The Effect of Helfer Skin Tap Technique During Tetanus Injection in Pregnant Women

Not Applicable

Completed

• Conditions: Pain; Intramuscular Injection
• Interventions: Procedure: Standard Injection technique; Procedure: Helfer skin tap injection technique

• Registration Number: NCT05761340
• Lead Sponsor: Celal Bayar University

Brief Summary

Intramuscular (IM) vaccination administered using the right injection technique is known to cause less pain and injury. Nurses employ different approaches like applying pressure, tapping the skin, cold and hot applications for reducing the pain caused by the IM vaccine administration. Helfer skin tap is among the techniques that relax muscles.

The aim of the study was to determine the effect of Helfer skin tap technique on pain reduction and hemodynamic parameters during tetanus injection in pregnant women. This study was conducted on pregnant women who applied to the Family Health Center to get a tetanus vaccine. The Helfer skin tap and standard application groups each included 33 and 32 pregnant women, respectively.

Detailed Description

In 1988, Joanne Helfer developed the "Helfer Skin Tap Technique" which is applied by touching the skin over the injection site and attempted to reduce the intramuscular injection-related pain. In this technique, after determining the injection site, nearly 15 strokes are made on the skin for almost five seconds using the fingertips of the dominant hand in order to soften the muscles. Later, the skin is cleaned with alcohol, the non-dominant hand is put in V shape and the skin is hit three times. During the third stroke, the syringe is pricked into the muscle with a 90-degree angle at the same time. Making a few taps relaxes the muscles and counting to three helps synchronizing the muscle tap and injection and standardizes the technique. Mechanical stimulation of muscle fibers of larger diameters decreases the effect of smaller, pain generating fibers. According to the gate control theory suggested by Roger Metzack and Past Wall (1965), in addition to a mechanical stimulation during an IM injection, this technique also causes distraction, which, in turn, helps reducing pain.

The study aimed to determine the effect of Helfer skin tap technique on pain reduction and hemodynamic parameters during tetanus injection in pregnant women. This study was a randomized clinical trial conducted in Manisa Soma Family Health Center in Turkey. The study was conducted with 65 pregnant women who got tetanus vaccine. Tetanus vaccine was administered using the Helfer skin tap techniques to 33 of the pregnant women and standard IM injection technique to 32 women. The pain was evaluated immediately after vaccination and hemodynamic parameters were examined before and immediately after the vaccine.

Study Timeline

• Study Start: 2021-08-30
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Study First Submitted: 2023-01-25
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

• over the age of 18
• being pregnant,
• having no infection, scar tissue, or incision, and receiving parenteral treatment in their injection area
• having no history of pain in their injection are
• applying for tetanus vaccine
• speaking Turkish
• voluntariness.

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Exclusion Criteria

• under the age of 18
• not being pregnant
• having a vaccination other than tetanus,
• having pain or a local infection prior to vaccination,
• having a circulatory disorder, peripheral vascular disease,
• cognitive and psychological problems,
• using painkillers at least 6 hours before the procedure,
• refusing to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Application Group	Standard Injection technique	Pregnant women were vaccinated against tetanus with thestandard application technique.The pain was evaluated with Number rating scale. The pain was evaluated immediately after vaccination and hemodynamic parameters were examined before and after the vaccination. A total of 32 pregnant women completed the study in the standard application group.
Helfer Skin Tap Group	Helfer skin tap injection technique	Pregnant women were vaccinated against tetanus with the Helfer skin tap technique.The pain was evaluated with Number rating scale immediately after the procedure and also hemodynamic parameters were measured before and after the vaccination. A total of 33 pregnant women completed the study in the Helfer skin tap group

Primary Outcome Measures

Name	Time	Method
To evaluate respiratory rate (per minute) immediately before tetanus vaccine in all women.	It was implemented immediately before tetanus vaccine administration in all women.	Respiratory rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.
To evaluate peripheral oxygen saturation (%) immediately before tetanus vaccine in all women.	It was implemented immediately before tetanus vaccine administration in all women.	Peripheral oxygen saturation (%) were evaluated immediately before tetanus vaccine administration in all women.
To evaluate heart rate (per minute) immediately before tetanus vaccine in all women.	It was implemented immediately before tetanus vaccine administration in all women.	Heart rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.
Description of the pregnant women's demographics and clinical backgrounds.	It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.	Questions about the pregnant women's descriptive characteristics such as age, education and employment status, Body Mass Index, smoking status, number of children and pregnancy, having intramuscular injection and any problem after intramuscular injection, and number of tetanus injection were asked using the questionnaire.
To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately before tetanus vaccine in all women.	It was implemented immediately before tetanus vaccine administration in all women.	Systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) were evaluated immediately before tetanus vaccine administration in all women.

Secondary Outcome Measures

Name	Time	Method
To evaluate respiratory rate (per minute) immediately after tetanus vaccine in all women.	It was implemented immediately after tetanus vaccine administration in all women	Respiratory rate (per minute) were evaluated immediately after tetanus vaccine administration in all women.
To evaluate the pain level in the Standart intramuscular injection group with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.	It was implemented immediately after Tetanus vaccine that was administered using the the Standart intramuscular injection techniques	To evaluate the pain level immediately after Tetanus vaccine that was administered using the the Standart intramuscular injection with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.
To evaluate the pain level in the Helfer skin tap group with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.	It was implemented immediately after Tetanus vaccine that was administered using the Helfer skin tap techniques	To evaluate the pain level immediately after Tetanus vaccine that was administered using the Helfer skin tap technique with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.
To evaluate peripheral oxygen saturation (%) immediately after tetanus vaccine in all women.	It was implemented immediately after tetanus vaccine administration in all women	Peripheral oxygen saturation (%) were evaluated immediately after tetanus vaccine administration in all women.
To evaluate heart rate (per minute) immediately after tetanus vaccine in all women.	It was implemented immediately after tetanus vaccine administration in all women	Heart rate (per minute) were evaluated immediately after tetanus vaccine administration in all women.
To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately after tetanus vaccine in all women.	It was implemented immediately after tetanus vaccine administration in all women	Systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) were evaluated immediately after tetanus vaccine administration in all women.

Trial Locations

Locations (1)

Manisa Celal Bayar University; 🇹🇷 Manisa, Turkey