The main objective of the study is to determine the effect of education using cell phone software on nausea, vomiting and anxiety in patients undergoing chemotherapy.
Patients will be allocated into two intervention and control group through block randomization method. Each group will include 25 people.
Inclusion criteria: the patient has received at least one course of chemotherapy; Patients have cisplatin or cyclophosphamide in the chemotherapy drug list; having a smart phone with the capability of software installation. Exclusion criteria: using other methods like alternative medicine or herbal remedy to control nausea, vomiting and anxiety; Any other condition that leads to nausea and vomiting in patients such as intestinal obstruction.
Interventions: Intervention group: educational content will be provided to the patients through an educational cellphone software in addition to routine hospital ward education during one month.
Control group: patients will receive routine hospital ward education during one month.
The primary outcome variables include nausea, vomiting and anxiety.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016100430128N1
Registration date:2017-05-05, 1396/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-05, 1396/02/15
Registrant information
Name
Seyedeh Zeynab Alboghobeysh
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 613332368
Email address
alboghobeysh.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research, Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mobile-based Education on nausea, vomiting and anxiety in patients undergoing chemotherapy
Public title
The impact of mobile-based education on side effects of chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the patients have received at least one course of chemotherapy; Patients have cisplatin or cyclophosphamide in the chemotherapy drug list; having a smart phone with the capability of software installation. Exclusion criteria: using other methods like alternative medicine or herbal remedy to control nausea, vomiting and anxiety; any other condition that leads to nausea and vomiting in patients such as intestinal obstruction.
Age
From 20 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation has been done through block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Ahvaz University Of Medical Sciences
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan Blvd., University City, Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2016-07-09, 1395/04/19
Ethics committee reference number
IR.AJUMS.REC.1395.218
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
C80.9
ICD-10 code description
Malignant neoplasm, unspecified
Primary outcomes
1
Description
Vomiting
Timepoint
Before and one month after intervention
Method of measurement
East oncology scale
2
Description
Nausea
Timepoint
Before and one month after intervention
Method of measurement
Visul analogue scale (VAS)
3
Description
Anxiety
Timepoint
Before and one month after intervention
Method of measurement
state-trait anxiety inventory
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: cellphone-based training. Teaching methods: providing patients with an educational cellphone software. Intervention period: a month
Category
Other
2
Description
Control group: providing patients with routin hospital ward education. Intervention period: a month
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Seyedeh Zeynab Alboghobeysh
Street address
Shafa Hospital, Ahvaz Jundishapour University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Of Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Bhzad Sharif Makhmalzadeh
Street address
Ground floor, Vice Chancellor for Research and Technological Development Ahvaz Jundishapour University of Medical Sciences, University City, Ahvaz, Khuzestan
City
ahvaz
Grant name
-
Grant code / Reference number
- -
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research Of Ahvaz Jundishapour 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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Seyedeh Zeynab Alboghobeysh
Position
Masters student
Other areas of specialty/work
Street address
Ahvaz Jundishapour University of Medical Sciences، Golestan Blvd.، University City، Ahvaz،Khuzestan
City
Ahvaz
Postal code
61357-15794
Phone
+98 613332368
Fax
+98 33 61544
Email
Alboghobeysh.z@ajums.ac.ir
Web page address
http://www.ajums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Marziyeh Asadizaker
Position
Senior student-Surgical Nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan Blvd., University City, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 613332368
Fax
+98 33 61544
Email
marziyehasadizaker@gmail.com
Web page address
http://www.ajums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Seyedeh Zeynab Alboghobeysh
Position
Master student
Other areas of specialty/work
Street address
Ahvaz Jundishapour University of Medical Sciences، Golestan Blvd.، University City، Ahvaz، Khuzestan
City
Ahvaz
Postal code
61357-15794
Phone
+98 613332368
Fax
+98 33 61544
Email
Alboghobeysh.z@ajums.ac.ir
Web page address
www.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)