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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Öznur GÜRLEK KISACIK, Associate Professor
- Número de teléfono: +90 5055659128
- Correo electrónico: oznur.kisacik@afsu.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in State Anxiety as Measured by the State-Trait Anxiety Inventory-State Subscale (STAI-S)
Periodo de tiempo: Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
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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.
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Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sleep Quality as Measured by the Richards-Campbell Sleep Questionnaire (RCSQ)
Periodo de tiempo: Day 2 morning and Day 3 morning
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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.
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Day 2 morning and Day 3 morning
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Change in Comfort as Measured by the General Comfort Questionnaire-Short Form (GCQ-SF)
Periodo de tiempo: Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
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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.
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Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
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Immediate Anxiety as Measured by the Numerical Rating Scale for Anxiety (NRS-A)
Periodo de tiempo: Immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2
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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.
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Immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
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Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Desordenes mentales
- Enfermedades cardíacas
- Trastornos del sueño y la vigilia
- Trastornos del Sueño Intrínsecos
- Disomnias
- Isquemia miocardica
- Desórdenes de ansiedad
- Trastornos de iniciación y mantenimiento del sueño
- El síndrome coronario agudo
- Terapéutica
- Terapias de la mente-cuerpo
- Terapias complementarias
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Imágenes, psicoterapia
Otros números de identificación del estudio
- AfyonkarahisarHSU-ÖGKISACIK-1
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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