ClinicalTrials.gg
Not yet recruitingNCT07794358Updated Aug 31, 2026

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

An interventional study of Guided Imagery in Acute Coronary Syndromes (ACS), sponsored by Afyonkarahisar Health Sciences University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Afyonkarahisar Health Sciences University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

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.

02

Conditions studied

  • Acute Coronary Syndromes (ACS)

Keywords

  • guided imagery
  • anxiety
  • sleep quality
  • comfort
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's planned enrollment of 64 is below the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Afyonkarahisar Health Sciences University is the lead sponsor of 115 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • 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.

    Behavioral: Guided Imagery

  • No intervention
    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.

Interventions

  • BehavioralGuided Imagery

    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.

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — No formal plan has been established to share individual participant data (IPD) with other researchers. Individual participant data will not be made publicly available. Study findings will be reported in aggregate form to protect participant privacy and confidentiality.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07794358
Responsible party
ÖZNUR GÜRLEK KISACIK (Associate Professor, Afyonkarahisar Health Sciences University) — Principal investigator
First posted
Aug 31, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 31, 2026

Study contacts

Öznur GÜRLEK KISACIK, Associate Professor
Contact
oznur.kisacik@afsu.edu.tr
+90 5055659128

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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