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

NCT ID: NCT05761340

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2022-03-30

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.

Conditions

Intramuscular Injection; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Helfer Skin Tap Group

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

Group Type: EXPERIMENTAL

Helfer skin tap injection technique

Intervention Type: PROCEDURE

1. Place the patient in a seated position and open his right arm to inject into the deltoid muscle.

2. After determining the injection site, use the tips of the dominant hand fingers to hit the skin (about 15 strokes) for about five seconds to soften the muscles.

3. After cleaning the skin with alcohol, remove the syringe cover from the dominant hand. Make a V with the non-dominant hand and hit the skin three times.

4. During the third stroke, prick the syringe into the muscle at 90 degrees angle at the same time.

5. After aspiration, continue to hit the skin with the tips of the non-dominant hand fingers while injecting the drug with the dominant hand at a rate of 1 ml / 10 seconds.

6. After injecting the drug, make the non-dominant hand V-shaped and hit the skin three times, pulling the syringe needle out at the same time during the third stroke

Standard Application Group

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.

Group Type: EXPERIMENTAL

Standard Injection technique

Intervention Type: PROCEDURE

1. Place the patient in a seated position and open his right arm to inject into the deltoid muscle area.

2. After determining the injection site, prepare the skin with alcohol.

3. Grasp the skin with the thumb and index finger of the non-dominant hand and prick the syringe into the muscle at a 90-degree angle.

4. After aspiration, inject the drug with the dominant hand at a rate of 1 ml /10 seconds.

5. Remove the syringe needle 10 seconds after the drug is consumed

Interventions

Helfer skin tap injection technique

1. Place the patient in a seated position and open his right arm to inject into the deltoid muscle.

2. After determining the injection site, use the tips of the dominant hand fingers to hit the skin (about 15 strokes) for about five seconds to soften the muscles.

3. After cleaning the skin with alcohol, remove the syringe cover from the dominant hand. Make a V with the non-dominant hand and hit the skin three times.

4. During the third stroke, prick the syringe into the muscle at 90 degrees angle at the same time.

5. After aspiration, continue to hit the skin with the tips of the non-dominant hand fingers while injecting the drug with the dominant hand at a rate of 1 ml / 10 seconds.

6. After injecting the drug, make the non-dominant hand V-shaped and hit the skin three times, pulling the syringe needle out at the same time during the third stroke

Intervention Type: PROCEDURE

Standard Injection technique

1. Place the patient in a seated position and open his right arm to inject into the deltoid muscle area.

2. After determining the injection site, prepare the skin with alcohol.

3. Grasp the skin with the thumb and index finger of the non-dominant hand and prick the syringe into the muscle at a 90-degree angle.

4. After aspiration, inject the drug with the dominant hand at a rate of 1 ml /10 seconds.

5. Remove the syringe needle 10 seconds after the drug is consumed

Intervention Type: PROCEDURE

Other Intervention Names

Helfer Skin Tap Group; Standard Application Group

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Celal Bayar University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aslı Karakuş Selçuk, PhD

Role: PRINCIPAL_INVESTIGATOR

Manisa Celal Bayar University

Locations

Manisa Celal Bayar University

Manisa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Celal Bayar University

Identifier Type: -

Identifier Source: org_study_id