BACKGROUND AND OBJECTIVES: Cupping has been used in the treatment of pain and many other complaints for millennia. The objective of the study will be to assess the effect of wet cupping (Hijama) on the Health-Related Quality of Life (HQOOL) of patients complaining from chronic medical conditions and referred to cupping clinic in King Abdulaziz University Hospital (KAUH), Jeddah, Saudi Arabia.
DESIGN AND SETTINGS: An intervention study with pre-test, intervention and post- tests will be done at the Cupping Clinic, KAUH will be done
METHODS: Patients’ HRQOL will be assessed before and after cupping using the World Health Organization Quality of Life assessment instrument (WHOQOL- BREF). Both descriptive and analytic statistics were done. Differences in the four domains of HRQOL were assessed before and after cupping.
General information
Acronym
Effect of cupping on QoL
IRCT registration information
IRCT registration number:IRCT2015050322060N1
Registration date:2015-05-16, 1394/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Nahla Ibrahim
Name of organization / entity
King Abdulaziz University
Country
Saudi Arabia
Phone
00966501632237
Email address
nibrahim@kau.edu.sa
Recruitment status
Recruitment complete
Funding source
Scientific Chair of Yousef Abdul Latif Jameel (YAJ)
Expected recruitment start date
2012-09-01, 1391/06/11
Expected recruitment end date
2015-06-01, 1394/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Wet cupping on Quality of Life of Adult Patients Complaining from Chronic Medical Conditions in King Abdulaziz University
Public title
Wet cupping improve Quality of Life of Adult Patients Complaining from Chronic Medical Conditions in King Abdulaziz University
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: include all adult patients (18-60 years) referred for chronic conditions, fully understand the research process and willing to provide informed consent.
Exclusion criteria:
Patients will be excluded from the study if they were using medication on regular basis, if they not willing to comply with the study protocol or if they had mental illnesses that interfere with completing the study.
Age
From 18 years old to 60 years old
Gender
Male
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
An intervention study with pre-test, intervention and post- tests were done at the Cupping Clinic, KAUH
Pre-test: Upon enrollment, all patients completed a validated, pre-constructed, self-administered, confidential questionnaire. The questionnaire will be used to collect personal and socio-demographic data as well as data about the reason for referral to the Cupping Clinic. They were requested to report the type of pain and other medical conditions. The HRQOL will be assessed using the WHOQOL- BREF before and after cupping. The WHOQOL-BREF contains 26 questions, two of which are general and 24 that assess four domains, namely physical health, psychological health, social relationships, and environmental domains. The internal consistency of the WHOQOL- BREF and the four domains of the questionnaire will be assessed and ranged from 0.66 – 0.925. The content validity, construct validity, and the reliability of the WHOQOL-BREF are good. 11,12
Intervention: Wet cupping will be performed by an expert certified physicians who regularly performed cupping in the clinical settings.
Post-test: Patients completed the same questionnaire one month after cupping. They were also asked about pain improvement after cupping, and if present when the felt the improved pain.
Outcome measures: Scoring of the various continuous HRQOL domains will be done according to the WHOQOL-BREF at the baseline and one month after cupping treatment.
Secondary Ids
1
Registry name
Registration in the IRB
Secondary trial Id
Reference Number: 851-12
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board (IRB) of the Faculty of Medicine, King Abdulaziz Universty Hospital. The
Street address
Faculty of Medicine, KAUH, and it was conformed to the ethical standards of the Helsinki Declaration.
City
Jeddah
Postal code
21551
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
Reference Number: 851-12.
Health conditions studied
1
Description of health condition studied
Chronic medical conditions
ICD-10 code
XIII
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue (M00-M99)
Primary outcomes
1
Description
Scoring of the various continuous Health related Quality of Life (HRQOL ) domains according to the WHOQOL-BREF at the baseline and one month after cupping treatment. R
Timepoint
After cupping, Post -test Scoring of the various continuous Health Related Quality of Life (HRQOL ) domains
Method of measurement
HRQOL WHO The WHOQOL-BREF contains 26 questions, two of which are general and 24 that assess four domains, namely physical health, psychological health, social relationships, and environmental domains.
Secondary outcomes
1
Description
Improve general condition, decrease pain
Timepoint
After the wet cupping
Method of measurement
Questionnaire
Intervention groups
1
Description
Cupping clinic was approved by the Faculty and the University.
A clinical trial study (Quasi-experimental study) with pre-test, the intervention by cupping, and post-test was done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
King Abdulaziz University Cupping clinic. It was approved by faculty and the university.
Full name of responsible person
Prof. Soad Al Jaouni
Street address
King Abdulaziz University, 1Hematology Department, Faculty of Medicine,
City
Jeddah
2
Recruitment center
Name of recruitment center
Yousef Abdul-Latif Jameel (YAJ) Cupping Clinic in King Abdulaziz Univerity Hospital
Full name of responsible person
Prof. Soad Al Jaouni
Street address
King Abdulaziz University, 1Hematology Department, Faculty of Medicine,
City
Jeddah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yousef Abdul-Latif Jameel Chair for Prophetic Medicine
Full name of responsible person
Prof. Soad Al Jaouni
Street address
King Abdulaziz University, 1Hematology Department, Faculty of Medicine,
City
Jeddah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yousef Abdul-Latif Jameel Chair for Prophetic Medicine
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yousef Abdul-Latif Jameel
Full name of responsible person
Prof. Soad Al Jaouni
Position
Professor of Hematology Department, Faculty of Medicine,
Other areas of specialty/work
Street address
King Abdulaziz University, Hematology Department, Faculty of Medicine,
City
Jeddah
Province
Jamaa
Postal code
21551
Phone
00
Fax
Email
dr.jaouni@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
King Abdulaziz University
Full name of responsible person
Prof. Nahla Ibrahim
Position
Prof. of Epidemiology MBBCh, MPH, Dr.PH (Epid), DHPE, JMHPE (Maastricht & SCU).