Clinical trial NCT05761340: The Effect of Helfer Skin Tap Technique During Tetanus Injection in Pregnant Women
Official title: The Effect of Helfer Skin Tap Technique on Pain Reduction and Hemodynamic Parameters During Tetanus Injection in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intramuscular Injection
Pain
Keywords: Intramuscular Injection
Pain
Helfer Skin Tap Technique
Hemodynamic parameters
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Description of the pregnant women's demographics and clinical backgrounds.
timeFrame: It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.
measure: To evaluate peripheral oxygen saturation (%) immediately before tetanus vaccine in all women.
timeFrame: It was implemented immediately before tetanus vaccine administration in all women.
measure: To evaluate heart rate (per minute) immediately before tetanus vaccine in all women.
timeFrame: It was implemented immediately before tetanus vaccine administration in all women.
measure: To evaluate respiratory rate (per minute) immediately before tetanus vaccine in all women.
timeFrame: It was implemented immediately before tetanus vaccine administration in all women.
measure: To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately before tetanus vaccine in all women.
timeFrame: It was implemented immediately before tetanus vaccine administration in all women.
Secondary outcomes:
measure: 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.
timeFrame: It was implemented immediately after Tetanus vaccine that was administered using the Helfer skin tap techniques
measure: 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.
timeFrame: It was implemented immediately after Tetanus vaccine that was administered using the the Standart intramuscular injection techniques
measure: To evaluate peripheral oxygen saturation (%) immediately after tetanus vaccine in all women.
timeFrame: It was implemented immediately after tetanus vaccine administration in all women
measure: To evaluate heart rate (per minute) immediately after tetanus vaccine in all women.
timeFrame: It was implemented immediately after tetanus vaccine administration in all women
measure: To evaluate respiratory rate (per minute) immediately after tetanus vaccine in all women.
timeFrame: It was implemented immediately after tetanus vaccine administration in all women
measure: To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately after tetanus vaccine in all women.
timeFrame: It was implemented immediately after tetanus vaccine administration in all women
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
Study officials:
affiliation: Manisa Celal Bayar University
name: Aslı Karakuş Selçuk, PhD
role: PRINCIPAL_INVESTIGATOR
References: