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IRCT20190725044329N1 IRCT 2019-09-07 Kerman University of Medical Sciences The Effect of Cognitive-Behavioral Therapy on Perceived Stress and Sleep Quality The Effect of Cognitive-Behavioral Therapy on Perceived Stress and Sleep Quality among Patients undergoing Percutaneous Coronary Intervention 2019-08-22 anticipated 40 Complete https://irct.ir/trial/41116 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization which the patient was the randomization unit. Assignment of patients to the intervention and control group is carried out by a statistical expert by using blocks of 4 with the help of statistical software Minitab and using random numbers. N/A Patients undergoing Percutaneous Coronary Intervention. Intervention 1: Intervention group: Patients in the intervention group receive cognitive-behavioral intervention along with routine medical care for 4 weeks and 2 sessions per week. Intervention is performed by trained researcher based on packages prepared by clinical psychologist in rehabilitation clinic of Shafa hospital in groups of 5-6 persons.Session One: References and brief explanations about stress management and its impact on coronary artery disease and treatment modalities, especially coronary interventions through the skin. Session 2: Understanding the Importance, Awareness of the Physical and Psychological Impacts of Stress, and the Importance of Managing and Monitoring Stress Levels and Creating a List of Stressors(Resting exercises). Session 3: Understanding the Relationship between Thoughts, Emotions, and the Evaluation Learning Process) Diaphragmatic Respiratory Exercise) Identifying Different Types of Negative Thoughts, Understanding Negative Impact on Behavior) Imaging Exercises as Imaging (, Identifying Logical and Irrelevant Self-talk, Learning Steps) Replacing Logical Thoughts (Calming Exercises as Imaging with Diaphragmatic Breathing.Session 4: Learn Coping Types Identify your own coping style, effective coping or ineffective) Relaxation exercises as visualized with diaphragmatic breathing (, learning and practicing effective coping steps, softening exercises for overwhelming stressors) As a positive self-induction visualization (, learn anger management. Session 5: Learn Interpersonal Styles, Expressive Communication Practice, and Use Problem Solving Skills) Perform Breathing Counting Meditation Exercises (and Understand the Benefits of Social Support Identify Barriers to Social Support Learn stress management techniques for social support and coping (coping exercises) Imaging face with diaphragmatic breathing). Session 6: Assessing Sleep Problem, Understanding Sleep and Insomnia, Thought Assessment, Calm Training and Homework (Sleep Calendar and Constructive Concerns Worksheet). New sleep hygiene and timing, sleep restriction, daily snooze, food hygiene and homework (sleep calendar and constructive worries). Session Seven: Problem Solving Skills, Summarizing Thoughts, Reality of Sleep, Brainstorming, Emotional Training, Mental Imagery, Tranquility, and Unnecessary Trying to Sleep (Antonyms Intention) Pre-assignments (Sleep Calendar and Constructive Concerns Worksheet) and outline the entire Cognitive-Behavioral Therapy Plan, Sleep Health, Behavioral and Cognitive Interventions.Eighth Session: The Three Sides of Past Meetings. Intervention 2: Control group: Patients in the control group receive only the usual medical intervention during this period. No - There is not a plan to make this available Justification or reason for not sharing IPD is Failure to complete the plan
public Marziyeh Salimpour
Shafa hospital, end of the Shafa street, Jomhori boulvard
Kerman Iran (Islamic Republic of) 7617894593 +98 34 3211 5813 salim.mp97@gmail.com Kerman University of Medical Sciences scientific Parvin Mangolian Shahrbabaki
Faculty of Nursing and Midwifery, Kerman University of Medical Sciences,
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5220 mangolian167@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Patients undergoing Percutaneous Coronary Intervention Aged 18 years and up Ability to speak Persian 18 years no limit Both Cognitive problems such as Alzheimer's disease, stroke Hearing and visual impairment that prevents communication Presence of psychiatric disorders Taking antidepressants and anti-anxiety drugs Taking sleeping pills and sedative medications Having psychiatric disorders requiring immediate treatment (symptoms of psychiatry, drug dependence, suicide) Behavior Behavior Intervention group: Patients in the intervention group receive cognitive-behavioral intervention along with routine medical care for 4 weeks and 2 sessions per week. Intervention is performed by trained researcher based on packages prepared by clinical psychologist in rehabilitation clinic of Shafa hospital in groups of 5-6 persons.Session One: References and brief explanations about stress management and its impact on coronary artery disease and treatment modalities, especially coronary interventions through the skin. Session 2: Understanding the Importance, Awareness of the Physical and Psychological Impacts of Stress, and the Importance of Managing and Monitoring Stress Levels and Creating a List of Stressors(Resting exercises). Session 3: Understanding the Relationship between Thoughts, Emotions, and the Evaluation Learning Process) Diaphragmatic Respiratory Exercise) Identifying Different Types of Negative Thoughts, Understanding Negative Impact on Behavior) Imaging Exercises as Imaging (, Identifying Logical and Irrelevant Self-talk, Learning Steps) Replacing Logical Thoughts (Calming Exercises as Imaging with Diaphragmatic Breathing.Session 4: Learn Coping Types Identify your own coping style, effective coping or ineffective) Relaxation exercises as visualized with diaphragmatic breathing (, learning and practicing effective coping steps, softening exercises for overwhelming stressors) As a positive self-induction visualization (, learn anger management. Session 5: Learn Interpersonal Styles, Expressive Communication Practice, and Use Problem Solving Skills) Perform Breathing Counting Meditation Exercises (and Understand the Benefits of Social Support Identify Barriers to Social Support Learn stress management techniques for social support and coping (coping exercises) Imaging face with diaphragmatic breathing). Session 6: Assessing Sleep Problem, Understanding Sleep and Insomnia, Thought Assessment, Calm Training and Homework (Sleep Calendar and Constructive Concerns Worksheet). New sleep hygiene and timing, sleep restriction, daily snooze, food hygiene and homework (sleep calendar and constructive worries). Session Seven: Problem Solving Skills, Summarizing Thoughts, Reality of Sleep, Brainstorming, Emotional Training, Mental Imagery, Tranquility, and Unnecessary Trying to Sleep (Antonyms Intention) Pre-assignments (Sleep Calendar and Constructive Concerns Worksheet) and outline the entire Cognitive-Behavioral Therapy Plan, Sleep Health, Behavioral and Cognitive Interventions.Eighth Session: The Three Sides of Past Meetings Control group: Patients in the control group receive only the usual medical intervention during this period. Perceived Stress. Timepoint: Before, immediately and one month after the intervention. Method of measurement: Cohen Perceived Stress Questionnaire. Sleep quality. Timepoint: Before, immediately and one month after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Kerman University of Medical Sciences Approved 2019-06-25 Ethics Committee of Kerman University of Medical Sciences Beginning of the axis of Haft Bagh Alavi, Campus of Medical Sciences Kerman Kerman Iran (Islamic Republic of)