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

27 août 2026 mis à jour par: ÖZNUR GÜRLEK KISACIK, Afyonkarahisar Health Sciences University

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

64

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Guided 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.
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in State Anxiety as Measured by the State-Trait Anxiety Inventory-State Subscale (STAI-S)
Délai: 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.
Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Sleep Quality as Measured by the Richards-Campbell Sleep Questionnaire (RCSQ)
Délai: Day 2 morning and Day 3 morning
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.
Day 2 morning and Day 3 morning
Change in Comfort as Measured by the General Comfort Questionnaire-Short Form (GCQ-SF)
Délai: Baseline (Day 1, before the first intervention) and Day 3 morning after completion of the two-day intervention period
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.
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)
Délai: Immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2
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.
Immediately before and within 5 minutes after each daytime and evening session on Days 1 and 2

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Afyonkarahisar Health Sciences University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 novembre 2026

Achèvement primaire (Estimé)

30 juin 2027

Achèvement de l'étude (Estimé)

30 juin 2027

Dates d'inscription aux études

Première soumission

14 août 2026

Première soumission répondant aux critères de contrôle qualité

27 août 2026

Première publication (Réel)

31 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AfyonkarahisarHSU-ÖGKISACIK-1

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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