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

Pain Clinical Trial

Official title:

The Effect of Helfer Skin Tap Technique on Pain Reduction and Hemodynamic Parameters During Tetanus Injection in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05761340
• Other study ID #: Celal Bayar University
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: February 2023
• Source: Celal Bayar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Tetanus

Intervention

Procedure:
• Helfer skin tap injection technique
Place the patient in a seated position and open his right arm to inject into the deltoid muscle. 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. 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. During the third stroke, prick the syringe into the muscle at 90 degrees angle at the same time. 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. 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 Injection technique
Place the patient in a seated position and open his right arm to inject into the deltoid muscle area. After determining the injection site, prepare the skin with alcohol. 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. After aspiration, inject the drug with the dominant hand at a rate of 1 ml /10 seconds. Remove the syringe needle 10 seconds after the drug is consumed

Locations

Country	Name	City	State
Turkey	Manisa Celal Bayar University	Manisa

Sponsors (1)

Lead Sponsor	Collaborator
Celal Bayar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the pregnant women's demographics and clinical backgrounds.	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.	It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.
Primary	To evaluate peripheral oxygen saturation (%) immediately before tetanus vaccine in all women.	Peripheral oxygen saturation (%) were evaluated immediately before tetanus vaccine administration in all women.	It was implemented immediately before tetanus vaccine administration in all women.
Primary	To evaluate heart rate (per minute) immediately before tetanus vaccine in all women.	Heart rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.	It was implemented immediately before tetanus vaccine administration in all women.
Primary	To evaluate respiratory rate (per minute) immediately before tetanus vaccine in all women.	Respiratory rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.	It was implemented immediately before tetanus vaccine administration in all women.
Primary	To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately before tetanus vaccine in all women.	Systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) were evaluated immediately before tetanus vaccine administration in all women.	It was implemented immediately before tetanus vaccine administration in all women.
Secondary	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.	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.	It was implemented immediately after Tetanus vaccine that was administered using the Helfer skin tap techniques
Secondary	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.	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.	It was implemented immediately after Tetanus vaccine that was administered using the the Standart intramuscular injection techniques
Secondary	To evaluate peripheral oxygen saturation (%) immediately after tetanus vaccine in all women.	Peripheral oxygen saturation (%) were evaluated immediately after tetanus vaccine administration in all women.	It was implemented immediately after tetanus vaccine administration in all women
Secondary	To evaluate heart rate (per minute) immediately after tetanus vaccine in all women.	Heart rate (per minute) were evaluated immediately after tetanus vaccine administration in all women.	It was implemented immediately after tetanus vaccine administration in all women
Secondary	To evaluate respiratory rate (per minute) immediately after tetanus vaccine in all women.	Respiratory rate (per minute) were evaluated immediately after tetanus vaccine administration in all women.	It was implemented immediately after tetanus vaccine administration in all women
Secondary	To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately after tetanus vaccine in all women.	Systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) were evaluated immediately after tetanus vaccine administration in all women.	It was implemented immediately after tetanus vaccine administration in all women