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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-09

Study Completion Date

2026-05-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnant Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

In this study, participants were randomly assigned to groups in order to evaluate the effectiveness of nursing interventions. Randomization was carried out by creating 3 sets, each containing 30 unique numbers ranging from 1 to 90. Each set was used for group assignments. The randomization process was organized sequentially with non-repeating numbers across the sets. Participants were assigned to groups according to the order of each set. The randomization process was performed using the Research Randomizer program.

Study Groups

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Control

The injection is administered using the standard method.

Group Type NO_INTERVENTION

No interventions assigned to this group

Helfer Skin Tap Tecnique

After identifying the injection site, the muscles are relaxed by gently tapping the skin with the fingertips of the dominant hand for about five seconds. Using the thumb and index finger of the non-dominant hand, a V shape is formed, and the entire hand is used to tap the skin three times. Simultaneously with the third tap, the needle is inserted into the muscle at a 90-degree angle. After aspiration, the medication is injected over 5 seconds while continuing to gently tap the skin with the fingertips of the non-dominant hand. After administering the medication, the needle is withdrawn from the muscle simultaneously with final tap, while tapping the skin in a V shape using the non-dominant hand.

Group Type EXPERIMENTAL

Helfer Skin Tap Tecnique

Intervention Type BEHAVIORAL

In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the "Individual Identification Form" will be completed.

In the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Following this, tetanus vaccination will be administered to the pregnant women in the intervention group using the Helfer Skin Tap technique in accordance with the "Helfer Skin Tap IM Injection Procedure Guideline".

In the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by the nurse, and the vital signs of the pregnant women will be measured again. To evaluate the long-term effects of pain, participants will be contacted via a link, and pain assessments will be conducted at the 24th and 48th hours following the vaccination.

Local Cold Application

A cold gel compress is removed from the freezer and left at room temperature for a few minutes to thaw slightly. After identifying the injection site, the cold gel compress is wrapped in gauze and placed on the deltoid area to cover the injection site. The cold gel compress is held in place for one minute. After one minute, the cold gel compress is removed. The skin is cleaned with an alcohol swab, then the injection is administered.

Group Type EXPERIMENTAL

Local Cold Application

Intervention Type BEHAVIORAL

In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the "Individual Identification Form" will be completed.

In the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Subsequently, tetanus vaccination will be administered to the pregnant women in the intervention group using a cold compress gel, based on the "Cold Compress Gel IM Injection Procedure Guideline" developed in line with the relevant literature.

In the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by nurse, and the vital signs of the pregnant women will be measured again. Pain assessment will be repeated at the 24th and 48th hours following the vaccination.

Interventions

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Helfer Skin Tap Tecnique

In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the "Individual Identification Form" will be completed.

In the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Following this, tetanus vaccination will be administered to the pregnant women in the intervention group using the Helfer Skin Tap technique in accordance with the "Helfer Skin Tap IM Injection Procedure Guideline".

In the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by the nurse, and the vital signs of the pregnant women will be measured again. To evaluate the long-term effects of pain, participants will be contacted via a link, and pain assessments will be conducted at the 24th and 48th hours following the vaccination.

Intervention Type BEHAVIORAL

Local Cold Application

In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the "Individual Identification Form" will be completed.

In the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Subsequently, tetanus vaccination will be administered to the pregnant women in the intervention group using a cold compress gel, based on the "Cold Compress Gel IM Injection Procedure Guideline" developed in line with the relevant literature.

In the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by nurse, and the vital signs of the pregnant women will be measured again. Pain assessment will be repeated at the 24th and 48th hours following the vaccination.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No