The effectiveness of Mindfulness-Based Stress Reduction (MBSR) on the rate of depression, anxiety, stress, and the perception of low back pain after childbirth
The purpose of this study was to investigate the effectiveness of mindfulness on the rate of depression, anxiety, stress, and the perception of low back pain in women after their childbirth.
Design
This study was a semi-experimental design with control group, community-based, with a sample size of 40 patients and randomized.
Settings and conduct
The location of the study was sa'adat abad health center in Tehran and the study was done on women with low back pain after childbirth. for sampling and randomization, the women were divided into two groups, namely experimental and control. Eight sessions of the mindfulness program were conducted for the experimental group.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Having back pain after three months from the childbirth
Having chronic back pain due to childbirth
- Exclusion criteria
Having mental disorders
Receiving simultaneous psychotherapy or medical treatment for low back pain
Intervention groups
The mindfulness training program was carried out in 8 sessions once every week. Each session took 120 minutes for the experimental group. The control group did not receive intervention.
Main outcome variables
Depression, Anxiety, Stress, Perception of Low Back Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181011041308N1
Registration date:2018-11-26, 1397/09/05
Registration timing:retrospective
Last update:2018-11-26, 1397/09/05
Update count:0
Registration date
2018-11-26, 1397/09/05
Registrant information
Name
Mahmoud Reza Alebouyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 6136
Email address
alebuieh.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-01-04, 1396/10/14
Actual recruitment start date
2018-01-06, 1396/10/16
Actual recruitment end date
2018-01-11, 1396/10/21
Trial completion date
2018-02-16, 1396/11/27
Scientific title
The effectiveness of Mindfulness-Based Stress Reduction (MBSR) on the rate of depression, anxiety, stress, and the perception of low back pain after childbirth
Public title
The effectiveness of Mindfulness therapy on the perception of pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having back pain after three months from the childbirth
Having chronic back pain due to childbirth
Exclusion criteria:
Having mental illness
Using other treatments related to back pain including psychological or physical
Use of pain killer medications
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, random allocation rule which is a limited randomization method was used. Thus, after determining a sample size of 40 people, their names were put in a lottery vase randomly. Then, the first 20 names which were taken out randomly were dedicated to the experimental group. The remaining names were dedicated to the control group.
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
Scientific Committee on Ethics in Biomedical Research, Tehran Azad University of Medical Sciences
Street address
Tehran-Ghods Town (West), Iran's Sims Street-Headquarters of the Ministry of Health, Medical Education and Training, Block A, Thirteenth Class
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2017-12-19, 1396/09/28
Ethics committee reference number
IR.IAU.TMU.REC.1396.217
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Perception of pain
Timepoint
Before intervention, after intervention, and one month after intervention
Method of measurement
Oswestry Disability Index (ODI)
2
Description
Depression‚ Anxiety‚ Stress
Timepoint
Before intervention, after intervention, and one month after intervention
Method of measurement
Depression‚ Anxiety‚ Stress Scale (DASS)
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group: This group received the mindfulness program during eight weeks, one 120-minute session each week. A brief explanation of the sessions is given as follows. First session: defining the general guideline considering the privacy and confidentiality of the private life of the people, asking people to introduce themselves to each other, training the body verification, homework, discussion and scheduling weekly meetings, distribution of notes, handouts and CDs. Second session: Training body relaxation for the 14 group of muscles including forearm, arm, calf, thighs, abdomen, chest, shoulders, neck, lips, eyes, and forehead. Third session: Training body relaxation for the 6 group of muscles including hands and arms, legs and thighs, abdomen and chest, forehead and lips, and the homework for the body relaxation. Fourth session: Introduction to the method for the breath mindfulness , training the technique of inhale and exhale with relaxation and and without thinking about other issues, training the technique for watching the breath, and the homework for the breath mindfulness before the sleep. Fifth session: Training the technique for the attention to the body movements during breath, concentration on the body parts and their movements and the search for physical senses, and homework for the eating mindfulness. Sixth session: Training to concentrate on the mind, positive and negative thoughts, pleasant and unpleasant thoughts, letting the positive and negative thoughts to enter the mind and easily moving them out of the mind without making judgment and paying deep attention to them. Seventh session: a 40-minute sitting meditation, review of the homeworks, exercising the observation of the relation between activity and the behavior. Eighth session: review of the past sessions, conclusion, and questions and answers.
Category
Other
2
Description
Control group: This group did not receive the mindfulness program and they were monitored to avoid using psychological and physical treatments or pain killers during the eight weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sa'adat Abad Community Health Center
Full name of responsible person
Farzaneh Farahmand
Street address
Near the prison shop, the front of Evin prison, Street martyr Kachuei, Saadat Abad,
City
Tehran
Province
Tehran
Postal code
1558738816
Phone
+98 21 2211 5750
Email
sghc@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Babakhani
Street address
Rudehen shahrake pona
City
Roudehen
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5015
Email
info@riau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Narges Babakhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Roudehen, Academic Complex
City
Roudehen
Province
Tehran
Postal code
397318898
Phone
+98 21 2291 5385
Email
babakhani@riau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Committee of Islamic Azad University of Roudehen
Full name of responsible person
Narges Babakhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Roudehen, Academic Complex
City
Roudehen
Province
Tehran
Postal code
3973188981
Phone
+98 21 2291 5385
Email
babakhani@riau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Research Committee of Islamic Azad University of Roudehen
Full name of responsible person
Elaheh Sobhani
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Roudehen, Academic Complex
City
Roudehen
Province
Tehran
Postal code
3793188981
Phone
+98 21 2282 2976
Email
Elahe_so61@yahoo.com
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only pre-test, post-test and follow-up data are available.
When the data will become available and for how long
The time of access is 6 months after the publication of the article.
To whom data/document is available
Data is only available for academic researchers.
Under which criteria data/document could be used
It can be submitted to the reviewers or critics of the article.
Applicants must be academic members of a university.
From where data/document is obtainable
Islamic Azad University of Roodehen, Tehran, Dr. Narges babakhani, Address Email: babakhani@riau.ac.ir
What processes are involved for a request to access data/document
By sending an email to Dr Babakhani and then confirming it, you can receive the data and it takes less than two weeks.