Borang REC 1 / 2012

Research Management Institute

Universiti Teknologi MARA
40450 SHAH ALAM
Tel: 03 5544-2094, Faks: 03 5544-2096/2767
Borang Permohonan Kelulusan Etika Application Form for Ethics Approval
Jawatankuasa Etika Penyelidikan Research Ethics Committee
Permohonan ini dikemukakan untuk tujuan kelulusan isu-isu Etika sahaja. Sila
lampirkan salinan kertas cadangan penyelidikan.
This application is for the purpose of obtaining approval for ethical issues only.Please attach a
copy of Research Proposal

BAHAGIAN A: Maklumat Ringkas Projek Part A : Brief Details of Project

Tajuk Projek :
Title of Project :

Quality of life among lower limb amputees in Malaysia

Nama Ketua Projek:

Name of Project Leader :

Muhammad Mahdi Bin Abdul Razak

No.Staf/No.Pelajar:
Staff ID/Student ID:

2011280154

Bidang Pengkhususan :
Area of Specialisation :

Student at Faculty of Medicine

Alamat Jabatan dan

Hospital/ Institut:

UiTM Sg Buloh

Affiliation :

No.Telefon/ E-mail :

013-3198251

Contact No/ E-mail :

Kelulusan Peringkat Fakulti Approval at Facultys Level

Ulasan Comments

Tandatangan Signature

Cop rasmi

Tarikh

Official stamp

Date

Pengerusi AJK Penyelidikan

Fakulti
Chairman of Faculty Research
Committee

Borang REC 1 / 2012

BAHAGIAN B: Protokol Projek Part B : Project Protocol

1.

Latar Belakang: Background

(Keterangan ringkas tentang masalah yang dikaji dan penyemakan literatur
untuk menyokong keterangan tentang masalah yang dikaji. Sila lampirkan
sekiranya ruang tidak mencukupi)
A brief explanation of the problem to be studied and literature review to support. Please
append if more space is required.

Lower extremity amputation is performed to remove ischemic, infected, necrotic

tissue or locally unresectable tumor, and at times, is a life-saving procedure.
Peripheral artery disease contributes for 79% of all amputations whereas trauma
is the second leading cause(1). Amputation causes a threefold loss in terms of
function, sensation and body image (2). It is often be associated with anxiety,
isolation, and depression(3) which may change the social and free-time activities
of the person with lower-limb amputation. Irrespective of the cause of
amputation, it brings a significant and drastic change in a persons life. This
dramatic change has an effect on the quality of life (QoL) of the individual due to
the physical activity limitations immediately after amputation as well as has
longer-term implications in varied facets of life(4). This background, and an
apparent dearth of publications on the combined participants of physical activity
and quality of life, led to the initiation of this study. Our results might be useful
to improve the quality of life and physical activity of lower limb amputee
patients in Malaysia.
Rujukan: Reference
(1) Lperi, T, et al., Lower-limb amputations. (1993, 82(3):183-187)
(2) Breakey, James W., Body Image: The Lower-Limb Amputee. (1997,9(2):58-66)
(3) Shula GD, Sahu SC, Tripathi RP, et al. A psychiatric study of amputees. Br J
Psychiatry. (1982;141:503)
(4) Horgan O, &MachLachlan M. Disabil Rehabil. (2004,26,837-850)

2.

Objektif dan Justifikasi Projek Penyelidikan Dijalankan:

Objectives and Justifications for the Project to be carried out :

To determine the factors associated with quality of life among lower limb
amputees in Malaysia.

Borang REC 1 / 2012

3.

Faedah yang Dijangka:

Expected Benefits :

-To improve the quality of life among lower limb amputees in Malaysia
-To identify the factors that affect poor quality of life among lower limb
amputees in Malaysia

4.

Jangkamasa Projek:
Timeframe of the Project :

From 9th June 2014 to 22th August 2014

5.

Lokasi Projek Penyelidikan dijalankan:

Location where the Project will be carried out :

1. Sg. Buloh Hospital

2. Selayang Hospital
3. Clinical Teaching Centre, Faculty of Medicine Sg. Buloh,
4.Bandar Utama Buddhist Society (BUBS) NGO in collaboration with the
Prosthesis Foundation of the HRH Princess Mother of Chiang Mai

6.

Keterangan bagaimana hasil kajian akan digunakan:

Explain how the results will be used :

-publication in indexed journal

-to be used as guidelines for further patient management and research.
7.

Kaedah Penyelidikan: (Sila terangkan perkara-perkara berikut)

Experimental : (Please explain the following)

A cross sectional study will be conducted with a group of lower limb amputees in
the elective centres by using a validated and standardised questionnaire. The
participants that we will chosen are from adult men and women who had
unilateral trans-tibial or trans-femoral lower limb amputation. The lower age
limit is 18 years. There is no upper age limit. Suitable participants will be given
the validated questionnaire through convenient sampling.

Borang REC 1 / 2012

7.1

Rekabentuk kajian, metodologi yang diguna:

Experimental design and methodology :

In order to measure the quality of life, the World Health Organization Quality-ofLife Scale (WHOQOL-Bref) self-administration questionnaire will be use. There
are 2 validated versions WHOQOL-Bref, one in Malay and the other is in
English. The World Health Organization (WHO) defines quality of life as an
individuals perception of their position in life in the context of the culture and
value systems in which they live and in relation to their goals, expectations,
standards, and concerns. The primary importance of this questionnaire is to
discover the individuals perceptions. Perception is a broad-ranging concept
affected in complex ways by the persons physical health, psychological state,
personal beliefs, social relationships, and relationships to salient features of their
environment.
7.2

Saiz sampel, kriteria pemilihan:

Sample size and selection criteria :

Our target sample size is 50.

Inclusion criteria;
-Participants give consent and agree to answer the questionnaires.
-Adult patients who had lost their limb due to trauma or non trauma will be
selected.
-Participants must be able to read and comprehend in Malay or English.
-The lower age limit is 18 years. There is no upper age limit.
Exclusion criteria; Participants with bilateral amputations.

7.3

Pembahagian kumpulan ujian dan kontrol; dan ciri-ciri kohort atau sampel
dan jenis kontrol:
Division of test and control groups, cohort properties or samples, and type of control :

Nil
7.4

Pemprosesan data dan penganalisaan statistik:

Data processing and statistical analysis :

All data will be analyzed using SPSS Version 20.

[Sila lampirkan contoh lembaran maklumat subjek dan borang persetujuan subjek]
Please attach examples of Subject Information Sheet and Subject Consent Form

Borang REC 1 / 2012

Bahagian C: Peruntukan Part C : Research grant

Geran projek:

Ada/ Tiada

Project Grant :

Already obtained/ Not obtained yet

Jika ada, nyatakan yang berikut:

If obtained, please state :

Jumlah peruntukan
Total allocation :

Jangkamasa peruntukan :
Duration of grant :

Borang REC 1 / 2012

Bahagian D: Pengesahan persetujuan menjalankan projek penyelidikan

Part D : Agreement to conduct the research project

Mesti dipenuhi dan ditandatangani oleh semua ahli kumpulan penyelidikan

Must be completed and signed by all members of the research group

1. Ketua Projek Project Leader

Nama:

Muhammad Mahdi Bin Abdul Razak

Name
No.Staf/No.Pelajar
Staff ID/Student ID

2011280154

Jawatan/ kepakaran:

Student at Faculty of Medicine

Position/ Specialisation

Jabatan

UiTM Sg Buloh

Affiliation

No. Tel

(o)

Tandatangan:

Handphone:0133198251
Email:
salammahdi01@gmail.com
Tarikh Date

Signature

2. Penyelidik bersama Co-researcher

Nama:

Muhammad Zubaidi Bin Tauhid

Name
No.Staf/No.Pelajar
Staff ID/Student ID

2011616788

Jawatan/ kepakaran:

Student at Faculty of Medicine

Position/ Specialisation

Jabatan

UiTM Sg Buloh

Affiliation

No. Tel
Tandatangan:

(o)

Handphone:0182239822
Email:
eddy_mzt@yahoo.com
Tarikh Date

Signature

Borang REC 1 / 2012

3. Penyelidik bersama Co-researcher

Nama:

Nursyamimi Mat Noh

Name
No.Staf/No.Pelajar
Staff ID/Student ID

2011430394

Jawatan/ kepakaran:

Student at Faculty of Medicine

Position/
Specialisation

Jabatan

UiTM Sg Buloh

Affiliation

No. Tel

(o)

Tandatangan:

Handphone: 0133909812
Email:
nursyamimimatnoh@yahoo.com
Tarikh Date

Signature

4. Penyelidik bersama Co-researcher

Nama:

Nurul Nabila binti Baharudin

Name
No.Staf/No.Pelajar
Staff ID/Student ID

2010636774

Jawatan/ kepakaran:

Student at Faculty of Medicine

Position/ Specialisation

Jabatan

UiTM Sg Buloh

Affiliation

No. Tel

(o)

Tandatangan:

Handphone:013-6704771
Email:
bungamedic@yahoo.com
Tarikh Date

Signature

5.

Penyelidik bersama Co-researcher

Nama:

Nurul Aqila Binti Ramlee

Name
No.Staf/No.Pelajar
Staff ID/Student ID

2011411586

Jawatan/ kepakaran:

Student at Faculty of Medicine

Position/ Specialisation

Jabatan

UiTM Sg Buloh

Affiliation

No. Tel
Tandatangan:

(o)

Handphone:0148438443
Email:
virgocell92@yahoo.com.my
Tarikh Date

Signature

Borang REC 1 / 2012

Penyelia Supervisor

Nama:
Name
No.Staf/No.Pelajar
Staff ID/Student ID

Nor Faissal bin Yasin

192976

Jawatan/ kepakaran:
Position/ Specialisation

Senior Lecturer

Jabatan
Affiliation

No. Tel

Orthopaedic Surgery, Faculty of Medicine

(o) 03-61267025

Tandatangan:

Handphone: 0172124122
Email:
drfaissal76@gmail.com
Tarikh Date

Signature

Penyelia bersama Co-supervisor

Nama:
Name
No.Staf/No.Pelajar
Staff ID/Student ID

Dr. Fazah Akhtar Hanapiah

279637

Jawatan/ kepakaran:
Position/ Specialisation

Senior Lecturer

Jabatan
Affiliation

Rehabilitation medicine, Faculty of Medicine

No. Tel

(o) 03-61267025

Tandatangan:

Handphone:0132152468
Email:
Tarikh Date

Signature