The effect of group counseling based on Mindfulness on sleep quality in postmenopausal women Referring to Zanjan Health Center
Design
Clinical trial with control group, parallel design, randomized
Settings and conduct
Counselling sessions will be held in the assistant's room at the Center for Comprehensive Health Services in the city and will be supervised by a consultant's professor.
Questionnaires will be completed before, at the end of the last counselling and eight weeks after the last counseling session in both intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Sleep Disturbance Based on Pittsburgh Sleep Quality Questionnaire in Women With Natural Menopause between 45-60 Years
2) Lack of mental illness (having stress, anxiety and depression based on DASS-21 questionnaire) and lack of chronic physical disease
3) No use of hormonal drugs, radiotherapy and chemotherapy, and medications that affect menstruation over the past six months
4) Having at least guidance school level of eduacation
5) Residence in Zanjan
Intervention groups
Intervention group: The intervention group will be 28 people who will participate in eight 90-minute counseling sessions based on the Mindfulness Approach, under the supervision of a consultant's professor and according to the protocol by the researcher.
Control group: The control group will have 28 people who will not receive any counseling.
Main outcome variables
The quality of sleep in postmenopausal women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160608028352N7
Registration date:2019-04-22, 1398/02/02
Registration timing:retrospective
Last update:2019-04-22, 1398/02/02
Update count:0
Registration date
2019-04-22, 1398/02/02
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based group counseling on sleep quality in postmenopausal women
Public title
The effect of mindfulness-based group counseling on sleep quality in postmenopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Sleep disturbance based on Pittsburgh Sleep Quality Questionnaire in women with natural menopause between 45-60 Years
Having at least a guidance school level of education
Residence in Zanjan
Exclusion criteria:
Having mental illness (having stress, anxiety and depression based on DASS-21 questionnaire) and chronic physical disease
Use of hormonal medicines, radiotherapy, and chemotherapy, and medications that affect menstruation over the past six months
Age
From 45 years old to 60 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
Participants will assigned into two groups of intervention and control using blocked randomization method. Blocks of four-dimensional size will be created, and in each block, half of the participants will be in the intervention group and the other half will be in the control group, randomly. All possible clip of the participants in the blocks will predicted and the blocks number will selected from random table numbers. Selection of the blocks will continue to reach the determined sample size of 28 people in the intervention group and 28 in the control group.
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 Zanjan University of Medical Sciences
Street address
North side Azadi Boulevard Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.ZUMS.REC.1397.276
Health conditions studied
1
Description of health condition studied
Sleep quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
The sleep quality
Timepoint
Before intervention , immediately after intervention, and two months after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
1
Description
Quality of life in the postmenopausal women
Timepoint
Before intervention , after intervention and two months after intervention
Method of measurement
Questionnaire of the quality of life of postmenopausal women
Intervention groups
1
Description
28 participants in the control groups who will not receive any counseling.
Category
N/A
2
Description
Individuals in the intervention group will given eight sessions of one and a half hours based on mindfulness group counseling, all of which will be provided by the researcher. The number of sessions was determined according to the studies that were conducted using a similar counseling approach to the intervention of the researcher. Counselling sessions will organized in the assistant's room under the supervision of the assistant professor. The counselling protocol will be based on the mindfulness approach on the sleep quality.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urban comprehensive health center in Zanjan City
Full name of responsible person
Sima Kakavand
Street address
Urban comprehensive health center in Zanjan City
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
Kakavand.Sima@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shaghli
Street address
Chancellor for Research and Technology of Zanjan University of Medical Sciences,First floor, North side Boulevard Azadi, zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
r.kharaghani@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Sima Kakavand
Position
student Masters Midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road, Zanjan