Assessment of Quality of Life in Thalassemic Patients at Assiut University Hospital: A Single-center Experience

March 17, 2023 updated by: Reham Abdelraheem, Assiut University

The thalassemias are a group of inherited hematologic disorders caused by defects in the synthesis of one or more of the hemoglobin chains [1]. Thalassemia are classified into the alpha (α) and (β) thalassemia, which contain deficits in (α) and (β) globin production respectively (α)thalassemia are caused by decreased production of alpha-globin chains from chromosome 16. There are 4 types of (α) thalassemia: thalassemia silent carrier thalassemia carrier . Hemoglobin H disease thalassemia major Beta-thalassemia are caused by point mutations or more rarely deletions in the β-globin gene on chromosome 11, leading to reduced (β+) or absent (β0) synthesis of the β chains of hemoglobin. Imbalances of globin chains cause hemolysis and impair erythropoiesis [4-7]. β-thalassemia can be classified into: Beta Thalassemia major, Beta Thalassemia intermedia, Beta Thalassemia minor Thalassemia is a chronic disease that presents a range of serious clinical and psychological challenges.

The effects of thalassemia on physical health can lead to physical deformity, growth retardation, and delayed puberty [9, 10]. Its impact on physical appearance, e.g., bone deformities and short stature, also contributes to a poor self-image [10, 11]. Severe complications such as heart failure, cardiac arrhythmia, liver disease, endocrine complications, and infections are common among thalassemia patients [8, 12].

Study Overview

Status

Not yet recruiting

Conditions

Thalassemia

Intervention / Treatment

Device: Abdominal ultrasound

Detailed Description

The problems mentioned do not only affect patients' physical functioning but also their emotional functioning, social functioning and school functioning, leading to impaired Health-related quality of life (HRQOL) of the patients [13]. QOL is a phrase used to refer to an individual's total wellbeing. This includes all emotional, social, and physical aspects of the individual's life. Health-related quality of life (HRQOL) Moreover, the term health-related quality of life (HRQOL) is often described as: "A term referring to the health aspects of quality of life, generally considered to reflect the impact of disease and treatment on disability and daily functioning; it has also been considered to reflect the impact of perceived health on an individual's ability to live a fulfilling life.[18-19] HRQOL is comprised of a number of dimensions of influence. Seven are commonly agreed upon

Physical well-being: the experience of physical symptoms such as pain, dyspnea, or nausea.
Functional well-being: the ability to participate in normal daily activities such as work and leisure pursuits.
Emotional well-being: this is comprised of both positive affective states (e.g. happiness, peace of mind) and negative affective states (e.g. sadness, anxiety).
Family well-being: the ability to maintain family relationships and communication.
Social functioning: the ability to participate and enjoy social roles and activities.[20]
Treatment satisfaction: including financial concerns.
Sexuality/intimacy: including concerns about body image.

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Reham Abdelraheem
Phone Number: 01005558459
Email: rehamabdelraheem128@gmail.com

Study Contact Backup

Name: Ahmad Farrag
Phone Number: 01061461306
Email: Drahmedfarag2005@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Thalassemic patients more than 18 years old.

Description

Inclusion Criteria:

Thalassemic patients more than 18 years old.

Exclusion Criteria:

Thalassemic patients less than 18 years old. Patients with other causes of aneamia. Patients with other causes of liver cirrhosis. Patients with other causes of renal diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assisment of Quality of life in thalassemic patient Time Frame: baseline	assess the health-related quality of life among thalassemic patients attending Clinical hematology unit, Assiut University Hospital in a questionnaire manner	baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)