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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAfyonkarahisar Health Sciences University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Guided ImageryExperimental treatment 1 intervention
Group B: Routine CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period

Secondary outcomes

1

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

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.

Time frame
Day 2 morning and Day 3 morning
2

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

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.

Time frame
Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
3

Immediate Anxiety as Measured by the Numerical Rating Scale for Anxiety (NRS-A)

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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