Determination of the effect of mindfulness based group counseling on the sleep quality of pregnant women
Design
Controlled randomized controlled trials, with a two-group research project (intervention and control), a post test & pretest, with a sample size for each group of 20 people.
Settings and conduct
By referring to the Golha health centers in Gorgan; and according to inclusion and exclusion criteria for this study, the subjects selected via accessible sampling؛ If they would like to participate in the study and Based on permuted block randomization via random sequence generation sampling method, will be randomly assigned to both control and intervention groups. Meanwhile, both groups will be included in the study the same times.
Participants/Inclusion and exclusion criteria
Entry requirements:
Pregnancy women who are on the basis of the date of the last menstruation or ultrasound, at least 14 weeks of pregnancy and up to 24 weeks.
Pregnant women with poor sleep quality
Non-arrival conditions:
use of sleep medications and housing
Participate in similar training courses in pregnancy
Intervention groups
The intervention group: will be mind-boggling in groups of 6 to 12, in the course of 8 sessions per week, 120 minutes. Control group: Without receiving any intervention, after completing the first stage of the questionnaire, 8 and 12 weeks later, they will be examined for sleep quality.
Main outcome variables
quality of sleep during pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180408039229N1
Registration date:2018-08-03, 1397/05/12
Registration timing:registered_while_recruiting
Last update:2018-08-03, 1397/05/12
Update count:0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Narjes Sadat Borghei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 9718
Email address
dr.borghei@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of mindfulness group based counseling on sleep quality in nulliparous pregnant women
Public title
Evaluation of mindfulness on sleep quality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous Pregnant women
Gestational age between 14 to 24 weeks.
Pregnant women with poor sleep quality that score 5 or more than 5 of the Pittsburgh Sleep Quality Index.
Have read and write literacy.
By the end of pregnancy, they should be residents of Gorgan.
fluent in Farsi
Exclusion criteria:
Experience a severe stressful event during the past 3 months (eg accident accident, the death of one of the first-degree relatives)
High-risk pregnancy based on the country's guidelines for the provision of obstetric and obstetric services
The use of hypnotic and analgesic drugs
Participate in similar training courses in pregnancy (such as attending special pregnancy classes)
infertility History
drug misuse, psychotropic or alcohol abuse
woman having a known psychological illness and the use of psychiatric drugs or physical illnesses (cancers) and chronic diseases in the last few months
shift in working hours and night work
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Restricted randomization with block randomization permuted
Random unit: Individual
permuted block randomization via random sequence generation. For this purpose scores is arranged in ascending order and placed between two and two to the control and test groups.
also In the randomization process, the person involved in the creation of a random program will be distinct from other researchers, to reduce the probable bias.
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
Ethics Committee of Golestan University of Medical Sciences
Street address
Research Deputy of Golestan University of Medical Sciences, Beginning of the Road of Shasta Kalateh., 5th Km of Gorgan Kurdkuy Road
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
ir.goums.rec.1396.286
Health conditions studied
1
Description of health condition studied
poor sleep quality during pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sleep quality during pregnancy
Timepoint
Before the intervention, the end of the intervention and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will counsel in 6 to 12 people, 120 consecutive minutes will be subject to group counseling during the 8 weekly sessions.Session 1: Participants are asked to introduce themselves at the first meeting. The researcher will give them a brief summary of 8 sessions. Afterwards, participants will be asked eating a raisin number with all the emotions and discussing this feeling in the future. Body scan is then performed for 30 minutes. Second session: Participants will encourage their body scans to meditate, and discuss their experiences with their homework experience. After that, discussing the barriers to practicing and solving the mindfulness program is discussed. Then discusses the difference between thoughts and feelings and finally meditate in a sitting position.Session 3: Begins with the practice of seeing and hearing. In this exercise, participants are asked to look in a non-judgmental fashion for 2 minutes and listen. At the fourth session, with attention to breathing, body sounds and thoughts begin. In the following, discuss stress responses and one's reaction to difficult situations and alternative behaviors, and at the end of the session, walking into the conscious mind is practiced. At the fifth session, participants are asked to take meditation sessions. In the second part of the second cycle, the conscious movements of the body are presented and implemented. The sixth session begins with a three-minute breathing exercise. After that, the practice is presented with this theme: the content of the thoughts are not mostly real. Seventh session begin With a four-dimensional and intelligible mediation, he will be alert to everything at the moment.The theme of this meeting is: What is the best way to self care? Session 8: After performing meditation, body scan and 3-minute breathing exercises; the methods of coping with barriers to mediation is discussed. Then, in the case of the whole session, questions about what do participants feel that their coping skills have increased and whether they want to continue their meditation exercises; it will be discussed.
Category
Behavior
2
Description
Control group: There is no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Golha health centers
Full name of responsible person
Niazy, Somayeh
Street address
Golha health center., No.1, Golbarg., Golha street., Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
smyh.nz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
honarvar, Mohammad Reza
Street address
Research Deputy of Golestan University of Medical Sciences., Beginning of the Road of Shasta Kalateh., 5th Km of Gorgan Kurdkuy Road
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1660
Fax
+98 17 3242 1657
Email
smyh.nz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?