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临床试验/NCT06744023
NCT06744023已完成不适用

The Effect of Improved Envıronment Accordıng to Watson's Theory of Human Care on Sleep, Anxıety, and Depressıon ın Patıents Undergoıng Open Heart Surgery: A Randomızed Controlled Study

Hatice AZİZOĞLU1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10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
试验地点
1
主要终点
Improved sleep quality with optimised environment

研究概览

简要总结

The aim of this randomized controlled trial was to examine the effect of an improved environment on sleep, anxiety, and depression in patients undergoing open heart surgery. This study aims to answer the following main questions:

  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' sleep level and sleep quality?
  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' anxiety and depression levels?

In order to observe the effect of the improved environment on sleep, anxiety, and depression, the researchers ensured that the room temperature, humidity, and lumen range of the light were at the appropriate level in the first 3 days after the surgery of the patients in the experimental group and gradually decreased them gradually.

详细描述

The aim of this randomized controlled trial was to examine the effect of an improved environment on sleep, anxiety, and depression in patients undergoing open heart surgery. This study aims to answer the following main questions:

  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' sleep level and sleep quality?
  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' anxiety and depression levels? Before collecting data for this study, the "G. Power-3.1.9.2" program calculated the sample size at an 80% confidence level. The "Sample Calculation Formula with Known Universe (Population Volume)" (n = Nz2pq / d2(N-1) + z2pq) determined the sample. The literature review determined the "effect size" value to be 0.096. Taking the primary type error of 5% (Z = 1,96), the test power of 80%, and the effect size value of 0,096 units, we calculated the minimum sample size as n = 60. Therefore, the study included 60 volunteer patients, with 30 placed in the experimental group and 30 in the control group.

Data were collected using the Personal Information Form, the Richard-Campbell Sleep Questionnaire (RCSQ), and the Hospital Anxiety and Depression (HAD) Scale.

The patients who underwent open heart surgery and who were in the experimental group were admitted to the ward from the postoperative intensive care unit and the environment was improved for three days based on the improved environment of Watson's HCT, and on the morning of the fourth day in the clinic, the patients were interviewed face to face and the Personal Information Form, RSCQ and HAD Scale were completed. The following improvements were implemented within the scope of environmental improvement:

  • Considering the seasonal conditions, the patient room was ensured to have appropriate temperature (18-26 °C) and humidity values (30-60%), and the temperature and humidity were gradually reduced and maintained in the appropriate range by monitoring at 21:00, 22:00, and 23:00 (Days 1, 2, and 3).
  • In line with the environmental arrangements, the brightness of the light in the patient room was gradually reduced at 21:00, 22:00, and 23:00 using the Light Meter LM-3000 (Days 1, 2, and 3).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients between the ages of 18 and 65 who have undergone open heart surgery and who are conscious and willing to communicate and cooperate.

排除标准

  • Patients younger than 18 years and older than 65 years who did not want to participate in the study voluntarily

结局指标

主要结局

Improved sleep quality with optimised environment

时间窗: The first three days after transfer from intensive care to the ward

This outcome measure assesses how the improved environment affects postoperative sleep quality with the Richard-Campbell Sleep Questionnaire (RCSQ).

Improvement in anxiety levels with improved environment

时间窗: The first three days after transfer from intensive care to the ward

This outcome measure assesses how the improved environment affects postoperative anxiety with the Hospital Anxiety and Depression (HAD) Scale.

Improvement in depression levels with improved environment

时间窗: The first three days after transfer from intensive care to the ward

TThis outcome measure assesses how the improved environment affects postoperative depression with the Hospital Anxiety and Depression (HAD) Scale.

次要结局

未报告次要终点

研究者

发起方
Hatice AZİZOĞLU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hatice AZİZOĞLU

Assistant Professor

Yuzuncu Yıl University

研究点 (1)

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