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

NCT06976632 | Recruiting DMC

• 1 other identifier: 20.478.486/2967
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant Women

Keywords

immunization; pain; hemodynamic parameters; pregnant women; local cold application; helfer skin tap tecnique

Outcome Measures

Primary Outcomes (2)

• Individual Identification Form

  The "Individual Identification Form," which includes the sociodemographic characteristics of the pregnant women, was developed by the researchers based on the relevant literature. The form consists of 9 questions.

  It was implemented on the first day of the study.

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

  Pain assessment related to the injection in pregnant women will be conducted using the Numerical Pain Scale immediately after the injection, 15 minutes later, and at the 24th and 48th hours. It is based on the principle that patients circle the number representing the amount of pain they experience on a 10 cm horizontal scale, with "No Pain" written at the far left and "Severe Pain" at the far right. When evaluating pain intensity, a score of 0 indicates "No pain," 1-3 points indicate "Mild pain," 4-6 points indicate "Moderate pain," and 7-10 points indicate "Severe pain."

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

Secondary Outcomes (4)

• Monitoring the systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) of the pregnant women

  before the injection, immediately after the injection, and 15 minutes after the injection

• Monitoring the heart rate (per minute) of the pregnant women

  before the injection, immediately after the injection, and 15 minutes after the injection

• Monitoring the respiratory rate (per minute) of the pregnant women

  before the injection, immediately after the injection, and 15 minutes after the injection

• Monitoring the peripheral oxygen saturation (%) of the pregnant women

  before the injection, immediately after the injection, and 15 minutes after the injection

Study Arms (3)

Control

NO INTERVENTION

The injection is administered using the standard method.

Helfer Skin Tap Tecnique

EXPERIMENTAL

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.

Behavioral: Helfer Skin Tap Tecnique

Local Cold Application

EXPERIMENTAL

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.

Behavioral: Local Cold Application

Interventions

Helfer Skin Tap Tecnique 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.

Helfer Skin Tap Tecnique

Local Cold Application 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.

Local Cold Application

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Individuals over the age of 18 who have received the tetanus vaccine due to pregnancy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Manisa Celal Bayar University

Manisa, Uncubozköy/Yunusemre, 45030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sevgi Pakiş Çetin, Asst. Prof.

  Celal Bayar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevgi PAKİŞ ÇETİN, Asst. Prof.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 16, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): June 9, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Starting 6 months after publication.
• Access Criteria: It can be shared upon request, if the relevant ethics committee approves.

Locations

TU (1)