Clinical trial NCT06976632: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnant Women
Keywords: immunization
pain
hemodynamic parameters
pregnant women
local cold application
helfer skin tap tecnique
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The pregnant women to be assigned to the group will be determined using the Research Randomizer program. In the first phase of the study, pregnant women who accept to participate and meet the sample selection criteria will be informed about the study, and written and verbal consent will be obtained. Then, before the intramuscular tetanus vaccination, a "Personal Information Form" will be filled out by one of the researchers, the institution nurse, using a face-to-face interview technique. In the second phase, the nurse will measure the vital signs of the pregnant women. Then, the vaccine will be administered using the method used. In the third phase of the study, pain assessment will be made using the NPS immediately after the procedure and 15 minutes later, and the vital signs of the pregnant women will be measured. Pain evaluation will be conducted 24 and 48 hours after the vaccination.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Individual Identification Form
timeFrame: It was implemented on the first day of the study.
measure: 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
Secondary outcomes:
measure: Monitoring the systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) of the pregnant women
timeFrame: before the injection, immediately after the injection, and 15 minutes after the injection
measure: Monitoring the heart rate (per minute) of the pregnant women
timeFrame: before the injection, immediately after the injection, and 15 minutes after the injection
measure: Monitoring the respiratory rate (per minute) of the pregnant women
timeFrame: before the injection, immediately after the injection, and 15 minutes after the injection
measure: Monitoring the peripheral oxygen saturation (%) of the pregnant women
timeFrame: before the injection, immediately after the injection, and 15 minutes after the injection
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
state: Uncubozköy/Yunusemre
Study officials:
affiliation: Celal Bayar University
name: Sevgi Pakiş Çetin, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: