Determining the impact of cognitive-behavioral counseling based on mindfulness on the sleep quality of primiparous mothers in the postpartum period
Design
After selecting the samples, they will be divided into two groups using a random block of 6 and with an allocation ratio of 1.1. Each of the blocks will have 3 people from the control group and 3 people from the intervention group. It is random.
Settings and conduct
Samples are collected in 17 Shahrivar and Abu Dhar centers. The samples will be selected from among the mothers who are eligible and who meet the entry criteria and do not have the exit criteria. To hide the random allocation, the type of intervention will be written on paper and placed inside the opaque envelopes numbered consecutively. In this way, the researcher and the participant will not know the type of intervention until the start of the intervention. Due to the nature of this study, blinding will not be possible.
Participants/Inclusion and exclusion criteria
Entry conditions: primiparous mothers 6 months after giving birth - mothers with poor sleep - absence of any mental and physical illness - natural and uncomplicated birth - birth of a healthy and mature baby - singleton - exclusive breastfeeding - at least the end of primary school education - Age range - 1 to 40 years - proficient in Persian language
Conditions of non-entry: postpartum depression - hospitalization of the baby for any reason - suffering from an acute febrile illness during research - suffering from chronic diseases such as diabetes
Intervention groups
This research is a type of clinical trial intervention that investigates the effect of cognitive-behavioral counseling based on mindfulness on the quality of sleep of mothers with first-born children in the postpartum period.
Main outcome variables
Sleep quality in the Pittsburgh Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230718058833N1
Registration date:2023-08-29, 1402/06/07
Registration timing:prospective
Last update:2023-08-29, 1402/06/07
Update count:0
Registration date
2023-08-29, 1402/06/07
Registrant information
Name
Simin Khezri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3353 5404
Email address
khezri.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-03, 1402/06/12
Expected recruitment end date
2024-01-02, 1402/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cognitive-behavioral counseling based on mindfulness on the sleep quality of primiparous mothers in the postpartum period
Public title
Investigating the effect of cognitive-behavioral counseling based on mindfulness on the sleep quality of mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous mothers six months after delivery
Absence of any mental or physical illness
Natural birth without complications
The birth of a healthy and mature baby
monogamy
Exclusive breastfeeding
Minimum education at the end of elementary school
Age range from 18 to 40 years
Proficient in Persian language
Exclusion criteria:
Postpartum depression (getting a score above 5.12 from the Edinburgh Depression Questionnaire)
Hospitalization of the baby for any reason
Getting an acute febrile illness during research
Having chronic diseases such as diabetes
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial selection of the samples, they will be divided into two groups using a random block of 6 and with an allocation ratio of 1.1. In each of the blocks, 3 people will be in the control group and 3 people will be in the intervention group. He is a random person.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In order to hide the random allocation, the type of intervention will be written on paper and placed inside opaque envelopes numbered consecutively, in this way, the researcher and the participant will not know the type of intervention until the intervention begins. This study will not be able to blind the researcher and the participant.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Golestan St., Jundishapur University of Medical Sciences, Ahvaz, Nursing and Midwifery College
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.AJUMS.REC.1402.289
Health conditions studied
1
Description of health condition studied
Sleep quality
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Sleep quality in the Pittsburgh Questionnaireاب
Timepoint
At the beginning of the study, week 8 (immediately after the intervention), week 12 after the intervention (one month after the intervention)پ
Intervention group: The intervention group will be divided into 4 groups, then the intervention will be carried out in the form of a pre-test, post-test and follow-up stage, so that all the mothers of the intervention and control groups at the beginning of the study, week 8 and week 12 after the intervention of the sleep quality questionnaire will be completed by self-reporting.The purpose of this study is to determine the effectiveness of cognitive-behavioral counseling based on mindfulness on the sleep quality of primiparous mothers in the postpartum period. and if they have entry criteria and no exit criteria, the samples will be selected, at first, each eligible person will be given the same explanation about the objectives of the research and how to intervene. Completing the demographic questionnaire, the Edinburgh Depression Scale and the sleep quality questionnaire by Samples that meet the conditions for entering the study will be conducted. Counseling will be conducted by a trained researcher under the supervision of a consultant professor at the center. The women of the intervention group will undergo 8 group counseling sessions (1 session per week) with a cognitive therapy approach based on Mindfulness will be aimed at improving the quality of sleep. Sessions will be held in groups, one 45-minute session per week for 2 months according to the plan between the consultant and the clients.
Category
Behavior
2
Description
Control group: Control group: This group consists of 49 people. In each of the blocks, 3 people will belong to the control group and 3 people will belong to the intervention group, and the order of placement of each person is random. Low sleepers will not receive any intervention, in order to comply with ethical standards, they will be given a training booklet and a summary of the contents of the sessions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Seventeen Shahrivar Health Center
Full name of responsible person
Dr. Naheed Javadi Far
Street address
Thirty meters, Rostagari Street, Gandami Street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
nahidjavadifar_341@yahoo.com
2
Recruitment center
Name of recruitment center
Abu Dhar Health Center
Full name of responsible person
Dr. Naheed Javadi Far
Street address
Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Phone
+98 61 3373 8331
Email
nahidjavadifar_341@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zaker Kish
Street address
Ahvaz Academic City - Research and Technology Vice-Chancellor of Jundishapur University of Medical Sciences, Ahvaz - ground floor
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Phone
+98 61 3333 3477
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
Dr. Naheed Javadi Far
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Khuzestan, Ahvaz, Golestan St., Jundishapur University of Medical Sciences, Ahvaz Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Phone
+98 61 3373 8331
Email
Nahidjavadifar_341@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Naheed Javadi Far
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Khuzestan-Ahvaz-Jandishapur University of Medical Sciences, Ahvaz Faculty of Nursing and Midwifery