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临床试验/NCT04413188
NCT04413188已完成不适用

Effect of Warm Foot Bath on Their Sleep Quality and Comfort Level in Elderly Individuals: A Randomized-controlled Trial

T.C. ORDU ÜNİVERSİTESİ0 个研究点目标入组 60 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Dailiy sleep quality: The Numerical Rating Scale (NRS)

研究概览

简要总结

Objectives: To determine the effectiveness of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems.

Design and methods: This study was a randomized controlled trial. A total of 217 elderly individual who stayed in two nursing homes. The sample consisted of 60 elderly individuals with sleep problem who were randomly assigned to either the warm foot bath group (n= 30) and control group (n=30).The study was completed with 60 elderly individuals. The primary outcome was an information questionnaire, the Pittsburgh Sleep Quality Index, the General Comfort Questionnaire and the Numerical Rating Scale.

详细描述

The age pyramid of the world population is changing, and as it does so, the percentage of elderly people is rapidly increasing. As one advances in age, it has been found that they tend to sleep latency later, have reduced time spent within crucial rapid eye movement (REM) sleep, and have reduced total duration and quality of sleep and sleep-related problems start to occur. The National Sleep Foundation The national sleep federation recommends 7-8 hours of sleep per day for the elderly. However, many elderly report that they sleep less than recommended and have difficulty sleep latency.

Sleeping is a significant action that affects individuals' daily lives as well as their quality of life. Sleep is required to meet the basic needs of daily life and comprises physiological, psychological, environmental and sociocultural dimensions. Sleep quality, which has been considered as increasingly significant in recent years, can be defined as feeling physically-fit, refreshed, and ready for a new day when waking up. Sleep quality consists of several quantitative aspects and measurements of sleep itself, such as the duration before sleep latency, the duration of sleep, the number of times a person wakes up in the night, as well as more subjective aspects such as the depth of sleep and the relaxing characteristic of sleep.

Such sleep-related problems may negatively affect an individual's comfort. Comfort is a basic need that comprises one of the cornerstones of holistic nursing care practice. Accordingly, solving sleep-related problems, increasing sleep quality, and ensuring comfort for the individuals concerned will require comprehensive nursing care. Pharmacological methods are the most commonly used approach in trying to resolve sleep-related problems. However, these methods have been insufficient as they do not provide a complete solution for sleep-related problems. Additionally, the side effects of these methods, which are obligatory for the affected individuals, are numerous, and this has paved the way for the development of non-pharmacological treatment methods. Relevant literature indicates methods such as eye masks, music therapy, massages, alternative and supplementary therapies, aromatherapy, and warm foot bath have all been successfully used to solve sleep-related problems among elderly people, thereby boosting their sleep quality and comfort.

Warm foot bath causes peripheral vasodilation and decreases core body temperatures. A negative relationship was found between core body temperature and inclination to sleep. Individuals' sleep latency decreases when body core temperature decreases thus, individuals' sleep quality and comfort level are increased. Warm foot bath as a non-pharmacological methods is a more practical and less expensive approach when compared with others.

The relevant literature demonstrated that the number of studies examining sleep quality and comfort among elderly people was limited. The literature included some studies that examined the use of relaxation exercises, back-massage practices, aromatherapy, and music therapy to improve sleep quality and comfort. However, the number of studies examining the effect of warm foot bath on sleep quality was found to be limited . The purpose of the trial was to investigate the effect of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems. Our primary hypothesis was that the sleep quality of the intervention group would be better after 6 weeks than the control group. The secondary hypotheses were that the comfort levels of the intervention group would be better after 6 weeks than the control group

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 (Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 years and up
  • relative independent in daily life activities
  • having a PSQI score of 5 or more
  • no communication problems.

排除标准

  • who used sleeping drugs or diuretic drugs
  • had peripheral artery diseases
  • neurological diseases.

结局指标

主要结局

Dailiy sleep quality: The Numerical Rating Scale (NRS)

时间窗: Daily for six weeks

The Numerical Rating Scale (NRS) This scale was prepared as a form incorporating a scale; it was then used by individuals who were able to mark and assess their personal sleep quality each day. The NRS asks patients to choose the number from 0 to 10 that best represents their sleep with 0 representing a poor night's sleep, and 10 representing a good night's sleep.

Comfort level

时间窗: six weeks after the first foot bath

The General Comfort Questionnaire (GCQ) This questionnaire was developed by Katharine Kolcaba in 1992 to determine individuals' comfort needs and evaluate nursing interventions that might be employed to ensure and increase such comfort. The GCQ uses a four-point Likert type scale and consists of 48 items. The lowest score that can be obtained from the scale is 48, the highest score is 192. The total score obtained from the scale was divided by 48 (the number of the items in the scale) to determine the score's mean value which was presented as a score between one and four. The GCQ was adapted for use in a Turkish context by Kuguoğlu and Karabacak in 2004. The Cronbach's alpha coefficient of the original scale was 0.88; in the study by Kuguoglu and Karabacak, it was 0.85. The present study derived a Cronbach's alpha coefficient of 0.68 prior to experimental and 0.75 after experimental.

Sleep quality: Pittsburgh Sleep Quality Index (PSQI)

时间窗: six weeks after the first foot bath

The Pittsburgh Sleep Quality Index (PSQI) This index was developed by Buysse and colleagues to evaluate individuals' sleep quality and sleeping disorders over a month. The scale consists of 24 items, 19 of these items are related to self-reporting and are answered by the respondents. This is composed of 19 questions which reflect seven major components. The last five items of the index (11a, 11b, 11c, 11d, and 11e) are answered by the partners or roommates of the participants, and these items are not included in the scoring. Each item is scored with points ranging from 0 to 3, with 0 indicating a "good" score and 3 indicating a "poor" score. Accordingly, higher total scores indicate poor sleep quality; scores of 0-4 indicate good sleep quality, and scores of 5-21 suggest poor sleep quality

次要结局

未报告次要终点

研究者

发起方
T.C. ORDU ÜNİVERSİTESİ
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanife DURGUN

Principal Investigator

T.C. ORDU ÜNİVERSİTESİ

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