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Clinical Trials/NCT05532605
NCT05532605
Recruiting
Not Applicable

Effects of Mindfulness Based Therapy on Patients Perception of Illness and Depression in Cardiac Rehabilitation Phase-i

Riphah International University1 site in 1 country48 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Stenosis
Sponsor
Riphah International University
Enrollment
48
Locations
1
Primary Endpoint
Illness perception questionnaire
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

A randomize controlled trial will be conducted at Punjab institute of cardiology hospital Lahore, through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and Group B. Pretreatment values of patients' blood pressure, RR, HR, will be recorded. And patient's perception of illness through Illness Perception Questionnaire (IPQ), PHQ9 for depression assessment and HRQOL for quality of life will be assessed before and after treatment. Group A will be treated with basic Phase-I cardiac rehabilitation. And Group B will be treated with basic Phase-I cardiac rehabilitation along with Mindfulness based therapy. Treatment evaluation will be done after 8 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.

Detailed Description

Cardiac rehabilitation is becoming more widely acknowledged as an important part of the overall treatment plan for individuals with cardiovascular disease. Cardiac rehabilitation programs aim to reduce the physiological and psychological impacts of heart disease. Anxiety, depression, cardiovascular disease, and suicide are among poor health outcomes of stress, which is a global public health issue. Depression, a disorder with a significant psychological burden, has been linked to an increased risk of cardiovascular disease. Although the exact nature of the links between depression and coronary heart disease (CHD) has yet to be determined, these links are increasingly being highlighted. The aim of the study is to find Effects of Mindfulness based therapy on patient perception of illness and depression in cardiac rehabilitation Phase-I. A randomize controlled trial will be conducted at Punjab institute of cardiology hospital Lahore, through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and Group B. Pretreatment values of patients' blood pressure, RR, HR, will be recorded. And patient's perception of illness through Illness Perception Questionnaire (IPQ), PHQ9 for depression assessment and HRQOL for quality of life will be assessed before and after treatment. Group A will be treated with basic Phase-I cardiac rehabilitation. And Group B will be treated with basic Phase-I cardiac rehabilitation along with Mindfulness based therapy. Treatment evaluation will be done after 8 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
January 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Phase-I CABG
  • Hypertensive patients
  • Patients hemodynamically stable

Exclusion Criteria

  • Hemodynamically unstable patients
  • Orthopedic conditions i.e. fracture
  • Disorientated patients
  • Neuromuscular disease
  • pacemaker dependency
  • Uncontrolled arrhythmias
  • Red Flags Like: Fever, Night Sweats, Malaise

Outcomes

Primary Outcomes

Illness perception questionnaire

Time Frame: 4 months

The model proposes that situational stimuli (such as symptoms) generate both cognitive and emotional representations of the illness or health threat. These representations are processed in parallel through three stages. 0 is minimum and 10 is maximum.

PHQ9 for depression assessment

Time Frame: 4 months

The Patient Health Questionnaire-9 (PHQ-9) is a nine-item questionnaire used in primary care and other medical settings to assess for depression. and The conventional cut-off score for detecting suspected major depression is 10 or higher. The Brief IPQ is a frequently used questionnaire with excellent psychometric qualities

Secondary Outcomes

  • HRQOL for quality of life(4 months)

Study Sites (1)

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