The Effect of Listening to Music and Making Puzzles in Cope With Dysmenorrhea in Young Women: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Menstrual Pain Severity
研究概览
简要总结
The aim of this clinical trial is to evaluate whether interventions such as listening to music and doing puzzles are effective in reducing menstrual pain, menstrual symptoms, and perceived stress in young women with dysmenorrhea, ages 18-25.
The main questions it aims to answer are:
Do listening to music and doing puzzles reduce dysmenorrhea pain? Do these interventions affect menstrual symptoms and perceived stress? The researchers will compare music, puzzle, and control groups to assess the effects on pain intensity, menstrual symptoms, and perceived stress levels.
Participants:
Participants will be followed for three menstrual cycles, In the first cycle, pain, symptoms, and stress levels will be measured,
In the next two cycles:
Music group: Listen to a specific song with headphones for four days, Puzzle group: Do puzzles for the same amount of time, Control group: Measurements only, without intervention.
详细描述
Objective:This study aimed to determine the effects of listening to music and doing puzzles on coping with dysmenorrhea in young women.
Method The study is a single-center, double-blind, prospective, three-parallel-group randomized controlled trial conducted at a university health school. Participants will be followed for three menstrual cycles. In the first menstrual cycle, menstrual pain, menstrual symptoms, and perceived stress level scales will be administered. In the second and third menstrual cycles, two interventions, doing puzzles and listening to music, will be administered.
A randomization method will be used to assign participants to music, puzzles, or control groups, ensuring that extraneous variables are equally distributed. Blinding procedures will be applied for both participants and researchers to control for bias and confounding factors. Intervention protocols will be standardized to ensure consistency. Inclusion and exclusion criteria were carefully defined to control for variables that could affect the validity of the study.
Universe and Sample/Study Group (The path to be followed in creating the sample and study group should be explained.) The universe of the study will consist of all female students studying at a university's health school, meeting the criteria for inclusion in the study, and agreeing to participate in the study.
The study sample will consist of female students who meet the criteria for inclusion in the study and agree to participate in the study between the dates of the study. The sample size will be calculated by performing a power analysis with the G power program and by taking a study as a reference. It was determined that 28 people from each group would be sufficient to participate in the study with an effect size of 0.75, α = 0.05 margin of error, and minimum power = 80% (β = 0.2%). However, considering possible missing data, it was decided to include 32 female students in the study with a 10% increase in each group.
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
- None
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
- •Female students studying at a university health college
- •Female students between the ages of 18 and 25
- •Female students with a Visual Analog Scale (100 mmVAS) pain intensity of 5 or higher
- •Female students with regular menstrual cycles (28 ± 7 days) within the past year
- •Female students without endocrine, neurological, or chronic diseases such as pelvic pathology, hearing loss, diabetes, and heart disease
- •Female students without psychiatric illnesses or mental health problems that would interfere with evaluation and cooperation
- •Female students who are not using oral contraceptives or antidepressants
- •Female students who have not had pelvic surgery
- •Female students who have not had malignant diseases
- •Female students who are not obese
- •Female students who have not previously been pregnant
- •Female students who have not received advanced musical training
- •Female students who are not taking vitamin supplements
排除标准
- •Female students who do not meet the inclusion criteria
- •Female students who use medication, non-drug practices (acupressure, Reiki, reflexology, meditation), or any nutritional supplements to reduce pain
结局指标
主要结局
Menstrual Pain Severity
时间窗: Through study completion, an average of 3 mounts
Menstrual pain intensity will be assessed using the 100 mm Visual Analog Scale (VAS). Participants will rate their pain by marking a point on a 10 cm horizontal line ranging from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate more severe pain.
次要结局
- Menstrual Symptom Severity(Through study completion, an average of 3 mounts)
- Perceived Stress Level(Through study completion, an average of 3 mounts)
研究者
ENDAM ÇETİNKAYA AK
Assistant Professor
Burdur Mehmet Akif Ersoy University