The Effect of Dark Chocolate and Cinnamon Sugars on Pain and Anxiety in University Students With Primary Dysmenorrhea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Aim: In this prospective, randomized controlled study, the aim of this study was to investigate the effects of dark chocolate and cinnamon sugar on pain and anxiety in university students with primary dysmenorrhea. Design: The prospective, randomized controlled study
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •University students who had not given birth,
- •Were between the ages of 18 and 25,
- •Had regular menstrual cycles (28±7 days),
- •Had menstrual pain severity of 5 or more on the Visual Analog Scale (VAS) in the previous month,
- •Had primary dysmenorrhea, gave written informed consent,
- •Volunteered to participate in the study were included in the study.
排除标准
- •The study included patients with hearing loss, pelvic pathology, neurological, endocrine or psychiatric disease, and chronic disease such as diabetes mellitus or heart disease, currently taking medication such as antidepressants or oral contraceptives,
- •Menstrual irregularities,
- •University students who had mental problems that prevented evaluation and cooperation, obesity, malignant condition, pelvic surgery, pregnancy, analgesic use, chocolate and cinnamon allergy,
- •Use of any nutritional supplements, medication or non-drug application (reiki, meditation, reflexology, acupressure, etc.) to reduce pain,
- •University students who did not volunteer to participate in the study were excluded.
研究组 & 干预措施
Control
Cinnamon sugar
干预措施: Cinnamon sugar (Behavioral)
Dark chocolate
干预措施: Dark chocolate (Behavioral)
结局指标
主要结局
Visual Analog Scale
时间窗: change from before implamentation patent and after 1st, 2nd, and 3rd months of practice.]
The intensity of menstrual pain will be measured using the VAS, a valid and reliable tool for measuring experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain)
State-Trait Anxiety Inventory
时间窗: change from before implamentation patent and after 1st, 2nd, and 3rd months of practice.
There are 40 items in total under two subheadings as State and Trait Anxiety. The Trait Anxiety Scale determines the individual's predisposition to experience anxiety. In the scale consisting of 20 four-point Likert-type questions, items 1, 6, 7, 10, 13, 16, 19 are reverse items. In this scale, a minimum score of 20 and a maximum score of 80 can be obtained. While a high score indicates a high level of anxiety, a low score indicates a low level of anxiety
次要结局
未报告次要终点
研究者
Burcu KUCUKKAYA
Principal Investigator
Bartın Unıversity