]>
IRCT20150630022991N16 IRCT 2023-08-21 Babol University of Medical Sciences The effect of sleep hygiene education on patients with breast cancer Evaluation of effectiveness of sleep hygiene education on sleep quality of patients with breast cancer 2023-07-23 anticipated 74 Complete https://irct.ir/trial/71448 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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, 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. 3 Sleep disorder. Intervention 1: 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. Intervention 2: Control group: Free psychiatric visit for one month. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the limitations associated with the database of breast cancer patients, there is no plan to publish the data of these patients.
public Sussan Moudi
Babol University of Medical Sciences, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 4717641367 +98 11 3236 8823 sussan.mouodi@gmail.com Babol University of Medical Sciences scientific Sussan Moudi
Babol University of Medical Sciences, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 4717641367 +98 11 3236 8823 sussan.mouodi@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 to 65 years Breast cancer in stage 3 who have undergone mastectomy Self-reported sleep disorder 18 years 65 years Female Severe psychiatric disorders, dementia or delirium in patient Illiteracy Consumption of sedative drugs before participation in the study F51 Sleep disorders not due to a substance or known physiological condition Lifestyle Lifestyle 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. Control group: Free psychiatric visit for one month 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. Babol University of Medical Sciences Approved 2022-02-02 Ethics Committee of Babol University of Medical Sciences Ganjafrooz Avenue, Babol Babol Mazandaran Iran (Islamic Republic of)