Effect of Guided Imagery on Sleep Quality, State Anxiety, and Comfort in Patients With Acute Coronary Syndrome

NCT07794358 | Not Yet Recruiting

• 1 other identifier: AfyonkarahisarHSU-ÖGKISACIK-1
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Coronary Syndromes (ACS)

Keywords

guided imagery; anxiety; sleep quality; comfort

Outcome Measures

Primary Outcomes (1)

• Change in State Anxiety as Measured by the State-Trait Anxiety Inventory-State Subscale (STAI-S)

  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

Secondary Outcomes (3)

• Sleep Quality as Measured by the Richards-Campbell Sleep Questionnaire (RCSQ)

  Day 2 morning and Day 3 morning

• Change in Comfort as Measured by the General Comfort Questionnaire-Short Form (GCQ-SF)

  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)

  Immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2

Study Arms (2)

Guided Imagery

EXPERIMENTAL

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.

Behavioral: Guided Imagery

Routine Care

NO INTERVENTION

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.

Interventions

Guided Imagery BEHAVIORAL

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.

Guided Imagery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

MeSH Terms

Conditions

Acute Coronary Syndrome; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Öznur GÜRLEK KISACIK, Associate Professor

CONTACT

+90 5055659128; oznur.kisacik@afsu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share