The effect of sleep health education on sleep quality in people with cancer during chemotherapy courses in Isfahan
Design
Clinical trials with control group, with parallel groups,randomized
Settings and conduct
The study was conducted in 1397_1398 in Isfahan.The target population of Cancer patients undergoing chemotherapy, referred to the Milad hospital and Alzahra clinic.
Participants/Inclusion and exclusion criteria
Willingness to participate in research
Having at least 18 and up to 65 years of age
Reading and writing skills
getting Cancer and being on chemotherapy course, For whatever reason,They were reluctant to continue in the study
If there is an unforeseen crisis or accident during the course of research for them
Failure to attend at least one training session
Questionnaires with at least 20% not completed are removed and replaced with other patients
Intervention groups
70 of these patients were selected by simple randomization method and then using SPSS software, 35 patients were randomly divided into two groups of intervention and 35 patients in control group. Sleep quality in both groups was assessed using the Pittsburgh Sleep Quality Index (PSQI).The researcher applied sleep education to the intervention group, after one and three weeks the quality of sleep was again assessed in both groups, and the results of the patients' sleep quality were compared before, one week and three weeks after the intervention.Intervention is conducted in 2 training sessions for 60 minutes using a lecture, group discussion, question and answer and educational pamphlets by a psychologist and a physician.
Main outcome variables
Sleep education, chemotherapy, sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190730044379N1
Registration date:2019-09-10, 1398/06/19
Registration timing:registered_while_recruiting
Last update:2019-09-10, 1398/06/19
Update count:0
Registration date
2019-09-10, 1398/06/19
Registrant information
Name
Ali Hajigholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6654
Email address
alihajigholami@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sleep education on the quality of sleep in cancer patients during chemotherapy
Public title
The effect of sleep education on the quality of sleep in cancer patients during chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research
Having at least 18 and up to 65 years of age
Reading and writing skills
getting Cancer and being on chemotherapy courses
Exclusion criteria:
For whatever reason,They were reluctant to continue in the study
If there is an unforeseen crisis or accident during the course of research for them
Failure to attend at least one training session
Questionnaires with at least 20% not completed are removed and replaced with other patients
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2019-08-04, 1398/05/13
Ethics committee reference number
IR.MUI.MED.REC.1398.242
Health conditions studied
1
Description of health condition studied
cancer patients during chemotherapy
ICD-10 code
Z51.11
ICD-10 code description
Encounter for antineoplastic chemotherapy
Primary outcomes
1
Description
Sleep education
Timepoint
Beginning of study and 8 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
Percentage of people with a Pittsburgh questionnaire score above 1
Timepoint
Beginning of study
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The two 60 minute training sessions are conducted by a psychologist and a physician using lecture style, group discussion, question and answer and educational pamphlets.
Category
Rehabilitation
2
Description
Control group: There is no cure for this group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra clinic
Full name of responsible person
Dr.Ali Hajigholami
Street address
Sheikh Mofid street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8164969479
Phone
+98 31 3663 1677
Email
ali_hajigholami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Shaghayegh haghjoo javanmard
Street address
Medical school of Isfahan, deputy of research
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8092
Fax
+98 31 3669 2174
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Ali Hajigholami
Position
Associated proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Medical university,Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0098 31 366855555
Fax
+98 31 3624 4221
Email
ali_hajigholami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Ali Hajigholami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
alzahra hospital,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0098 31 366855555
Email
Ali_hajigholami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Ali Hajigholami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Alzahra hospita,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0098 31 366855555
Email
ali_hajigholami@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be accessible
When the data will become available and for how long
Immediately after the article was published
To whom data/document is available
To anyone who needs this information
Under which criteria data/document could be used
Email to Dr Haji gholami
Email:Ali_hajigholami@yahoo.com
From where data/document is obtainable
Dr Ali Hajigholami
Email:ali_hajigholami@yahoo.com
What processes are involved for a request to access data/document