Determining the effect of educational application on sleep disorders in postmenopausal women
Design
A clinical trial with a control group, with randomized parallel groups without blinding, phase two on 60 postmenopausal women. Blocks of four and two-by-two allocation are used for randomization using computer software.
Settings and conduct
people who are eligible to participate in the study based on the relevant questionnaires (getting a score of 7 or more from the Insomnia Severity Index Questionnaire, a score of more than 5 from the Pittsburgh Questionnaire),in the city of Ahwaz in order to carry out the intervention, will be randomized into two groups of 30 people, the intervention group and the control group. before the start of the intervention, the researchers and the participants do not know about the grouping of the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Obtaining a score lower than the cut-off point in the sleep .disorder. questionnaire. Reading and writing literacy. Having a smart phone
Exit criteria: Having a chronic disease leading to insomnia, such as rheumatoid arthritis. The presence of known mental illnesses. History of frequent use of sleeping pills. Addiction to smoking or drug abuse. Major stressors in the last 3 months such as loss of loved ones and divorce .Employment in jobs with shift work, especially night work. People with a BMI >29.People with a score of more than 29 from the Beck questionnaire and more than 30 from the Hamilton questionnaire
Intervention groups
For people in the intervention group, an educational application for improving sleep disorders is installed on mobile phones. People in the control group are given an educational pamphlet to improve sleep disorders.
Main outcome variables
Improvement of Pittsburgh Sleep Disorder Index Score and Sleep Quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240906062963N1
Registration date:2024-10-01, 1403/07/10
Registration timing:prospective
Last update:2024-10-01, 1403/07/10
Update count:0
Registration date
2024-10-01, 1403/07/10
Registrant information
Name
Elham Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 9822
Email address
safari.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-11, 1403/08/21
Expected recruitment end date
2025-03-11, 1403/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of an educational application to improve sleep disorders in postmenopausal women
Public title
Determining the effect of educational application on sleep disorders in postmenopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the project and have a written consent
Obtaining a score lower than the cut-off point in the sleep disorder questionnaire
The duration of menopause is 1-5 years
Reading and writing literacy
Having a smart phone
Getting to know how to use a smart phone
Exclusion criteria:
People with a score of more than 29 from the Beck questionnaire and more than 30 from the Hamilton questionnaire
Having a chronic disease leading to insomnia, such as rheumatoid arthritis
The presence of known mental illnesses
History of frequent use of sleeping pills
History of frequent use of sleeping pills
Major stressors in the last 3 months such as loss of loved ones and divorce
Employment in jobs with shift work, especially night work
People with a BMI >30
People with a score of more than 29 from the Beck questionnaire and more than 30 from the Hamilton questionnaire
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, through a cluster and referring to the existing files, and through phone calls or after visiting the clinics in person .using computer software, they will be divided into two groups of 30 intervention and control. The codes assigned to each participant are written on a piece of paper and kept by the secretary of the center. Therefore, before the start of the intervention, the researchers and the participants do not know about the grouping of the participants.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A clinical trial with a control group, randomized, with allocation to groups in blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan Felake
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2024-08-31, 1403/06/10
Ethics committee reference number
IR.AJUMS.REC.1403.251
Health conditions studied
1
Description of health condition studied
Sleep Disorder
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Improving indicators of sleep disorders
Timepoint
Before starting the intervention and The beginning of the intervention 4 and 8 weeks after using the application
Method of measurement
Insomnia Severity Index Questionnaire, Pittsburgh Sleep Quality Index Questionnaire, daily sleep data registration form
Secondary outcomes
1
Description
Anxiety score
Timepoint
Before the intervention and 4 and 8 weeks after using the application
Method of measurement
Hamilton anxiety questionnaire
Intervention groups
1
Description
Intervention group: We run the educational application for improving sleep disorder on the mobile phone of one of the participants in the intervention group to ensure that it works properly. After installing the software on the mobile phone of the women in the intervention group, the researcher at least twice a week from He communicates with the participants through phone calls or text messages, and if there is any ambiguity, he provides necessary explanations for a better understanding of the educational materials .Moreover, they can call privately and solve their problems. For the control group, an educational pamphlet will be considered. In order to evaluate the progress of the treatment, the necessary examinations will be conducted 4 weeks after the start of the intervention and immediately after the end of the intervention, which is one month later, and also one month after the end of the intervention to follow up the results. The treatment will be done, the relevant questionnaires will be completed and they will be evaluated for statistical analysis