跳至主要内容
临床试验/NCT05829538
NCT05829538进行中(未招募)不适用

The Effect of Sujok and Massage on Pain and Quality of Life in Women With Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Study

Halic University2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2022年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
2
主要终点
Menstrual Pain VAS

研究概览

简要总结

A single-blind randomized controlled study was conducted with female students studying at a foundation university. Women who met the sample selection criteria were randomized into three groups, 40 women in each group, a total of 120 women: Su Jok (A), Massage (B), and Control Group (C). Data were obtained by applying the Data Collection Form, the Visual Analogue Scale (VAS), the Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale, and the SF-36 Quality of Life Scale to the women followed for three menstrual cycles.

详细描述

This study was performed in a single-blind, randomized controlled type to examine the effect of Su Jok and massage on pain and quality of life in women with primary dysmenorrhea.The sample size in this study was G*Power 3.1.9.2. In the program, 5% first type error, 0.30 standardized effect size, 1:1 distribution ratio, 80% power, and the minimum sample size required for the three groups were calculated as 111 women and 37 women for each group. Considering that there may be losses, 40 women and a total of 120 women were randomized to each group.

"Data Collection Form", "Visiual Analog Scale (VAS)", "Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale", "SF-36, Quality of Life Scale" were used to obtain data.Intervention and Data Collection Stage 1: VAS was applied to the women who volunteered to participate in the study on the first day of menstruation, and women with a mean score of 5 and above and meeting the sample selection criteria were randomized into three separate groups as A, B, and C. The researcher who performed the randomization ensured that the women were assigned to the control and experimental groups and did not share this information with the other researchers. Data Collection Form, Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale, SF-36 Quality of Life Scale were applied to all women on the first day of the next menstruation. Since the data collection tools were based on self-report, the woman was allowed to answer in a calm environment and alone. The environment where the applications will be held was arranged in such a way that the researcher and the participant could sit opposite each other with two chairs and an application table. Entry and exit to the room was prevented until the application was over. The environment was quiet.

Stage 2 Su Jok Experimental Group (A): In this study, the seed therapy technique was applied using live buckwheat seeds. Hands were used because it was reported in the literature that hands were used for gynecological pain and were more suitable.The acupuncture point, which is the reflection of the painful area, was determined on the women's hands. This point was massaged for a few minutes by the researcher, and then the buckwheat seed was fixed to this point with a bandage and the area where the seed was applied was massaged for 30 minutes. After each application, VAS evaluation was taken from the women. Su Jok was applied to women in the first three days of menstruation for three cycles.Experimental Group (B) to whom massage was applied: Massage application determined by scanning the literature and taking expert opinion classical massage techniques (eufluorage, petrissage, friction, tapotman, vibration) was used. Massage was attempted for a total of 20 minutes, 10 minutes on the back and waist, and 10 minutes on the abdominal region, in the first three days of the three cycles. Massage application was started from the back and waist region. Efflorage, petrissage, friction, vibration, taputman and efflorage for one minute were applied to this area, respectively. Afterwards, three minutes of efflorage, petrissage, friction, and one-minute efflorage were applied to the abdominal region, respectively. Odorless, lubricating gel was used during the application. After each application, VAS evaluation was taken from the women. Massage was applied to the women in the first three days of menstruation for three cycles.

Control Group (C): VAS assessment was obtained for the first three days during three cycles.

Stage 3 Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale and SF-36 Quality of Life Scale were applied to all women included in the study on the third day of the third cycle.

研究设计

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

盲法说明

In the study, the women were blind to each other in terms of practice and the data evaluator was blinded to the groups in the study in terms of analysis and reporting. Su Jok and massage application and follow-up were carried out by the researcher (FŞB), who could not be blinded to the applications. Randomization was done by another researcher (ZN). In order to avoid bias, the investigator (FSB) did not participate in any step of the pre-test, post-test and statistical evaluation process.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Not diagnosed with chronic and mental illness,
  • Not using hormonal contraceptives and analgesics,
  • Not having a pregnancy history, d) having regular menstrual cycles in the last 6 months (bleeding between 3-8 days and 21-35 days)
  • Verbal Women who stated that they had dysmenorrhea
  • 18-35 years old g) Women who defined menstrual pain as 5 or higher according to the Visual Analogue Scale (VAS) were included.

排除标准

  • Dysmenorrhea and a gynecological diagnosis,
  • Regular exercise, massage and Su Jok practices were not included.

结局指标

主要结局

Menstrual Pain VAS

时间窗: 12 Weeks

The effect of the intervention on menstrual pain was measured by VAS

Affected by dysmenorrhea

时间窗: 12 Weeks

Measured with the Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale

次要结局

未报告次要终点

研究者

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

Fatma Şule Bilgiç

Lecturer

Halic University

研究点 (2)

Loading locations...

相似试验