects.
Pain assessments at 24 and 48 hours post-vaccination (remote)
Trial Site Locations
Total: 1 location
1
Manisa Celal Bayar University
Manisa, Uncubozköy/Yunusemre, Turkey (Türkiye), 45030
Actively Recruiting
Research Team
S
Sevgi PAKİŞ ÇETİN, Asst. Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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