Determining the effect of mindfulness-based delivery and parenting program on sleep quality of pregnant mothers with sleep disorders
Design
The interventional study is a pre-test-post-test in control and intervention Fifty-six pregnant women were divided into four groups of 23 controls and 23 intervention groups In order to hide the allocation, the numbers of the intervention and control groups are given to the group manager in blocks, respectively. People choose without seeing the numbers and are placed in groups of 8 people.
Settings and conduct
The study will be performed on 56 pregnant women with sleep disorders in East Ahvaz clinic as a clinical trial with two control and intervention groups. Who meet the inclusion criteria will be completed. and after obtaining written consent, the Pittsburgh Demographic Information Questionnaire and Sleep Quality Questionnaire will be completed by individuals who meet the inclusion criteria.
Participants/Inclusion and exclusion criteria
Being single
Age 18 to 35 years
Uncomplicated pregnancy (blood pressure, diabetes and other diseases)
Lack of infertility
Lack of chronic and underlying disease
No depression and mental illness
No addiction and no severe mental accident during the last 6 months
absence from classes
Participate in meditation and mindfulness classes at the same time
Addiction
Intervention groups
Meetings are held once a week on a specific day and time in the counseling room, in groups for 1.5 hours. And after the sessions, the post-test is held in both groups. Counseling and training in this research will be done in groups by the researcher (Master of Counseling in Midwifery) who has participated in a mindfulness training course and obtained the necessary certificate.
Main outcome variables
Improving the sleep quality of pregnant mothers
Reduction and boredom during the day
Reduce the risk of insomnia or lack of sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220421054602N1
Registration date:2022-05-02, 1401/02/12
Registration timing:prospective
Last update:2022-05-02, 1401/02/12
Update count:0
Registration date
2022-05-02, 1401/02/12
Registrant information
Name
Aysouda Azimi Igdir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3654 1457
Email address
aysou.igdir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-15, 1401/02/25
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a mindfulness-based childbirth and parenting program on sleep quality of pregnant mothers with sleep disorders
Public title
Effects of a mindfulness-based childbirth and parenting program on sleep quality of pregnant mothers with sleep disorders
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being single
Age 18 to 35
Uncomplicated pregnancy (blood pressure, diabetes and other diseases)
Lack of infertility
Lack of chronic and underlying disease
No depression and mental illness
No addiction and no severe mental accident during the last 6 months
Exclusion criteria:
Participate in meditation and mindfulness classes at the same time
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the intervention to individuals is randomly divided into 4 groups of random permutation blocks with a random block size of 4 using the table related to random permutations and intervention and control. Randomization list prepared by a statistician To hide the allocation of individuals in the two intervention and control groups, 23 four-digit pairs will be selected as the codes of the participants in the control group and 23 4-digit individuals as the codes of the participants in the intervention group will be selected from a random number table. The numbers of intervention and control groups are written, then the blocks are placed in sealed envelopes, respectively, and are randomly delivered by one of the personnel to the qualified people to participate in the study. The researcher and the participant until the last moment They will not be aware of the type of allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ahvaz University of Medical Sciences
Street address
Ahvaz Golestan Highway, Jundi Shahpour University of Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2022-04-09, 1401/01/20
Ethics committee reference number
IR.AJUMS.REC.1401.022
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
sleep disorder
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Demographic Information Questionnaire and Pittsburgh Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: No intervention is performed, only routine pregnancy care
Category
Treatment - Other
2
Description
Intervention group: Mindfulness counseling sessions are held once a week on a specific day and time in the counseling room, in groups and for 1.5 hours. After the sessions, post-test is held in both groups. However, in the control group, no training and counseling is given. The mindfulness-based cognitive therapy counseling model is adapted from the stress reduction model based on the Kabat-Zayn mindfulness method and the method based on childbirth and parenting that the principles of treatment Cognitive is added to it. In this study, the cognitive content of the sessions will be presented in a simple language and appropriate to the participants' level of understanding about the causes of sleep problems and symptoms and symptoms of insomnia, as well as treatment and reduction of sleep problems in pregnant women and childbirth and parenting.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
East Ahvaz Health Center
Full name of responsible person
Amraleh Mardani
Street address
East Ahvaz Health Center، Opposite Haft Tir ParkAyatollah Behbahani Highway - Shahid Rastegari St.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 5633
Email
info@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakir Kish
Street address
Ahvaz, University City, Vice Chancellor For Research And Technology, Ahvaz Jundishapur University Of Medical Sciences And Health Services, Ground Floor
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Fax
Email
zakerkish-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jundi Shahpour University Of Ahvaz, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 916 612 1693
Email
Nahidjavadifar_341@Yahoo.Com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz Golestan Highway, Jundi Shahpour University Of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 916 612 1693
Email
Nahidjavadifar_341@Yahoo.Com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Aysouda Azimi Igdir
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hengam Alley No. 6/2, Niayesh St., Shiraz
City
Shiraz
Province
Fars
Postal code
71948555543
Phone
+98 713 36541457
Email
Aysou.Igdir@Gmail.Com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available