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临床试验/NCT06973252
NCT06973252已完成不适用

The Effect of Eye Mask on Sleep Quality in Patients Hospitalised in Surgical Intensive Care Unit: Non-Randomised Experimental Study

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年11月15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
发起方
入组人数
64
试验地点
1
主要终点
Sleep status

研究概览

简要总结

It is thought that transferring low-cost and easily applicable interventions that can be used to control environmental stressors such as noise and light that negatively affect sleep quality, especially in intensive care environments, into clinical practice will improve the quality of nursing care. It is recommended that complementary interventions that can be used to improve such sleep quality should be tested and supported by new studies. In this study, it was aimed to determine the effect of eye mask on sleep quality in patients admitted to the surgical intensive care unit after abdominal surgery.

详细描述

Sleep is one of the basic needs to maintain and protect health and is a physiological state that occurs as a result of loss of consciousness, slowing of muscle activities, and decrease in neural activity for a certain period of time. Sleep quality is adversely affected as a result of physiological or psychological factors occurring in the perioperative period or disruptions in normal sleep phases due to environmental factors such as light and noise in the intensive care environment. Especially in surgical intensive care units (SICU), it is one of the units where deterioration in the sleep quality of patients is frequently experienced.

It is reported that improving sleep quality in intensive care units will support the recovery processes of patients in the clinical environment and shorten the duration of hospital stay. Non-pharmacological methods are frequently used in patients hospitalised in the intensive care unit. In the literature, there are research results on the positive effects of using eye patch and earplugs, listening to audio books, massage and aromatherapy, acupressure, music therapy, white noise application, reflexology massage and foot bath interventions on sleep quality.

Sleep is an important component of nursing management in surgical intensive care units and is one of the basic needs of patients. Surgical nurses who provide nursing care here should plan, implement and evaluate environmental arrangements and non-pharmacological interventions to improve the sleep quality of patients. Especially interventions such as eye mask can be used to control the environmental factor that negatively affects sleep quality in surgical intensive care units. In systematic reviews and meta-analyses on the method of sleep in intensive care unit patients, it is reported that the use of eye mask improves sleep quality, but more studies are needed to increase the quality of evidence. It is thought that transferring low-cost and easily applicable interventions that can be used to control environmental stressors such as noise and light that negatively affect sleep quality, especially in intensive care environments, into clinical practice will improve the quality of nursing care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
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
否

入选标准

  • •had undergone abdominal surgery
  • •over 18 years of age,
  • •who speak Turkish,
  • •who have not received any diagnosis related to mental health,
  • •who are open to communication and co-operation
  • •Patients who voluntarily agreed to participate in the study

排除标准

  • •patients with a history of neurological or psychiatric disorders
  • •patients with any eye disease
  • •patients who are unable or unwilling to wear an eye mask

研究组 & 干预措施

Intervention group

Experimental

The intervention group patients were fitted with an eye mask designed by the researcher by placing a black fabric in the size of the mask between two three-layer surgical masks with Asfor brand soft elastic earphones and stapling the edges. The designed eye mask was cut with scissors according to the shape of the nose so that the mask would fit the eye exactly and prevent the light from entering the eye. A separate mask was used for each patient in the intervention group. Patients who were admitted to the SICU after surgery were evaluated for agitation-pain-delirium at 23:00 on postoperative days 0, 1, and 2, were told to wear their eye masks after the scale application, and the patients were allowed to sleep at 23:00 at the latest. Patients were allowed to remove the eye patch for short periods of time (10 minutes or less at a time) and then put it back on when uncomfortable and when necessary.

干预措施: Eye masks (Behavioral)

Control group

No Intervention

Control group received the usual care.

结局指标

主要结局

Sleep status

时间窗: On the 3rd postoperative day

This form was developed by the researcher using the literature on the subject. The form was filled in based on the self-report of the patients. In order to determine the sleep status of the patients, the form included 5 statements: 'I feel tired and sleepy during the day despite sleeping for a sufficient amount of time', 'I have difficulty falling asleep 2-3 nights a week', 'I have to constantly move my legs in bed', 'I have to go to the toilet at least once during the night', 'I wake up tired and with a headache in the morning'.

Richmond Agitation Sedation Scale (RASS) Score

时间窗: Postoperative 1st, 2nd and 3rd days

It is a ten-level scale developed by Cook and Palma (1989) in which eye contact, which is not present in other scales, is evaluated following the verbal stimulus. In the scale, a score of '0' indicates the ideal level where the patient is awake and calm, while values up to '+4' reflect increasing agitation and values up to '-5' reflect increasing sedation level. As the scale score increases, it is interpreted as the agitation status of the patients worsens.

Richard-Campbell Sleep Scale (RCS) Score

时间窗: Postoperative 1st, 2nd and 3rd days

Richard-Campbell Sleep Scale (RCS): In 1987, the Turkish validity and reliability study of the scale was conducted by Richards in 2015 by Özlü and Özer. The scale consists of 6 items evaluating sleep quality, depth of sleep at night, frequency of awakening, ambient sound level, time of staying awake and time to fall asleep. Each item is evaluated on a scale ranging from 0 to 100. A score between '0-25' indicates very poor sleep and a score between '76-100' indicates very good sleep. As the scale score increases, patients' It is interpreted that sleep quality has increased.

次要结局

未报告次要终点

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezgi Arslan

PhD, Research Assisstant (Principal Investigator)

Aydin Adnan Menderes University

研究点 (1)

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