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临床试验/NCT06027489
NCT06027489已完成不适用

The Effect of Listening to Music and Drawing on the Coping With Dysmenorrhea of Nursing Students Experiencing Dysmenorrhea

Trakya University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年7月20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
96
试验地点
2
主要终点
Pain evaluated using the Visual Analog Scale.

研究概览

简要总结

Objectives: Investigating the effects of listening to music and drawing on nursing students with dysmenorrhea on dysmenorrhea complaints is a new and promising area of research. However, high-level evidence on whether listening to music and drawing has an effect on dysmenorrhea complaints is insufficient. The current study addresses this research question..

Design: A three-arm randomized controlled trial was conducted in 96 nursing students with dysmenorrhea.

详细描述

This three-armed randomized controlled study (RCT) will be conducted in July 2023 in Bartın University Faculty of Health Sciences Nursing Department students experiencing dysmenorrhea. Nursing students who experienced dysmenorrhea at the time of application were informed about the aims, setup and intervention of the study. and evaluated for suitability in a short, standardized interview. Nursing students experiencing dysmenorrhea who met our criteria were given a basic questionnaire along with a letter of information and an informed consent form. Nursing students with dysmenorrhea gave written informed consent for participation in the study were included. Evaluations in all three groups were made before randomization (ie baseline) and immediately after the intervention periods (2nd and 3rd month).

Randomization: The randomization list was made by another scientist who was not involved in the research process in order to preserve the random selection order and to prevent bias, and with this blinding applied, the group allocation was hidden. A computer randomization program was used to generate the randomization list for the intervention allocation sequence. Individuals who received a voluntary consent form and volunteered to participate in the research were randomly assigned to the experimental and control groups by using the blocking method. Following simple randomization procedures, participants were assigned to one of the three arms of the study in a 1:1:1 ratio according to a computer-generated randomization scheme via https://www.sealedenvelope.com/simple-randomiser/v1.

In this research, the allocation of participants to groups was made by scientists who were not involved in the research. Due to the nature of the research, the follow-up of the practices and the participants will not be provided during the data collection process, as the researcher does it.

Intervention:

Music Group: In the second and third months, participants listened to a song that lasted 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song to be played was determined by examining the literature, the song was composed by researcher Juan Sebastian Martin-Saavedra and was named Occasio Adolore (Music Piece No. 5-559-355 and Phonogram No. 12-105-295) by the author copyright institution of Colombia. registered under. While the researcher is composing the song, it is to create a piece of music that will reduce the pain felt, activate positive emotions and relax the person. The composed song is available online within the scope of the published article (https://soundcloud.com/jss-martin/occasio-adolore). Written permission was obtained from Juan Sebastian Martin-Saavedra to use the composed song in the research. The access link of the composed song will be sent to the participants via social media (WhatsApp). After listening to music for three days before the menstrual cycle and on the first day of menstruation (for a total of four days), pain, menstrual symptoms and perceived stress on the first day of menstruation will be measured using VAS, MSS, and PSS, respectively.

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

入选标准

  • Has not given birth,
  • The ages of 18-25,
  • Having a regular menstrual cycle (28±7 days),
  • Menstrual pain severity in the previous month is 5 or higher on the Visual Analogue Scale (VAS),
  • Having dysmenorrhea,
  • Having their written consent,
  • Nursing students who volunteered to participate in the study

排除标准

  • Hearing loss
  • Having chronic disease such as pelvic pathology, neurological, endocrine or psychiatric disease and diabetes mellitus or heart disease,
  • Currently using drugs such as antidepressants or oral contraceptives,
  • Havingmenstrual irregularity,
  • Having mental problems that prevent evaluation and cooperation,
  • Obesity, malignant condition, pelvic surgery, pregnancy,
  • Using analgesics,
  • Using medication or non-drug practices (reiki, meditation, reflexology, acupressure, etc.),
  • Nursing students who did not volunteer to participate in the study

结局指标

主要结局

Pain evaluated using the Visual Analog Scale.

时间窗: change from before implamentation patent and after 2. and 3. month of practice.

The intensity of pain is 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).

Mensruation symptom evaluated using the Menstruation Symptom Scale (MSS).

时间窗: change from before implamentation patent and after 2. and 3. month of practice.

This scale was developed in English by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. It is a widely used scale in the United States and many different countries. In 2009, Negriff et al. The factor structure and usability on adolescents were reassessed and updated. The adaptation of the scale to Turkish was done by Güvenç et al. in 2014. Participants are asked to give a number between 1 (never) and 5 (always) for the symptoms they experience about menstruation. Cronbach's Alpha value is 0.86. It is a five-point Likert-type scale consisting of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions. The increase in the mean score for the sub-dimensions indicates that the severity of menstrual symptoms related to that sub-dimension increases.

Perceive stress evaluated using the Perceived Stress Scale (PSS).

时间窗: change from before implamentation patent and after 2. and 3. month of practice.

This scale is a self-rating scale developed by Cohen, Kamarck, and Mermelstein (1983). The total score that can be obtained from the scale is 32. A high total score from the scale, which consists of 10 items and scored between 0-4, indicates a high level of stress. In this study, the scale whose Turkish validity and reliability study was conducted by Bilge, Öğce, Genç, and Oran (2009) was used.

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

Burcu KUCUKKAYA

Assist. Prof

Bartın Unıversity

研究点 (2)

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