RecruitingNot Applicable

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

Turkey (Türkiye)90 participantsStarted 2025-05-09

Plain-language 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.

Who can participate

Age range

18 Years – 42 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Individual Identification Form

Timeframe: It was implemented on the first day of the study.

Use of a numerical pain scale in the assessment of injection-related pain

Timeframe: immediately after the injection, 15 minutes later, and at the 24th and 48th hours

Trial details

NCT IDNCT06976632

SponsorManisa Celal Bayar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-09

Contact for this trial

Sevgi PAKİŞ ÇETİN, Asst. Prof.

+90 (236) 233 71 69 sevgi.pakiscetin@cbu.edu.tr

View on ClinicalTrials.gov More Pregnant Women trials