The effect of mindfulness-based counseling and acupressure on sleep quality in pregnant women
Design
Two intervention groups and one control group, sample size of 90 people, we use the block permutation randomization method to randomly place the participants in three groups of 30 people.
Settings and conduct
the health centers and bases covered by the health center of Kashan city
Participants/Inclusion and exclusion criteria
Entry criteria: Iranian, normal pregnancy, Age 18-35 years, gestational age between 16-24 weeks, reading and writing literacy, willingness to participate in the study, Having an unfavorable sleep quality (getting a score of 5 or more later from completing the questionnaire)
Nonentry criteria: not a smoker or drug abuse, and antidepressants and anxiety medications, Having Medical or psychological disease, Abnormal findings in the hands
Intervention groups
The intervention of the first group is counseling based on mindfulness, which includes attending 8 weekly 90-minute training sessions. The intervention of the second group consists of applying pressure with the thumb on the HT7 point (Shenman point) on the pea-shaped bone located in the wrists, for 5 minutes (10 seconds of pressure and 2 seconds of rest) once a night, before going to sleep, for 4 weeks. . The third group (control group) will only receive routine care and training according to the gestational age.
Main outcome variables
Sleep qualihy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230629058620N1
Registration date:2023-07-09, 1402/04/18
Registration timing:prospective
Last update:2023-07-09, 1402/04/18
Update count:0
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
Azam Toranjinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5545 5220
Email address
a.toranjinejad@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of mindfulness- based counseling and acupressure on pregnant women's sleep quality
Public title
Comparison of the effect of mindfulness- based counseling and acupressure on pregnant women's sleep quality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with low-risk pregnancies
Age 18-35 years
Gestational age 16-24 weeks
Literacy for reading and writing
Willingness to participate in the study
Having an unfavorable sleep quality (getting a score of 5 or more after completing the questionnaire)
Exclusion criteria:
Smoker or drug abuse
Taking anti-depressants and anxiety medications
Medical or psychological illness (such as diabetes, chronic hypertension, mental disease, etc.)
abnormal findings in the hands
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize participants into three groups of 30 people (two intervention groups and one control group), we use the block permutation randomization method in order to balance the number of samples allocated in each group, and blocks of 6, with We arrange three letters ABC with equal letters as follows:
block 1: BCACAB and BBCACA block 2: and block 3: BCAABC ..... and so on for different sequences. We select these blocks from the above permutations using random allocation software, which is capable of generating a random sequence by block method, and finally divide them into three groups: A (mindfulness intervention), B (acupressure intervention) and C. (control group) are divided.
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 Arak University of Medical Sciences
Street address
Basij Square (Sardasht), Arak University of Medical Sciences, University Complex of the Great Prophet (PBUH), Deputy for Research and Technology
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
IR.ARAKMU.REC.1402.069
Health conditions studied
1
Description of health condition studied
Sleep quality in pregnancy
ICD-10 code
G47.8
ICD-10 code description
Other sleep disorders
Primary outcomes
1
Description
Sleep quality score
Timepoint
Before the interventions, immediately and one month after the interventions
Intervention group: The intervention of the first group of counseling on mindfulness: which includes 8 weekly 90-minute training sessions in groups (groups of 15 people) that will be delivered to the supervisors and counselors. The researcher will train the mind with the help of teaching and response techniques, role playing, doing class and homework assignments. The sessions will be based on basic training and exercises such as meditation, body scan, mindfulness meditation, and three-minute breathing exercises, etc., which will focus on paying attention to the events taking place in the present and understanding and accepting these events without any judgment and It will teach judgment to pregnant mothers and finally mothers will learn that instead of denying or avoiding negative thoughts and unpleasant events, they accept them and are aware of their reaction to them and show an appropriate reaction in dealing with them. give In the first session, a homework sheet will be provided to mothers, which they must complete weekly. The sessions will be held in the training hall of Kashan health centers, and the researcher who has already completed the specialized counseling course based on mindfulness and will conduct the sessions under the supervision of the clinical psychologist who is a member of the research. In order to evaluate the effectiveness of mindfulness counseling, the participants will be asked to complete the Pittsburgh Sleep Quality Questionnaire after the eighth session and also 1 month after the completion of the mindfulness training sessions.
Category
Other
2
Description
The second group is the acupressure intervention, which is performed in the form of individual and face-to-face acupressure training on the HT7 point (Shen Man point) on the pea-shaped bone of the wrists (in the transverse crease of the wrists in the angle between the pea-shaped bone and the ulnar bone). It will include the pressure applied by the thumb on the mentioned point for 5 minutes (10 seconds of pressure and 2 seconds of rest). After 5 minutes, the same thing is done on the desired point on the other hand. In total, each intervention takes 10 minutes. The pressure is applied for 5 minutes in such a way that the pregnant mother feels warmth, heaviness, swelling or numbness at that point. The process of intervention is 1 time at night, before sleep and for 4 weeks. Before starting the research, the researcher should be trained in acupressure and acquire the necessary skills to find the desired point with 100% accuracy and correctly identify the desired point on 10 participants. The training of the participants in the study regarding the method of finding the desired point and the amount of applying pressure on it will be done verbally and in writing by presenting a pamphlet by the researcher. The participants will be invited to perform acupressure on the mentioned points once in the presence of the researcher so that necessary guidance can be provided if needed. Then the participants in the intervention will complete the Pittsburgh Sleep Quality Questionnaire immediately after the 4-week intervention and 1 month after the end of the intervention. The intervention of this group will be done one month after the intervention of the first group so that the time to complete the Pittsburgh sleep quality questionnaire is the same in all three groups.
Category
Other
3
Description
Control group: receiving routine care and training according to the gestational age and completing the Pittsburgh sleep quality questionnaire at the time of entering the study, 8 weeks later and 12 weeks later.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Development Center of Network Management and Health Promotion of Kashan Health Center
Full name of responsible person
Azam Toranjinejad
Street address
No.17,Tovhid 18 Alley, 22 Bahman Street
City
Kashan
Province
Isfehan
Postal code
8715178145
Phone
+98 31 5545 5220
Email
a.toranjinejad@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpou
Street address
Basij Square (Sardasht), Arak University of Medical Sciences, University Complex of the Prophet (PBUH), Research and Technology Vice-Chancellor
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Fax
Email
dr_hekmat@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Azam Toranjinejad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.17,Tovhid 18 Alley , 22 Bahman Street
City
Kashan
Province
Isfehan
Postal code
8715178145
Phone
+98 31 5545 5220
Email
a.toranjinejad@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fereshteh Farzanazar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Basij Square (Sardasht), Arak University of Medical Sciences, Faculty of Medicine
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3383 8237
Email
farzanazar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam Toranjinejad
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.17, Tovhid 18 Alley , 22 Bahman Street
City
Kashan
Province
Isfehan
Postal code
8715178145
Phone
+98 31 5545 5220
Email
a.toranjinejad@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publication in the article
When the data will become available and for how long
Six months after the end of the study
To whom data/document is available
Health care centers, managers, training centers
Under which criteria data/document could be used
Educational, therapeutic and planning use
From where data/document is obtainable
Public respondent
What processes are involved for a request to access data/document
First, it should be requested and approved by the Research Vice-Chancellor of Arak University of Medical Sciences. Then correspond with the public respondent