Protocol summary
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Study aim
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To compare the effect of education on continuous care model and tele-care (telehealth) model on the quality of sleep in pregnant women
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Design
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Three groups of clinical trials with a control group, community based and pragmatic, parallel groups,no blind, randomized.
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Settings and conduct
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This randomized, three-group study was performed in Mashhad's health centers.
After confirmation of the research by the Ethics Committee of Mashhad University of Medical Sciences and expressing the goals of studying and satisfying the pregnant women and obtaining written consent from them, and taking into account ethical codes, the sample was selected and carried out.
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Participants/Inclusion and exclusion criteria
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Women aged 35-18;Pregnancy with one fetus with gestational age of 16 to 20 weeks and 5 scores or more in the Pittsburgh Sleep Quality Questionnaire (PSQI).
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Intervention groups
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For the follow-up care group,first an introductory meeting (familiarization) will be held, then 4 sessions will be held in 4 weeks, and communication with his family will be established by telephone and booklet (sensitization). Then, within three weeks, a 10-minutes phone call will be established (control) and, finally, the quality of sleep will be reviewed immediately and 4 weeks later (a total of 12 weeks). In the telehealth group, an awareness session is initiated first, then 4 encoded CDs are provided to mothers and it is recommended that you watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks ), Telephone counseling is done for 10-15 minutes (once a week) and the quality of sleep will be assessed immediately and 4 weeks after the intervention (a total of 12 weeks). For the control group, the usual care was taken by the health centers.
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Main outcome variables
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Sleep quality in pregnant women
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017060734378N1
Registration date:
2017-07-15, 1396/04/24
Registration timing:
prospective
Last update:
2018-05-12, 1397/02/22
Update count:
1
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Registration date
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2017-07-15, 1396/04/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Contact Number 38411538-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad.
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Expected recruitment start date
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2017-07-23, 1396/05/01
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Expected recruitment end date
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2018-02-19, 1396/11/30
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Actual recruitment start date
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2017-07-23, 1396/05/01
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Actual recruitment end date
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2018-02-19, 1396/11/30
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Trial completion date
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empty
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Scientific title
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Comparing the effect of training, based on continuous care model and a telehealth on pregnant women sleeping quality
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Public title
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Comparing the effect of training, based on continuous care model and a telehealth on sleeping quality
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
have Spontaneous written consent
Being Iranian and resident of Mashhad
The gestational age is between 16 and 20 weeks
Pregnancies with one fetus
Mother`s age between 18 to 35
The least literacy of mother and her husband be about fifth grade elementary school
In response to the Pittsburgh Sleep Quality Questionnaire, she earns 5 scores and more
In response to the restless leg assessment Questionnaire, she earns 3-0 scores
In response to STOP Questionnaire , she earns 2-0 scores
In response to question 1, the intensity of ISI Questionnaire , she earns 0-5 scores
In response to stress , anxiety and depression Questionnaire less than 10, 14, and 17 scores were obtained from depression, anxiety and stress levels;
Having fixed or mobile phone numbers
Exclusion criteria:
linguistic, audio or dialectal problems
Having sleep disorders history before pregnancy
A bad important event has been occured from three months before the commencement of the study
Having medical disease
Having mental illness
Having midwifery problems
Having history of infertility and the current pregnancy does be a result of infertility treatment
Pre-pregnancy BMI does be equal to or greater than 30
Having addiction to tobacco (hookah, cigarettes, cheeks, drugs) or alcohol and psychosocial drugs, research unit or his husband
During the research she does have night shift work
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
Actual sample size reached:
91
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The name of the center has been used to randomize the lottery method.
Lottery in the name of health centers has been done to locate each group in each health facility.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-06-03, 1396/03/13
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Ethics committee reference number
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IR.MUMS.REC.1396.68
Health conditions studied
1
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Description of health condition studied
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Sleep
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ICD-10 code
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G47.0
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ICD-10 code description
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Disorders of initiating and maintaining sleep [insomnia]
Primary outcomes
1
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Description
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Sleep quality
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Timepoint
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Before the intervention, immediately after intervention and 4 weeks after intervention
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Method of measurement
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Pittsburgh Sleep Quality Index
Secondary outcomes
1
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Description
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Severe insomnia
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Timepoint
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Before, immediately after and 4 weeks after intervention
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Method of measurement
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Insomnia Severity Index
Intervention groups
1
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Description
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Control group: usual care health center receives over 8 weeks
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Category
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N/A
2
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Description
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Intervention 2: In the Telehealth group, first they become familiar with the stages of the research between the 16th to 20th weeks of pregnancy (30-45 minutes), then 4 coded CDs (60-65 minutes) with the contents of the health and healthy behaviors during sleep is given to moms and they will be advised to watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks), telephone counseling is provided for 10-15 minutes based on the need of the patient (once a week ), Each telephone consultation includes 2 sections, the first part of the consultation is based on the content of the weekly CD, and the second part will be dedicated to the specific needs of each client and the presentation of proposed solutions. Then, the quality of sleep will be evaluated immediately and 4 weeks after the intervention (totally 12 weeks).
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Category
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N/A
3
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Description
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Intervention 1: In the group which its education is based on continuous care model, in first meeting (45-30 minutes) pregnant women in 16 to 20 weeks of pregnancy with a family member, after completing the survey device, become familiar with the research steps (orientation) then four 90-60 minutes sessions with consultation, discussion and Q & A ,with the contents of the health and healthy behaviors during sleep are held in 4 weeks and communication with his family is established by phone and booklet(sensitization ).If, it is needed, to study new problems, maintaining connection with mother, answer to her questions and review the lists some meetings with phone calls (10 minutes)will be held (control) and in the evaluation phase, sleep quality will be discussed immediately and 4 weeks later (totally 12 weeks)
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available