Effect of Guided Imagery on Sleep Quality, State Anxiety, and Comfort in Patients With Acute Coronary Syndrome
The Effect of Guided Imagery on Sleep Quality, State Anxiety, and Comfort Levels in Patients With Acute Coronary Syndrome Monitored in a Cardiac Intensive Care Unit
The goal of this randomized controlled trial is to determine whether guided imagery, when added to routine care, can reduce state anxiety and improve sleep quality and comfort in adults with acute coronary syndrome who are being treated in a cardiac intensive care unit.
The main questions this study aims to answer are:
Does guided imagery reduce state anxiety compared with routine care alone? Does guided imagery improve sleep quality compared with routine care alone? Does guided imagery improve comfort compared with routine care alone?
A total of 64 participants will be randomly assigned to either a guided imagery group or a routine care group using block randomization.
Participants in the guided imagery group will receive routine care and listen to a standardized guided imagery audio recording through headphones twice a day for two consecutive days. Each guided imagery session will last approximately 15 minutes. Participants in the routine care group will receive the standard treatment and nursing care provided in the cardiac intensive care unit without guided imagery.
Researchers will assess participants' anxiety, sleep quality, and comfort and compare the changes between the two groups.
研究概览
详细说明
Acute coronary syndrome is a serious cardiovascular condition that often requires monitoring and treatment in a cardiac intensive care unit. During intensive care, patients may experience anxiety, sleep disturbance, and reduced comfort because of the acute nature of the illness, the unfamiliar environment, monitoring equipment, noise, interruptions, and ongoing treatment and nursing procedures. Guided imagery is a non-pharmacological mind-body intervention that uses verbal guidance to help individuals focus their attention on calming and relaxing mental images. This study will examine whether adding guided imagery to routine cardiac intensive care can improve patient-reported outcomes in adults with acute coronary syndrome.
This study is designed as a randomized controlled trial with two parallel groups. Eligible participants will be allocated in a 1:1 ratio to either a guided imagery group or a routine care group using block randomization. Participants in both groups will continue to receive the routine medical treatment and nursing care required for their clinical condition.
Participants assigned to the guided imagery group will additionally listen to a standardized guided imagery audio recording through headphones twice daily for two consecutive days. One session will be scheduled during the daytime and one during the evening. Each session will last approximately 15 minutes. The audio recording includes a brief relaxation preparation, attention to natural breathing, visualization of a safe and peaceful environment, and calming sensory imagery. Participants will remain in a clinically appropriate and comfortable position during the intervention and may stop the session at any time if they experience discomfort.
The study will evaluate changes in state anxiety, sleep quality, and comfort over the study period. State anxiety will be evaluated both as an overall patient-reported outcome and, using a brief numerical rating, immediately before and after the guided imagery sessions to explore short-term changes associated with individual sessions. Sleep quality will be assessed after each of the two study nights, and comfort will be assessed before the intervention period and after completion of the two-day study period.
To reduce assessment bias, outcome measurements will be performed by a trained nurse who is independent of the intervention and blinded to group allocation. The study is intended to determine whether guided imagery can be used as a simple, non-pharmacological nursing intervention to support psychological comfort, sleep, and anxiety management in patients with acute coronary syndrome receiving care in a cardiac intensive care unit.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Öznur GÜRLEK KISACIK, Associate Professor
- 电话号码：+90 5055659128
- 邮箱：oznur.kisacik@afsu.edu.tr
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age 18 years or older.
- Diagnosed with acute coronary syndrome, specifically ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI).
- Admitted to and monitored in the cardiac intensive care unit.
- Expected to remain in the cardiac intensive care unit for at least two nights and to be transferred to a ward or discharged after the two-day study period.
- Clinically and hemodynamically stable, with no ongoing or increasing chest pain, significant respiratory distress, unstable vital signs, symptomatic serious arrhythmia, or need for urgent invasive intervention.
- Conscious, oriented to person, place, and time, and able to communicate verbally.
- Able to understand and speak Turkish.
- No hearing impairment that would prevent listening to the guided imagery audio recording through headphones.
- Sufficient cognitive ability to understand and respond to the study questionnaires.
- Willing to participate and able to provide written informed consent.
Exclusion Criteria:
- Diagnosis of unstable angina pectoris.
- Confusion, delirium, or any alteration in consciousness that interferes with communication.
- Diagnosed dementia or cognitive impairment that prevents understanding study instructions.
- Hearing loss that prevents following the audio instructions through headphones.
- Inability to communicate verbally.
- Clinical or hemodynamic instability, including ongoing chest pain, significant dyspnea, hemodynamic instability, symptomatic serious arrhythmia, or need for urgent intervention.
- Receiving invasive mechanical ventilation or respiratory support that interferes with communication.
- Receiving sedative treatment at a level that interferes with consciousness or communication.
- Active psychosis, severe agitation, or an active psychiatric disorder that prevents following the guided imagery instructions.
- Expected cardiac intensive care unit stay of less than two nights.
- Refusal to participate or inability to provide informed consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Guided Imagery
Participants assigned to this arm will receive routine medical treatment and nursing care provided in the cardiac intensive care unit, in addition to guided imagery.
The guided imagery intervention will be delivered using a standardized audio recording through headphones twice daily for two consecutive days.
Each session will last approximately 15 minutes, with one session scheduled during the daytime and one during the evening.
The recording will include relaxation preparation, attention to natural breathing, and visualization of a safe and peaceful environment.
|
Participants assigned to the intervention group will receive guided imagery in addition to routine care.
A standardized guided imagery audio recording will be delivered through headphones twice daily for two consecutive days, with one daytime and one evening session.
Each session will last approximately 15 minutes.
The recording includes relaxation preparation, attention to natural breathing, visualization of a safe and peaceful environment, and calming visual, auditory, and sensory imagery accompanied by low-level nature sounds.
Participants will remain in a comfortable and clinically appropriate position and may stop the session at any time if they experience discomfort.
|
|
无干预：Routine Care
Participants assigned to this arm will receive routine medical treatment and nursing care provided in the cardiac intensive care unit according to their clinical needs.
Routine care may include medical treatment, hemodynamic monitoring, medication administration, pain management, oxygen therapy, basic nursing care, patient education, and standard sleep-supportive care.
Participants in this arm will not receive the guided imagery intervention during the study period.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in State Anxiety as Measured by the State-Trait Anxiety Inventory-State Subscale (STAI-S)
大体时间：Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
|
State anxiety will be assessed using the State-Trait Anxiety Inventory-State Subscale (STAI-S), a 20-item self-report measure of anxiety experienced at the present moment.
The total score ranges from 20 to 80, with higher scores indicating greater state anxiety.
STAI-S will be administered at baseline before the first intervention and again on the morning of Day 3 after completion of the two-day intervention period.
The two measurements will be used to evaluate the effect of guided imagery compared with routine care on state anxiety over the two-day intervention period.
|
Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sleep Quality as Measured by the Richards-Campbell Sleep Questionnaire (RCSQ)
大体时间：Day 2 morning and Day 3 morning
|
Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ).
The overall sleep quality score is calculated as the mean of the first five items, with each item scored from 0 to 100.
The overall score ranges from 0 to 100, with higher scores indicating better perceived sleep quality.
The RCSQ will be administered on the morning of Day 2 to assess sleep quality during the first night and on the morning of Day 3 to assess sleep quality during the second night.
|
Day 2 morning and Day 3 morning
|
|
Change in Comfort as Measured by the General Comfort Questionnaire-Short Form (GCQ-SF)
大体时间：Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
|
Comfort will be assessed using the General Comfort Questionnaire-Short Form (GCQ-SF), a 28-item self-report measure rated on a 6-point Likert scale.
Negatively worded items are reverse scored, and an overall mean score ranging from 1 to 6 is calculated.
Higher scores indicate greater perceived comfort.
The GCQ-SF will be administered at baseline before the first intervention and again on the morning of Day 3 after completion of the two-day intervention period.
The two measurements will be used to evaluate the effect of guided imagery compared with routine care on overall comfort.
|
Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
|
|
Immediate Anxiety as Measured by the Numerical Rating Scale for Anxiety (NRS-A)
大体时间：Immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2
|
Immediate anxiety will be assessed using the Numerical Rating Scale for Anxiety (NRS-A), a single-item self-report measure ranging from 0 to 10.
A score of 0 indicates no anxiety and a score of 10 indicates the most severe imaginable anxiety, with higher scores indicating greater immediate anxiety.
NRS-A will be administered immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2. These pre- and post-session measurements will be used to evaluate the short-term effect of each guided imagery session on immediate anxiety compared with routine care.
|
Immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- AfyonkarahisarHSU-ÖGKISACIK-1
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