Acute Coronary Syndromes (ACS)NCT07794358
Effect of Guided Imagery on Sleep Quality, State Anxiety, and Comfort in Patients With Acute Coronary Syndrome
A study testing Guided Imagery in people with Acute Coronary Syndromes (ACS), run by Afyonkarahisar Health Sciences University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes (ACS)
- What is being tested?
- Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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.
- Conditions
- Acute Coronary Syndromes (ACS)
- Being tested
- Guided Imagery
- Keywords
- guided imagery, anxiety, sleep quality, comfort
- Medical subject headings
- Acute Coronary Syndrome, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Day 2 morning and Day 3 morning
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.
Measured: 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)
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.
Measured: Immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÖZNUR GÜRLEK KISACIK, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794358
- Sponsor's protocol ID
- AfyonkarahisarHSU-ÖGKISACIK-1
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07794358
- Acronym / sponsor ID
- AfyonkarahisarHSU-ÖGKISACIK-1
- Conditions
- Acute Coronary Syndromes (ACS)
- Keywords
- guided imagery, anxiety, sleep quality, comfort
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery | Experimental | Behavioral: Guided ImageryParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ImageryParticipants 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. | Behavioural | Guided Imagery |
Primary outcome
Change in State Anxiety as Measured by the State-Trait Anxiety Inventory-State Subscale (STAI-S)
Time frame: 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.
3 secondary outcomes
Sleep Quality as Measured by the Richards-Campbell Sleep Questionnaire (RCSQ)
Time frame: Day 2 morning and Day 3 morning
Change in Comfort as Measured by the General Comfort Questionnaire-Short Form (GCQ-SF)
Time frame: 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)
Time frame: Immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: 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.
Related trials for Acute Coronary Syndromes (ACS)
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Recruiting
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
Not yet recruitingPhase 4
Spontaneous Coronary Artery Dissection - AntipLatelet Therapy Intensity in Guided coNservative Management (SCAD-ALIGN) Trial
SCAD, ACS (Acute Coronary Syndrome)
RecruitingPhase 4
Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery in people with Acute Coronary Syndromes (ACS), run by Afyonkarahisar Health Sciences University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Öznur GÜRLEK KISACIK, Associate Professor (+90 5055659128, oznur.kisacik@afsu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety as Measured by the State-Trait Anxiety Inventory-State Subscale (STAI-S) (time frame: Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.