Protocol summary

Study aim
By examining the effect of sleep hygiene education on sleep quality and mental health in patients with substance abuse, we can take effective steps to improve sleep and mental health skills in patients with drug abuse, to lessen the incidence of insomnia. And fall ill.
Design
Controversial, community-based, and pragmatic clinical trials, with parallel, one-blind, randomized, randomized groups
Settings and conduct
Study in outpatient rehabilitation centers for people with substance abuse and drug abuse centers in Isfahan is available in 70 patients. Sleep quality questionnaire (PSQ) and mental health (DASS-21) are completed before intervention, one month after the intervention and three months after the intervention in both groups. The data analyst is unaware of the educational content and grouping. .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inclination to participate in the study, aged over 18, having reading and writing skills, drug abuse, confirmed by positive urine test, and PSQI score higher than 5 Non-Inclusion criteria: Adolescents are adolescents with acute psychiatric disorders such as psychosis, diphtheria, schizophrenia. Exclusion criteria: Patients in any case do not wish to continue to participate in the study, or there is a crisis or unexpected incident during their research. Failure to participate at least two educational sessions and changes in treatment overkill for any reason during the intervention and questionnaires that at least 20% have not been completed are removed and replaced with other patients.
Intervention groups
In the intervention group, 35 people are randomly assigned to four sessions of counseling by a trained psychologist to discuss sleep hygiene and how to improve sleep quality.
Main outcome variables
Study of the Effect of Group Healthy Sleep Health Education on Sleep Quality and Mental Health in Patients with Substance Abuse

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171230038142N2
Registration date: 2018-10-17, 1397/07/25
Registration timing: registered_while_recruiting

Last update: 2018-10-17, 1397/07/25
Update count: 0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Sleep Hygiene Education on sleep quality and mental health in patients with substance abuse and comparison with the control group
Public title
The effect of Sleep Hygiene Education on sleep quality and mental health in patients with substance abuse
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the research Age more than 18 years Having reading and writing skills Substance abuse confirmed by positive urine test. PSQI score higher than 5
Exclusion criteria:
An addict is a teenager. Acute psychiatric disorders such as psychosis, diphtheria, schizophrenia.
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done by available method in rehabilitation centers and ambulatory outpatient treatment centers with a selection of 70 people, in which 35 individuals were randomly assigned to a control group using a random number table and 35 subjects in the intervention group they got. Subsequently, 4 training sessions of 60-90 minutes were conducted with scheduled educational content for the intervention group by a trained psychologist.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data was uncovered by the data analyst with the name of the first group (control) and the second group (intervention). He also did not know the educational content.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jereyb St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.MUD.MED.REC.1397.009

Health conditions studied

1

Description of health condition studied
The effect of Sleep Hygiene Education on sleep quality and mental health in patients with substance abuse
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
A study on the effect of sleep hygiene education on sleep quality and mental health in patients with substance abuse through mental health questionnaire (DASS-21) and sleep quality (PSQ). Both questionnaires have a score of 21-0. The higher the rating represents the higher the quality.
Timepoint
Before the intervention begins, one month after the intervention and three months after the last intervention session.
Method of measurement
The score obtained from the mental health questionnaire (DASS-21) and sleep quality (PSQ) in the three stages before the one month after the start and three months after the intervention. Each of the two questionnaires has a score of 21-0. The higher the rating represents the higher the quality.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Received 4 sessions of 60-40 minute group training on the effect of sleep hygiene on the quality of sleep and mental health in patients with drug abuse
Category
Rehabilitation

2

Description
Control group: Did not receive training.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation centers and outpatient treatment centers in Isfahan
Full name of responsible person
Zahra Amini
Street address
Isfahan University of Medical Sciences, Hezar Jereyb St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
zahraamini63@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Amini
Street address
Isfahan University of Medical Sciences, Hezar Jereyb St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
+98 31 3668 0048
Email
zahraamini63@gmail.com
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
Zahra Amini
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jereyb St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
+98 31 3668 0048
Email
zahraamini63@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jereyb St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
+98 31 3668 0048
Email
zahraamini63@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jereyb St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
+98 31 3668 0048
Email
zahraamini63@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information can be shared with the permission of the research and student vice president of Isfahan University of Medical Sciences after being unidentifiable.
When the data will become available and for how long
Two years after the publication of the results and after obtaining permission from the Research and Student Vice-Dean of Isfahan University of Medical Sciences is available.
To whom data/document is available
Students and professors of the Department of Medicine, Psychology and Consultation
Under which criteria data/document could be used
If the results are compared with the next results or any research that is similar or in line with the continuation of the study.
From where data/document is obtainable
After informing the email zahraamini63@gmail.com and with the permission of the research and student vice president of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Sending a request to e-mail zahraamini63@gmail.com and obtaining permission from the Research and Student Vice-Dean of Isfahan University of Medical Sciences.
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