Objectives: To compare the effect of education on continuous care model and tele-care (telehealth) model on the quality of sleep in pregnant women.
Study design: clinical trial.
Setting and conduct: 90 pregnant women who refere to health centers of Mashhad will be randomly assigned to three groups of continuous care model, telehealth and control. Each health center will be assigned to one of these three groups listed.
Main conditions for participants to enterance to or exiting from the study : Women aged 35-45;Pregnancy with one fetus with gestational age of 16 to 20 weeks and 5 scores or more in the Pittsburgh Sleep Quality Questionnaire (PSQI).
Intervention: 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).
Main outcome variables: Sleep quality in pregnant women
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060734378N1
Registration date:2017-07-15, 1396/04/24
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-07-15, 1396/04/24
Registrant information
Name
Fatemeh Jalalmarvi
Name of organization / entity
Islamic Azad University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3751 5211
Email address
jalalmarvif941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Contact Number 38411538-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad.
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of training, based on continuous care model and a telehealth on pregnant women sleeping quality
Public title
Comparing the effect of training, based on continuous care model and a telehealth on sleeping quality
Purpose
Health service research
Inclusion/Exclusion criteria
including major eligibility criteria: Spontaneous written consent; Being Iranian and resident of Mashhad; Absence of linguistic, audio or dialectal problems; Gestational age 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 Abnormal Sleep Apnea, she earns 2-0; In response to question 1, the intensity of sleeplessness score, 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 no sleep disorders history before pregnancy; A bad important event has not been occured from three months before the commencement of the study; Having no medical disease and also no mental illness; No midwifery problems;Having no history of infertility and the current pregnancy does not be a result of infertility treatment; Pre-pregnancy BMI does not be equal to or greater than 30;Having no addiction to tobacco (hookah, cigarettes, cheeks, drugs) or alcohol and psychosocial drugs, research unit or his husband; During the research she does not have night shift work; Having fixed or mobile phone numbers. Exclusion criteria from study: Unwillingness to continue the participant in the study; Midwifery problems occure during the study; Major bad events occure during the study; Participate in classrooms or training programs about sleeping; Delivery during the study; Doing some actions like traveling or changing the address during the study; In a follow-up care-based education group, a family member does not participate in the "familiarization" session or does not have the necessary cooperation with the researcher during the intervention ; In a follow-up care-based group, the research unit does not participate in one of the sessions; Have a history of hospitalization during the study period; Having disorders during pregnancy.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Contact Number 38411538-051; Fax Number 38430249-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad
City
Mashhad
Postal code
91388-13944
Approval date
2017-06-03, 1396/03/13
Ethics committee reference number
IR.MUMS.REC.1396.68
Health conditions studied
1
Description of health condition studied
Sleep
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnia]
Primary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention, immediately after intervention and 4 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
Severe insomnia
Timepoint
Before, immediately after and 4 weeks after intervention
Method of measurement
Insomnia Severity Index
Intervention groups
1
Description
Control group: usual care health center receives over 8 weeks
Category
N/A
2
Description
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).
Category
N/A
3
Description
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)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iesargaran health center
Full name of responsible person
Dr. Tabibzadeh
Street address
Hedayat 1, Hedayat Blvd
City
Mashhad
2
Recruitment center
Name of recruitment center
Imam Reza health centers
Full name of responsible person
Dr. Mohammad javad Jamal khoo
Street address
45th Resalat; Resalat Street
City
Mashhad
3
Recruitment center
Name of recruitment center
Nikanam health center
Full name of responsible person
Dr. Asna ashari
Street address
Hojjati clinic; Hojjat alley; Ebadi Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Contact Number 38411538-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Jalalmarvi
Position
Counseling in Midwifery student
Other areas of specialty/work
Street address
Ibn Sina street; Doctora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Jalalmarvif941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masumeh Kordi
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ibn Sina street; Doctora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Kordim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Jalalmarvi
Position
Counseling in Midwifery Student
Other areas of specialty/work
Street address
Ibn Sina street; Doctora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Jalalmarvif941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)