The effect of oral care program and honey mouthwash on mucositis, weight loss and quality of life of patients with Acute Myeloid leukemia undergoing chemotherapy: A Randomaized Clinical Trial
This study aimed to determine the effect of oral care protocol, honey mouthwash and compare the effects of two types of intervention on prevention of mucositis, weight loss and quality of life of patients with acute myeloid leukemia under Chemotherapy at Ghazi Tabatabaie hospital in Tabriz .This study is a Single-blind randomized clinical trial for four weeks in the three groups (oral care, honey mouthwash and control) will be done. Finally, 51 patients (17 patients per group) of male and female patients that having Inclusion criteria; adults (over 18 years) with acute myeloid leukemia undergoing chemotherapy for the first time under chemotherapy (7 + 3 regimen) and exclusion criteria: thrombocytopenia and promyelocytic leukemia will be randomly selected. In oral care group, participants will use soft toothbrush twice a day, flossing once a day and normal saline oral rinse three times a day before and after every eating meal and before bed-time. Honey mouthwash group, a solution of a tablespoon of honey in a glass of mild water and gurgle three times a day, before and after each meal and before bed time. The control group will receive routine care. The main outcome of the study is mucositis. . For measuring Weight and mucositis outcomes, instruments will be completed once before and then at the end of each week and quality of life instrument will be completed once before and once at the end of four weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121419919N7
Registration date:2016-02-01, 1394/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Arefeh Davoodi Bavil Oliaii
Name of organization / entity
Nursing and Midwifery of Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0648
Email address
adavoodi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral care program and honey mouthwash on mucositis, weight loss and quality of life of patients with Acute Myeloid leukemia undergoing chemotherapy: A Randomaized Clinical Trial
Public title
The effect of oral care and honey mouthwash on the mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Adults (over 18 years) undergoing chemotherapy with AML is the first candidate for chemotherapy. Not using smoking, hookah, tobacco, opioid and alcohol, do not receive radiotherapy and treated with induction (3+7 regimen)
Exclusion criteria: discharged against medical advice or death during study, lack of patient cooperation, having thrombocytopenia (platelet count less than 20,000 per m m3), previous radiotherapy and chemotherapy in patients, promyelocytic leukemia AML m3 for treatment of arsenic (if the patient along with arsenic regimen 3+7 receive will be part of the intervention group)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
South Shariety St; Faculty of Nursing and Midwifery- Tabriz, East Azarbayjan Iran, Islamic Republic Of
City
Tabriz
Postal code
51745347
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
11458/4/5
Health conditions studied
1
Description of health condition studied
mucositis
ICD-10 code
K12.3
ICD-10 code description
(Oral mucositis (ulcerative
Primary outcomes
1
Description
mucositis
Timepoint
Once before and four after the intervention (at the end of the first week, second, third and fourth)
Method of measurement
WHO scale
Secondary outcomes
1
Description
Quality of life
Timepoint
Once before and once at the end of the fourth week after intervention
Method of measurement
EORTC QLQ – C30 . V .3 questionnaire
2
Description
weight
Timepoint
Once before and four after the intervention (at the end of the first week, second, third and fourth)
Method of measurement
Balance
Intervention groups
1
Description
In oral care intervention program involves the use of a soft toothbrush twice a day, flossing once, three times a day before and after every meal and before bed-time of normal saline (60 mL for 30 seconds ) will be used. Finally, a written training program will be given to the patient and his family
Water will be used to protect the lips
Category
Prevention
2
Description
The intervention group that receive honey mouthwash, a solution of a big tablespoon of honey that will be solved in mild water gurgled and keep in the mouth that can involve the entire surface of the mouth, gums and tongue.
this solution, will be three times a day, before and after eating meal and once before sleeping,for 30 seconds.
Category
Prevention
3
Description
In the control group patients only receive routine care and intervention will be done.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghazi tabatabaie hospital in the Tabriz
Full name of responsible person
Arezoo khanjani
Street address
Shariety South St ; Faculty of Nursing and Midwifery
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kazem Shakori
Street address
Deputy of Medical Sciences University of Tabriz,Tabriz, Est Azarbayjan
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Arezoo khanjani
Position
Nursing student of MS/ Nurse
Other areas of specialty/work
Street address
South Shariety St; Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3347 7379
Fax
Email
arezookhanjani68@ gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azad Rahmani
Position
Master of nursing
Other areas of specialty/work
Street address
South Shariety St; Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3347 7379
Fax
Email
azad.rahmani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azadeh Rahmani
Position
Master of nursing- Faculty member
Other areas of specialty/work
Street address
Shariety South St ; Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3347 7379
Fax
Email
azad.rahmani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)