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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05532605
Other study ID # Sonia Ilyas
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date January 1, 2023

Study information

Verified date December 2022
Source Riphah International University
Contact Wajeeha Zia, PP-DPT
Phone 0323 4500788
Email wajeeha.zia@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Other:
cardiac rehabilitation phase I protocols
cardiac rehab phase I protocols: ankel pumps, limbs ROMs, bed mobility. Do 5-10 minutes daily of breath awareness practice on your own.
Cardiac rehab phase I protocols + Mindfullness base therapy
cardiac rehab phase I protocols: ankel pumps, limbs ROMs, bed mobility. Do 5-10 minutes daily of breath awareness practice on your own. Plus Mindfullness base therapy

Locations

Country Name City State
Pakistan Punjab institute of cardiology hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (22)

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Outcome

Type Measure Description Time frame Safety issue
Primary Illness perception questionnaire 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. 4 months
Primary PHQ9 for depression assessment 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 4 months
Secondary HRQOL for quality of life Contemporary interpretations of HRQOL are based on the World Health Organization's definition of health as a state of complete physical, mental, and social well-being and not merely the absence of disease. contemporary HRQOL instrument domains are scored with a range of 0-100, with higher values representing better outcomes.
To make useful inferences regarding absolute scores or change scores over time
4 months
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