Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 1:45 PM
Study NCT ID:
NCT06976632
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Helfer Skin Tap and Cold Application on Pain and Hemodynamics During Vaccination
Sponsor:
Celal Bayar University
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: