Evaluation of effectiveness of sleep hygiene education on sleep quality of patients with breast cancer
Design
A clinical trial, randomized, non-blinded, with a control group, with a parallel design, for 74 patients who are randomly allocated in two intervention and control groups and will be followed for 30 days.
Settings and conduct
This study will be conducted in two referral hospitals of Babol University of Medical Sciences on patients with breast cancer who have undergone mastectomy and have self-reported impaired sleep quality. Patients are followed for one month. Randomization is performed using permutation blocks method and with blocks of size 4. In each block, an equal number of people are allocated to both groups. The order of placement of intervention and control groups in each block is determined by a statistician.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age18 to 65 years; Suffering from stage 3 breast cancer who have undergone mastectomy.
Exclusion criteria: Patients with serious psychiatric disorders, dementia or delirium; Illiteracy; Taking sedative drugs before entering the study.
Intervention groups
Intervention group: Virtual and face-to-face training on the principles of sleep hygiene and free psychiatric visits for one month.
Control group: Free psychiatric visit for one month.
Main outcome variables
Sleep quality based on Pittsburgh Sleep Quality Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150630022991N16
Registration date:2023-08-21, 1402/05/30
Registration timing:registered_while_recruiting
Last update:2023-08-21, 1402/05/30
Update count:0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of sleep hygiene education on sleep quality of patients with breast cancer
Public title
The effect of sleep hygiene education on patients with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Breast cancer in stage 3 who have undergone mastectomy
Self-reported sleep disorder
Exclusion criteria:
Severe psychiatric disorders, dementia or delirium in patient
Illiteracy
Consumption of sedative drugs before participation in the study
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is conducted using permutation blocks method and with blocks of size 4. In each block, an equal number of people are assigned to both groups (intervention and control). The order of placement of intervention and control groups in each block is determined by a statistician.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In order to conceal the treatment process, envelopes with the same shape are prepared according to the number of participants. A three-digit code is written on each envelope. Whenever the intervention initiates, an envelope is opened for each participant with the order of which has been already specified. Type of treatment (intervention or control) has been written inside the envelope.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4136747176
Approval date
2022-02-02, 1400/11/13
Ethics committee reference number
IR.MUBABOL.REC.1400.266
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
Sleep quality
Timepoint
At the beginning of the study (day zero) and one month after the intervention
Method of measurement
Using the Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Virtual and face-to-face education of sleep hygiene and free psychiatric visit for one month. Following points are taught to the patient: 1- To sleep at a certain time and wake up at a certain time every day. 2- If she is hungry, she should eat a light meal before going to bed. 3- Have a regular exercise program. 4- Have almost an hour of relaxation before going to bed. 5- Keep her bedroom cool. 6- The bedroom should be dark. 7- The bedroom should be quiet. 8- Do not exercise right before going to bed. 9- Do not eat in bed. 10- A specific place should be considered to sleep and it should only be used for sleeping. 11- If she is worried about something while sleeping, she should write it down and deal with it tomorrow morning. 12- People who have insomnia, it is better to avoid daytime sleep. 13- Don't keep looking at the clock when she has insomnia. 14- Reducing the use of devices with screens before going to bed. 15- Do not eat heavy meals before going to bed. 16- Do not use tea and coffee after 6 o'clock in the evening. 17- Don't smoke if she can't sleep. 18- Do not use alcohol to help sleep. 19- Do not exercise in bed. 20- Don't talk on the phone in bed.
Category
Lifestyle
2
Description
Control group: Free psychiatric visit for one month
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
The surgery department of Shahid Beheshti Hospital
Full name of responsible person
Novin Nikbakhsh
Street address
Shahid Ghassemi Street
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 911 122 7003
Fax
+98 11 3225 1664
Email
novinsu@hotmail.com
Web page address
https://beheshti.mubabol.ac.ir/
2
Recruitment center
Name of recruitment center
The surgery department of Ayatollah Rohani Hospital
Full name of responsible person
Novin Nikbakhsh
Street address
Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8300
Fax
+98 11 3223 8309
Email
novinsu@hotmail.com
Web page address
https://rohani.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
ramazan69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3236 8823
Email
sussan.mouodi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3236 8823
Email
sussan.mouodi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3236 8823
Email
sussan.mouodi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the limitations associated with the database of breast cancer patients, there is no plan to publish the data of these patients.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no program for sharing the research data.
When the data will become available and for how long
There is no program for sharing the research data.
To whom data/document is available
There is no program for sharing the research data.
Under which criteria data/document could be used
There is no program for sharing the research data.
From where data/document is obtainable
There is no program for sharing the research data.
What processes are involved for a request to access data/document
There is no program for sharing the research data.