Determining the Comparing the effect of Benson's relaxation and mindfulness on the sleep quality of pregnant women
Design
Field trial with control group, with parallel, randomized groups, 102 pregnant women
Settings and conduct
Approval of the research plan in the university ethics committee. At the beginning of the study, complete the demographic characteristics checklist and the Pittsburgh Sleep Quality Index. Intervention group 1: Benson relaxation: the interventions will be carried out according to the protocol, during 8 weeks and 1 day a week. Intervention group 2: Mindfulness: the intervention includes; 8 sessions, the duration of each session will be 1 hour and 1 session per week, for a total of 8 weeks, according to the protocol. immediately after completing the interventions, complete the Pittsburgh Sleep Quality Index. The location of the training is a room in the women's department of Hazrate Zeinab Hospital, in order to maintain the privacy and peace of the participants.
Participants/Inclusion and exclusion criteria
Admission requirements: Being 18-35 years old; monogamy. Conditions of non-entry: Not wanting to continue participating in the study; Previous participation in studies similar to the current research.
Intervention groups
Intervention group 1: Benson relaxation: the interventions will be carried out according to the protocol, during 8 weeks and 1 day a week. Intervention group 2: Mindfulness: the intervention includes; 8 sessions, the duration of each session will be 1 hour and 1 session per week, for a total of 8 weeks, according to the protocol. Control group: non-intervention: this training group will not be given.
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056445N1
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Fatemeh Shams
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3739 5421
Email address
faattii.shams63@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Benson's relaxation and mindfulness on the sleep quality of pregnant women
Public title
Comparing the effect of Benson's relaxation and mindfulness on the sleep quality of pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to communicate and answer questions from patients or patients
Being 18-35 years old
Consent to participate in the study and sign the informed consent form
Having a gestational age of 28-36 weeks (last 3 months of pregnancy) (according to LMP or ultrasound)
Being belly first
monogamy
Exclusion criteria:
Not wanting to continue participating in the study
Previous participation in studies similar to the current research
Lack of inclusion criteria
Suffering from a chronic disease such as: heart disease and diabetes and needing medicine or special care
Suffering from mental illnesses such as depression during the last year
Use of neuropsychiatric drugs and addiction to drugs and cigarettes
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:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Block random assignment will be done in such a way that according to the number of study groups (three groups) consisting of intervention 1 (mindfulness), intervention 2 (Benson's relaxation) and control and calculated based on the factorial law, i.e. 3!= 3×2×1= 6, all the possible arrangement modes of people will be compiled based on the table below, considering A for intervention group 1 (Benson's relaxation), B for intervention group 2 (mindfulness) and C for control group:
1 2 3 4 5 6
CBA CAB BCA BAC ACB ABC
Then, since the estimated sample size was 120 people, in each block, three samples, each representative of a study group and their arrangement order was also different, from these blocks, placement sampling will be done.
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 Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2022-11-08, 1401/08/17
Ethics committee reference number
IR.YUMS.REC.1401.134
Health conditions studied
1
Description of health condition studied
Normal pregnancy
ICD-10 code
z34.8
ICD-10 code description
supervision of other normal pregnancy
Primary outcomes
1
Description
Sleep quality
Timepoint
The amount of sleep quality of pregnant women at the beginning of the study (before the start of the intervention) and immediately after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Benson relaxation: At first, the Benson relaxation method will be taught to the participants in a 60-minute session in groups of 5 to 10 people. Then the interventions will be carried out according to the protocol, during 8 weeks and 1 day a week. Then there will be a telephone follow-up to inform about the exercises at home.
Category
Lifestyle
2
Description
Intervention group 2: Mindfulness: People will be divided into groups of 5 to 10 people. The intervention includes; 8 sessions, the duration of each session is 1 hour and 1 session per week, for a total of 8 weeks, according to the protocol, will be conducted as follows: First session: 1. Introduction of the participants and a brief description of the 8 sessions 2. Eating technique Raisins and then meditate for 30 minutes, scan the body and talk about the feelings caused by doing these meditations. Second session: 1. Body scan and discussion about this experience 2. Doing sitting meditation. The third session: 1. Practicing seeing and focusing on emotions 2. Paying attention to the practice at the moment of doing it, paying attention to breathing and paying attention to the body 3. Three-minute practice of the breathing space. The fourth session: 1. Meditation with attention to breathing 2. Practicing speaking and listening to your feelings. The fifth session: 1. Doing meditation 2. Practicing accepting yourself and your feelings. Sixth session: 1. Practicing breathing space 2. Practicing not judging feelings and events. Seventh session: Meditation and awareness of everything that comes into consciousness at the moment. Eighth session: review of experiences and post-test implementation.
Category
Lifestyle
3
Description
Control group: non-intervention: this training group will not be given.
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
nursing@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Shams
Position
Msc student in Medical-Surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
2nd floor, No. 97, The second sub-right side, 2nd alley, Shahidan Sasani St., Tondgoyan Blvd., Shiraz, Fars, Islamic Republic of Iran
City
Shiraz
Province
Fars
Postal code
7168878831
Phone
+98 71 3739 5421
Email
faattii.shams63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammadlatif Rastian
Position
Academic faculty of Yasuj University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazrat Zeinab College of Nursing, Yasuj University of Medical Sciences, Next to Imam Sajjad Hospital, Yasuj, Kohgiloyeh and Boyerahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7168878831
Phone
+98 74 3323 4115
Fax
+98 74 3333 7230
Email
r115_rastian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Shams
Position
Msc student in Medical-Surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
2nd floor, No. 97, The second sub-right side, 2nd alley, Shahidan Sasani St., Tondgoyan Blvd., Shiraz, Fars, Islamic Republic of Iran
City
Shiraz
Province
Fars
Postal code
7168878831
Phone
+98 71 3739 5421
Email
faattii.shams63@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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