This study is a randomized trial single blind, with two groups. The aim of study is Comparison the effects of using multimedia and pamphlet on anxiety, side effects and self-care behaviors of patients undergoing radiotherapy. The study population included patients with head and neck radiotherapy. Main Inclusion criteria include having no chemotherapy in last three months, radiotherapy for the first time, ability to read and write in patient or main caregivers, having acceptable visual and hearing ability for receiving education. The main Exclusion criteria include Unwillingness to continue cooperation, unstable situation in patient that making impossible to continue participate, receiving information from the other sources apart from intervention during the program and do not use of provided educational content until the first session of treatment. The total sample size is 33 patients per group, so 66 patients in both group were considered. In both group one individual educational session will be held on a day in which patient visits and the physician diagnoses the need of radiotherapy for him. One group will receive the provided pamphlets and the other group will receive multimedia.The patients will be asked to use educational contents at least one time before the first session of treatment. Pamphlets and multimedia educational content will be the same in both groups and they have information about how radiotherapy is don, possible side effect and recommendation for managing the side effects. Outcomes of this study are self-care behaviors, anxiety and side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010520559N1
Registration date:2015-06-03, 1394/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-03, 1394/03/13
Registrant information
Name
Atefeh Behboodifar
Name of organization / entity
Mashhad University Of Medical Science- Nursing And Midwifery University
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
behboudifara1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical science
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of using multimedia and pamphlet on anxiety, side effects and self care behaviors of patients undergoing radiotherapy
Public title
Education of self care behaviors in patients undergoing radiotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:1-Age between 18 and 65 2-Patient that Singed Consent Knowingly 3-Decisive diagnose for needing radiotherapy by physician 4-Have no chemotherapy in last three months
5-Radiotherapy for the first time 6-Head and neck radiotherapy 7-Patient or close family not to be in health group 8-Ability to read and write in patient or main caregivers 9-Enough ability for receiving education 10-Having acceptable visual and hearing ability for receiving education
Exclusion criteria: 1- Unwillingness to continue cooperation 2-Stressful events during intervention such as divorce, death in close family and losing job 3-Unstable situation in patient that making impossible to continue participate 4-Receiving information from the other sources apart from intervention during the program(for example participate in other education program or classes) 5-Do not use of provided educational content until the first session of treatment.
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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 Mashhad University Of Medical Science
Street address
Ghoraishy Building, University"St". Mashhad
City
Mshhad
Postal code
9177899191
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
930947/1/407
Health conditions studied
1
Description of health condition studied
head and neck cancers
ICD-10 code
c00-c14
ICD-10 code description
Malignant neoplasms of lip, oral cavity and pharynx
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention and almost 2 weeks after intervention depending on the time of starting treatment
Method of measurement
Spielberger STAI
2
Description
Radiotherapy Side Effects
Timepoint
First, third and fifth week after intervention
Method of measurement
Nail's Self Care Diary
3
Description
Self-care behaviors
Timepoint
First, third and fifth week after intervention
Method of measurement
Nail's Self Care Diary
Secondary outcomes
1
Description
Severity of side effects of radiotherapy
Timepoint
First, third and fifth week after interventin
Method of measurement
Nail's Self Care Dairy
Intervention groups
1
Description
After a one individual session for the 20 minutes about radiotherapy, local and systematic side effects, the 20 minutes Multimedia will be delivered to the patients or transfer to their mobiles as they want. The patients will be asked to use it before the first session of treatment. This file contents several parts. The first part contents general information about disease and treatments. The second part contents information about radiotherapy and treatment environment. The third part contents information about possible side effects (sleep disorders, loss of appetite, fatigue and mouth dryness), management of these side effects and necessary cares for them. Final part contents an exam with 5 questions about delivered subjects that after specified time for answering ,the responses will be displayed. Most of the designed file containing sounds and images and in some parts texts is used.
Category
Other
2
Description
In pamphlet group after individual training session, three pamphlets that have same content with multimedia include general information about radiotherapy and treatment environment, possible side effects (such as sleep disorders, loss of appetite, fatigue and mouth dryness), management of these side effects and necessary cares for them will be delivered to the patients and asked them to read the pamphlets before the first session of treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Fatemeh Kavousi
Street address
Alandasht"Sq". Kuhsangi "St". Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mojhgan Ghiyassi
Street address
Ebne sina "Ave". Mashhad
City
Mashhad
3
Recruitment center
Name of recruitment center
Reza center of radiotherapy
Full name of responsible person
Dr. Mozafari
Street address
Fallahi 2, Ghasem abad "Blvd". Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University Of Medical Science
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoraishy Building, University"St". Mashhad
City
Mashhad
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, Mashhad University Of Medical Science
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
Mashhad University Of Medical Sciences
Full name of responsible person
Atefeh Behboodifar
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Number82, Modaress 11"St". Vakil abad "Blvd". Mashhad