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The effect of a psycho-educational program on the sleep quality of patients with Leukemia

Protocol summary

Study aim
Determining the effect of a psycho-educational program on the sleep quality of patients with Leukemia
Design
The study groups included patients with different types of leukemia who are referred to the selected hospital of Isfahan University of Medical Sciences and have entry requirements. After convenient Sampling, samples as non random allocation are divided into two groups based on the even file number (intervention group) and odd file number (control group). The sample size is estimated to be 30 in each group. Clinical trial with a control group, with parallel groups, non randomized trial.
Settings and conduct
Place: Seyed al Shohada Hospital in Isfahan How to do: At first, the questionnaires are completed before the intervention. Then, the training sessions are held for both groups. After a month, the sleep quality questionnaire is completed again.
Participants/Inclusion and exclusion criteria
Entry requirements: age more than 18 years, definite leukemia diagnosis, ability to read and write, ability to attend training sessions, sign a written informed consent, least 6 months past to diagnose the disease, knowing the patient of illness. Conditions of no entry: other chronic diseases, end-stages of life, use of psychiatric drugs, admission to psychiatric wards
Intervention groups
Intervention group: 6 sessions. sessions topics: 1. definition of disease, 2. sleep disorders and hypnotic drugs, 3. stress and relaxation techniques, 4. pain control, 5. review of previous contents, 6. question and answer, and filling the questionnaire. Control group: a cancer education training session in the form of a pamphlet.
Main outcome variables
Quality of sleep in patients with leukemia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181006041249N1
Registration date: 2018-12-18, 1397/09/27
Registration timing: registered_while_recruiting

Last update: 2018-12-18, 1397/09/27
Update count: 0
Registration date
2018-12-18, 1397/09/27
Registrant information
Name
faeze Ashenaye roudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5422 2075
Email address
faeze.ashena@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a psycho-educational program on the sleep quality of patients with Leukemia
Public title
The effect of a psycho-educational program on Leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have more than 18 years of age; Diagnosis of leukemia is confirmed by an expert oncologist; Ability to communicate and have the physical and mental ability to attend training sessions and complete the questionnaire; Written informed consent to participate in the study; At least 6 months past from diagnosis; Patient aware of his or her illness; Ability to read and write.
Exclusion criteria:
Have other chronic diseases; The patient is in the final stages of life; Use of psychiatric drugs; Hospitalization in psychiatric departments.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
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
Hezar jerib street، Dormitory of isfahan university
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-01-08, 1396/10/18
Ethics committee reference number
IR.MUI.REC.1396.3.698

Health conditions studied

1

Description of health condition studied
Leukemia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sleep quality
Timepoint
At the beginning of the study, before the intervention and one month after the intervention
Method of measurement
Petersburg Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention consists of 5 one-hour sessions, once a week, and one 1-hour session, which is held one month later. Sessions are held individually or in groups of 12 to 8 people, depending on the sample participation. Contents are provided by PowerPoint and by the researcher. Training topics: 1. Definition of the disease 2. Sleep disturbances and hypnotic drugs 3. Stress and relaxation techniques 4. Pain control 5. Review of the contents of the previous sessions 6. Questions and Answers , Complete questionnaires.
Category
N/A

2

Description
Control group: Only receive a general cancer education session.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyed Alshohada hospital in Isfahan
Full name of responsible person
Faeze Ashenaye Roudi
Street address
Motahari Street
City
Isfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3236 8005
Email
faeze.ashena@nm.mui.ac.ir
Web page address
http://omid.mui.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoye Javanmard
Street address
Hezar jerib Street، Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱ -۸۱۷۴۶
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
http://research.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
Masoud Bahrami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar jerib Street، Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7563
Email
bahrami@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Bahrami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar jerib Street، Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7563
Email
bahrami@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faeze Ashenaye Roudi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hezar jerib، Dormitory of Isfahan University
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 51 5422 2075
Fax
Email
faeze.ashena@nm.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be published after being unidentifiable through the article
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only scholars working in academic institutions
Under which criteria data/document could be used
No other use is allowed
From where data/document is obtainable
Email to: faeze.ashena@nm.mui.ac.ir.
What processes are involved for a request to access data/document
The request will be sent to the registered email address sent after the data email is read.
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