Effects of Helfer Skin Tap and Cold Application on Pain During Vaccination
Comparison of the Effects of the Helfer Skin Tap Technique and Local Cold Application on Pain and Hemodynamic Parameters During Vaccination in Pregnant Women
This study tests whether a special tapping technique or cold application can help reduce pain during tetanus vaccinations for pregnant women compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | Celal Bayar University Academic / other |
| Locations | 1 site (Manisa, Uncubozköy/Yunusemre) |
| Trial ID | NCT06976632 on ClinicalTrials.gov |
What this trial studies
This study investigates how the Helfer Skin Tap Technique and local cold application affect pain levels and vital signs during the tetanus vaccination in pregnant women. It is a randomized controlled trial where participants will be assigned to one of three groups: one receiving the Helfer Skin Tap Technique, another receiving local cold application, and a control group receiving standard injection without additional interventions. Pain intensity and hemodynamic parameters will be measured before, immediately after, and 15 minutes post-injection to assess the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over the age of 18 who are scheduled to receive a tetanus vaccine and can communicate in Turkish.
Not a fit: Patients who may not benefit include those under 18, those with pain prior to the injection, or those with specific medical conditions such as circulatory disorders or infections.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for pregnant women receiving vaccinations.
How similar studies have performed: While similar approaches have been explored, this specific combination of techniques in pregnant women during vaccination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Manisa, Uncubozköy/Yunusemre
- Manisa Celal Bayar University — Manisa, Uncubozköy/Yunusemre, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Sevgi Pakiş Çetin, Asst. Prof. — Celal Bayar University
- Study coordinator: Sevgi PAKİŞ ÇETİN, Asst. Prof.
- Email: sevgi.pakiscetin@cbu.edu.tr
- Phone: +90 (236) 233 71 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.