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临床试验/NCT06741059
NCT06741059招募中不适用

Determining the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea

Osmaniye Korkut Ata University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2024年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
93
试验地点
1
主要终点
Transcutaneous Electrical Nerve Stimulation

研究概览

简要总结

The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea

This study aims to investigate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) in managing pain and alleviating menstrual symptoms in individuals with primary dysmenorrhea. Primary dysmenorrhea is characterized by severe menstrual pain and accompanying symptoms that negatively impact the quality of life and daily functioning. TENS, a non-invasive and drug-free method, is applied to relieve pain by stimulating nerves through electrical impulses. This research evaluates the impact of TENS on both the intensity of menstrual pain and associated symptoms, offering insights into its potential as an alternative or complementary therapeutic approach.

详细描述

The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea

Primary dysmenorrhea is a common health problem experienced by women during their menstrual periods, significantly affecting their quality of life. It is often characterized by severe abdominal pain, cramp-like symptoms, nausea, headaches, and fatigue. These symptoms can impact social and functional activities, and in some cases, restrict participation in daily routines.

The treatment of primary dysmenorrhea aims to alleviate symptoms and help women experience a more comfortable menstrual period. Traditional treatments include pain relievers, hormonal therapies, and lifestyle changes. However, these methods may not always be sufficient, or some women may avoid them due to potential side effects.

Transcutaneous Electrical Nerve Stimulation (TENS) has gained popularity in recent years as a non-invasive method for pain management. TENS works by modulating nerve stimulation through low-frequency electrical currents applied to the skin, reducing pain perception. Its potential effectiveness in alleviating menstrual pain has drawn increasing attention as an alternative treatment option.

This study aims to evaluate the effects of TENS on pain and menstrual symptoms in women with primary dysmenorrhea. The research will assess the potential of TENS to reduce menstrual pain and compare its effectiveness with other treatment options. If TENS proves to be effective in managing dysmenorrhea symptoms, it could enhance women's quality of life and provide a valuable non-pharmacological treatment alternative.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Study Design: This study follows a parallel design with three groups:

Experimental Group: Participants in this group receive the active intervention (e.g., Transcutaneous Electrical Nerve Stimulation - TENS).

Placebo Group: Participants in this group receive a placebo treatment (e.g., a sham TENS treatment or a non-active intervention).

Control Group: Participants in this group receive no intervention or the standard treatment.

Blinding: A single-blind design is used in this study, meaning only the participants do not know which group they are assigned to. The research team is aware of the group assignments. This approach helps prevent the participants' expectations from influencing the results.

入排标准

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

入选标准

  • •Aged 18 and above
  • •Have regular menstrual cycles (lasting 3 to 8 days, with a menstrual cycle range of 21 to 35 days)
  • •Have dysmenorrhea pain severity rated 4 or higher on the Visual Analog Scale (VAS)

排除标准

  • •Women with the following conditions were excluded from the study:
  • •Secondary dysmenorrhea
  • •Using oral contraceptives
  • •Having impaired tissue integrity in the abdominal area
  • •Having previous experience with TENS
  • •Having a history of nerve damage or sensory loss
  • •Having a pacemaker
  • •Having any systemic diseases
  • •Being pregnant or in the postpartum period

研究组 & 干预措施

The group receiving the TENS treatment

Experimental

The group has received the TENS treatment.

干预措施: Transkutanöz Elektriksel Sinir Stimülasyonu - TENS (Other)

Placebo Comparator

Placebo Comparator

It is the placebo group where the TENS device is applied, but no treatment is given.

干预措施: Transkutanöz Elektriksel Sinir Stimülasyonu - TENS (Other)

Control Group

No Intervention

It is the control group, which receives no intervention or standard treatment.

结局指标

主要结局

Transcutaneous Electrical Nerve Stimulation

时间窗: 3 months

Transcutaneous Electrical Nerve Stimulation (TENS) is effective in pain management in women with primary dysmenorrhea. The Visual Analog Scale is a scale where the patient can mark their own pain on a ruler that can be used horizontally or vertically, where the pain is evaluated between 0-10. VCS is used to evaluate both the severity of pain and the effectiveness of the treatment/intervention on pain in various populations. An increase in the score indicates an increase in pain.

次要结局

  • Transcutaneous Electrical Nerve Stimulation (TENS) is effective in managing menstrual symptoms in women with primary dysmenorrhea.(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ESRA ÜNAL

Dr

Osmaniye Korkut Ata University

研究点 (1)

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