跳至主要内容
临床试验/NCT05761340
NCT05761340已完成不适用

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

Celal Bayar University2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
To evaluate respiratory rate (per minute) immediately before tetanus vaccine in all women.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Pregnant women meeting the inclusion criteria were assigned to the Helfer skin tap and standard application groups by a computer-based random number generator. The numbers in set 1 were taken to the Helfer skin tap group and the numbers in set 2 to the standard application group by lot method.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

To evaluate respiratory rate (per minute) immediately before tetanus vaccine in all women.

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

次要结局

  • To evaluate respiratory rate (per minute) immediately after tetanus vaccine in all women.(It was implemented 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 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 peripheral oxygen saturation (%) immediately after tetanus vaccine in all women.(It was implemented 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)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验