Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, and Health-related Quality of Life in Adults With a Stoma: A Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Self-care non-pharmacological methods can help reduce the negative health effects of sleep problems or insomnia. This trial aims to investigate the effects of sleep hygiene education and lavender oil inhalation alone and in combination on sleep quality, fatigue, and health-related quality of life in adults with a stoma.
详细描述
This study has been planned as a randomized controlled clinical trial and will use a 2x2 factor design in which an equal number of participants meeting the inclusion criteria will be randomly allocated to one of four groups. The study population will comprise 120 adult patients who have undergone ostomy surgery in a city hospital in Turkey. Lavender oil inhalation together with sleep hygiene education will be applied in the first group (n=30), only sleep hygiene education in the second group (n=30), only lavender oil inhalation in the third group (n=30), and no intervention in the fourth group (n=30). The sleep quality of the groups will be evaluated using the Pittsburgh Sleep Quality Index, their fatigue levels with the Chalder Fatigue Scale, and their quality of life with the Stoma Quality of Life Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older,
- •At least three months having passed after ostomy,
- •Having a clear level of consciousness and no disease or medication use that can negatively affect the level of consciousness,
- •Being able to communicate in Turkish,
- •Providing informed written consent to participate in the study.
排除标准
- •Lavender allergy,
- •Respiratory tract infections such as sinusitis and pneumonia,
- •Body mass index (BMI) of >40,
- •A diagnosis of sleep disorder and/or medication use for sleep problems.
研究组 & 干预措施
Group 3 (Lavender oil inhalation)
The participants assigned to Group 3 will only be instructed on how to apply lavender oil inhalation and keep regular daily records on the chart given. The participants in this group will be given lavender oil in a 10 ml bottle.
干预措施: Lavender oil inhalation (Behavioral)
Group 4 (Routine care)
Participants assigned to Group 4 will be given routine care and no application will be made.
Patient care and follow-up are routinely performed as follows: Following the patient's admission to the clinic, the first evaluation of the patient is made by the ostomy and wound care nurses within 24 hours, and patient education is initiated accompanied by the primary caregiver from the family. Throughout the period from admission to clinic to discharge, the ostomy care and education of the patient is repeated by the ostomy and wound care nurses every 72 hours. In addition, the patient and caregiver are given the contact information of the ostomy and wound care nurses and informed that they can call them at any time when they need it after discharge from the hospital.
Group 1 (Sleep hygiene education together with lavender oil inhalation)
the participants assigned to Group 1 will be given sleep hygiene education and instructed how to apply lavender oil inhalation. The participants will be provided with charts on sleep hygiene education and lavender oil inhalation and shown how to regularly keep daily records using their charts. The participants in this group will be given a copy of the sleep hygiene education brochure and lavender oil in a 10 ml bottle.
干预措施: Lavender oil inhalation (Behavioral)
Group 1 (Sleep hygiene education together with lavender oil inhalation)
the participants assigned to Group 1 will be given sleep hygiene education and instructed how to apply lavender oil inhalation. The participants will be provided with charts on sleep hygiene education and lavender oil inhalation and shown how to regularly keep daily records using their charts. The participants in this group will be given a copy of the sleep hygiene education brochure and lavender oil in a 10 ml bottle.
干预措施: Sleep hygiene education (Behavioral)
Group 2 (Sleep hygiene education)
The participants assigned to Group 2 will only be given sleep hygiene education. They will be provided with a copy of the sleep hygiene education brochure and a chart on which to record their sleep hygiene practices.
干预措施: Sleep hygiene education (Behavioral)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: a month
. It consists of seven subscales with a total of 19 items, of which 18 are included in scoring. Each item is evaluated over 0-3 points, and the sum of the seven subscale scores constitutes the total PSQI score. The total score that can be obtained from the scale ranges from 0 to 21, and a high total score indicates poor sleep quality. A total PSQI score of ≤5 indicates 'good sleep', and a score of \>5 indicates 'poor sleep'.
Chalder Fatigue Scale (CFS)
时间窗: a month
The scale consists of 11 items, seven evaluating physical fatigue and four evaluating mental fatigue. There are four options for response to the items in the scale (less than usual, no more than usual, more than usual, and much more than usual). The overall fatigue score is obtained by summing the scores in the physical and mental fatigue subscales. The physical fatigue subscale score ranges from 0 to 21, the mental fatigue subscale score ranges from 0 to 12, and the total fatigue score ranges from 0 to 33. An increase in the scale score indicates an increase in the severity of fatigue.
Stoma Quality of Life Scale (SQLS)
时间窗: a month
The remaining items are grouped into three subscales: work/social life (six items), sexuality/body image (five items), and stoma function (six items). In addition, there is one item related to the economic situation and one item related to skin irritation, which do not fall into any of the previously mentioned subscales. Minimum and maximum scores for each subscale are 0 and 100, respectively, with high scores indicating an increase in quality of life. If two items in any subscale are left unanswered in the scale, the relevant subscale is not taken into consideration during scoring, but if one item is left unanswered, it can be included in evaluation.
次要结局
未报告次要终点