The Effect of Cognitive-Behavioral Therapy on Perceived stress and Sleep Quality among Patients undergoing Percutaneous Coronary Intervention referring to Shafa Hospital 2019
Design
Clinical trial study with control group with parallel, randomized, non-blinded groups،The sample size is 40 patients.
Settings and conduct
After obtaining written informed consent from the patient and providing the necessary information about the goals of the study, basic information about perceived stress and quality of sleep is taken from patients in both groups. Intervention after the first visit to the clinic and receiving the authorization from the trained physician under the supervision of a clinical psychologist in the rehabilitation clinic of Shafa hospital in groups of 5 to 6 persons. Control group patients received only routine medical intervention during this period. .
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients undergoing percutaneous coronary intervention; Ability to speak Persian;Aged 18 years and up
Exit criteria:Cognitive problems such as Alzheimer's disease, stroke;Hearing and visual impairment that prevents communication;Presence of psychiatric disorder;Taking antidepressants and anti-anxiety drugs;Taking sleeping pills and sedative medications;The presence of mental disorders which requiring immediate treatment (symptoms of psychiatry, substance dependency, suicide)
Intervention groups
Patients in the intervention group are receiving cognitive-behavioral intervention in addition to receiving the usual medical care, but the patients in the control group receive only the usual medical intervention during this period.
Main outcome variables
Perceived stress and Sleep Quality of patients with Percutaneous Coronary Intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190725044329N1
Registration date:2019-09-07, 1398/06/16
Registration timing:registered_while_recruiting
Last update:2019-09-07, 1398/06/16
Update count:0
Registration date
2019-09-07, 1398/06/16
Registrant information
Name
Marziyeh Salimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 6766
Email address
salim.mp97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-22, 1398/05/31
Expected recruitment end date
2019-11-20, 1398/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive-Behavioral Therapy on Perceived Stress and Sleep Quality among Patients undergoing Percutaneous Coronary Intervention
Public title
The Effect of Cognitive-Behavioral Therapy on Perceived Stress and Sleep Quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing Percutaneous Coronary Intervention
Aged 18 years and up
Ability to speak Persian
Exclusion criteria:
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)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Beginning of the axis of Haft Bagh Alavi, Campus of Medical Sciences
Before, immediately and one month after the intervention
Method of measurement
Cohen Perceived Stress Questionnaire
2
Description
Sleep quality
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Behavior
2
Description
Control group: Patients in the control group receive only the usual medical intervention during this period.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Marzieh Salimpour
Street address
Kosar Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
shafahospital@kmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas pardakhty
Street address
Research and Technology Dept. - Research Manager, Ibn Sina Ave.Tahmasebad Crossroad,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Web page address
http://vcrt.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Marziyeh Salimpour
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shafa hospital, end of the Shafa street, Jomhori boulvard
City
Kerman
Province
Kerman
Postal code
7617894593
Phone
+98 34 3211 5813
Fax
Email
salim.mp97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Parvin Mangolian Shahrbabaki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Kerman University of Medical Sciences,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Fax
+98 34 3132 5218
Email
mangolian167@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Marziyeh Salimpour
Position
Senior Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
salim.mp97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD