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临床试验/NCT06991660
NCT06991660已完成不适用

The Effect of Sleep Hygiene Education Given in Line With the Health Promotion Model on Sleep Quality and Menopausal Symptoms

Inonu University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Pittsburgh Sleep Quality Index

研究概览

简要总结

Health promotion is defined as the behaviors that a person exhibits for a long-term and high-standard life. Health promotion creates a sense of health in the individual, which makes the person feel more energetic and happy. The health promotion model primarily aims to treat the disease in the person. If the individual does not have a disease, their health is further improved. Sleep is one of the basic needs required for a person to continue their life in a healthy way. Some behaviors of people affect the quality and order of sleep. Sleep hygiene is the daily activities performed to improve the quality of sleep during sleep. Sleep hygiene education aims to avoid personal behaviors that affect a healthy sleep order and to exhibit behaviors that will positively affect sleep. Menopause is defined as the permanent cessation of the menstrual cycle as a result of the ovaries losing their activity. Menopause is one of the important stages of a woman's life. Some physical and psychological changes begin to occur in women who lose their fertility and enter menopause. These changes are generally called menopausal symptoms. These symptoms are; menstrual irregularity, hot flashes, sleep disorders, tension and depression, etc. The research was planned as an experimental pre-test and post-test, and the data will be collected before and after the face-to-face training given by the researcher. The effects of sleep hygiene training given in line with the health promotion model on sleep have been investigated in the literature, but no study has been found examining the effects of sleep hygiene training given in line with the health promotion model on sleep hygiene and menopausal symptoms of women in menopause. Therefore, it is thought that the research will contribute to the literature. The results obtained as a result of the study regarding the effects of sleep hygiene training given on sleep hygiene and menopausal symptoms will be taken into consideration by midwives.

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
45 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Not having menstrual bleeding for at least 12 consecutive months
  • •Not having difficulty communicating
  • •Using a mobile phone
  • •Being literate
  • •Not using sleeping pills
  • •Not taking any supplements to sleep.

排除标准

  • •Menstrual bleeding during the research period
  • •The participant wants to talk about his/her research.

研究组 & 干预措施

training group

Experimental

First interview: This interview, which was held at the ASM, included meeting the women in the intervention group, applying the pre-test data, explaining the purpose of the training, and determining the training location (ASM, the participant's home, etc.).

Second interview: One week after the first interview, at the appointed location (ASM and the participant's home), the "Sleep Hygiene Training" prepared according to the individual characteristics - experiences and behavior-specific cognitive processes and behavioral outputs that are the components of the SGM was carried out, the "Sleep Diary" was introduced, the "Sleep Hygiene Training Booklet" and the "Sleep Diary" were distributed.

Third interview: One week after the second interview, the repeat training, which constitutes the second session of the training, was carried out.

Fourth interview: Obtaining the post-test data 4 weeks after the second interview.

The researcher reminded the participants about the sleep diary via text

干预措施: sleep hygiene education (Behavioral)

control group

No Intervention

A total of two interviews were conducted with women in the control group who were not given any intervention. In the first interview, pre-test data were obtained using the Personal Introduction Form, MSDS and PSQI. In the interview held 6 weeks after the first interview, post-test data were obtained using MSDS and PSQI. Each interview lasted an average of 15-20 minutes.

结局指标

主要结局

Pittsburgh Sleep Quality Index

时间窗: first day encountered

It was developed by Buysse et al. (1989) to assess sleep quality. It was adapted to Turkish by Ağargün et al. in 1996. The PSQI assesses the quality of an individual's sleep in the last month. While the individual answers 19 of the 24 questions in the PSQI, 5 questions are expected to be answered by the spouse or a roommate. The last 5 questions are directed only to the individual's relative in terms of clinical aspects and are not included in the scoring. The last of the questions asked as self-report questions is whether the individual has a roommate or spouse; this question is not used in the evaluation of the PSQI. There are different factors related to sleep quality in the self-report questions. The 18 items included in the scoring are divided into groups as 7 component scores. Some of the components are shown with only one item, while the other results in the classification of several items. Each component in the questions is worth 0-3 points.

Menopausal Symptoms Assessment Scale

时间窗: first day encountered

MSDÖ, developed by Schneider and colleagues in German to determine the level of menopause experienced by women, was translated and adapted into Turkish by Gürkan in 2005. The Likert-type scale consists of a total of 11 items covering menopausal complaints. Each item has three sub-dimensions, with the options 0: none at all, 1: mild, 2: moderate, 3: severe and 4: very severe. These are; 1. Somatic symptoms sub-dimension: items 1, 2, 3, 11 2. Psychological symptoms sub-dimension: items 4, 5, 6, 7 3. Urogenital symptoms sub-dimension: items 8, 9, 10. The total score of the scale is calculated according to the scores given to each item. The lowest score on the scale is 0, and the highest score is 44. A high total score calculated at the end of the scale indicates that the participant has many complaints and that their standard of living is negatively affected.

次要结局

  • pittsburg sleep index(up to 4 weeks after registration)
  • Menopausal Symptoms Assessment Scale(up to 4 weeks after registration)

研究者

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

Elif Yıldırım

principal investigator

Inonu University

研究点 (1)

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