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IRCT20220528055007N1 IRCT 2022-08-31 Arak University of Medical Sciences Effect of education and virtual support on sleep in cancer Effect of Supportive Educational Intervention through virtual social networks on the sleep of cancer patients 2019-08-01 anticipated 66 Complete https://irct.ir/trial/64033 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Formulas for determining the sample size are a minimum criterion, and the number of samples in each group can be increased depending on the project feasibility without imposing more cost on the study. Thus, in this study, we decided to add seven samples in each group to the specified minimum number of samples, which is not a problem in terms of methodology. Sampling was performed when patients were referred to the hospital for chemotherapy. Then the samples were randomly divided into two groups of 40 with random allocation in the intervention (A) and control (B) groups. First, the Quadruple blocks were defined as follows: ABAB, BBAA, BABA, BAAB, AABB, ABBA, etc., and were placed in an envelope and numbered, and the blocks were determined using a table of random numbers, and the individuals in terms of A and B They were divided into intervention and control groups. Patient A was in the supportive educational intervention group through Soroush virtual social network and patient B was in the control group. N/A Condition 1: Insomnia. Condition 2: Sleepiness. Condition 3: Sleep quality. Intervention 1: Intervention group: Participants in the intervention group were contacted through a virtual social network allowing users to send and receive texts, photos, videos, and audio. The intervention group received supportive training messages on sleep in addition to routine care. The content of the messages was developed as a protocol based on the latest investigations and textbooks on cancer nursing and supportive care and was approved by the oncology department. The messages, including explanations about insomnia management, sleep quality, and strategies to improve sleep quality (sleep health, nutritional advice, place and time of sleep, relaxation techniques, and stress and anxiety management), were sent to the intervention group in two to three text messages with related pictures and audio and video files (8 am to 8 pm) every day for one month. The participants were asked to send the message "the message was read" to the researcher. If the message were not read for more than 24 hours, a reminder message would be sent. To ensure that educational content was understood, the participants were asked two to three questions at the end of each week to obtain feedback. The participants' questions were also answered. After finishing the intervention, the participants were asked to review the sent messages and report their sleep quality for one month. To support the participants, they were constantly monitored and encouraged to perform training. Intervention 2: Control group: The control group received routine care. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after unidentifiable individuals and also information about the main implications. When: Access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: Researchers working in academic institutions can submit requests for unidentified personal data or other documents. Where to obtain: To receive the data, send an email to the responsible author, Dr. Nazi Nejat. N.nejat@arakmu.ac.ir How to obtain: After receiving the email, the data will be sent within one working week. Comments:
public Elahe Sarlak
School of Nursing., Third Floor., Blue Wing., Arak University of Medical Sciences., Payambar Azam University Complex., Basij sq., Arak Town
Arak Iran (Islamic Republic of) 6861967991 +98 66 4333 5104 nazinejat@gmail.com Arak University of Medical Sciences scientific Elahe Sarlak
School of Nursing., Third Floor., Blue Wing., Arak University of Medical Sciences., Payambar Azam University Complex., Basij sq., Arak Town
Arak Iran (Islamic Republic of) 6861967991 +98 66 4333 5104 sarlakelahe41@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) The age range between 25-65 years Definitive diagnosis of GIC (esophagus, stomach, liver, pancreas, and colorectal) Chemotherapy treatment Cancer awareness Smartphone availability Reading and writing ability Absence of mental illnesses and underlying diseases causing sleep No drug addiction Getting a higher than average score in the Pittsburgh Sleep Quality Questionnaire and one of the two questionnaires of Insomnia Severity Index and Epworth Sleepiness Scale 25 years 65 years Both Unwillingness to participate in the study G47.0 G47.2 G47.2 Disorders of initiating and maintaining sleep [insomnias] Delayed sleep phase syndrome .Irregular sleep-wake pattern Delayed sleep phase syndrome. Irregular sleep-wake pattern Other Other Intervention group: Participants in the intervention group were contacted through a virtual social network allowing users to send and receive texts, photos, videos, and audio. The intervention group received supportive training messages on sleep in addition to routine care. The content of the messages was developed as a protocol based on the latest investigations and textbooks on cancer nursing and supportive care and was approved by the oncology department. The messages, including explanations about insomnia management, sleep quality, and strategies to improve sleep quality (sleep health, nutritional advice, place and time of sleep, relaxation techniques, and stress and anxiety management), were sent to the intervention group in two to three text messages with related pictures and audio and video files (8 am to 8 pm) every day for one month. The participants were asked to send the message "the message was read" to the researcher. If the message were not read for more than 24 hours, a reminder message would be sent. To ensure that educational content was understood, the participants were asked two to three questions at the end of each week to obtain feedback. The participants' questions were also answered. After finishing the intervention, the participants were asked to review the sent messages and report their sleep quality for one month. To support the participants, they were constantly monitored and encouraged to perform training. Control group: The control group received routine care. Sleep quality score in the Pittsburgh Sleep Quality Questionnaire. Timepoint: At the beginning of the study (before the intervention) and immediately and one month after the supportive educational intervention. Method of measurement: Pittsburgh Sleep Quality Index questionnaire. Insomnia severity score in Insomnia severity questionnaire. Timepoint: At the beginning of the study (before the intervention) and immediately and one month after the supportive educational intervention. Method of measurement: Insomnia Severity Index Questionnaire. Sleepiness score in the sleepiness Questionnaire. Timepoint: At the beginning of the study (before the intervention) and immediately and one month after the supportive educational intervention. Method of measurement: Eoworth sleepiness Scale Questionnaire. Arak University of Medical Sciences Approved 2019-07-28 Ethics committee of Arak University of Medical Sciences Basij Sq, Payambar Azam University Complex, Arak University of Medical Sciences, Blue Wing, Third Floor, School of Nursing, Arak, Iran Country: Iran Arak Markazi Iran (Islamic Republic of)