Effectiveness of Mindfulness-Based Stress Reduction (MBSR) on pain intensity, anxiety, depression and quality of life of patients with chronic pain: Randomized Clinical Trials
This research was conducted with the purpose of effectiveness of Mindfulness-Based Stress Reduction (MBSR) on pain intensity, anxiety, depression and quality of life of patients with chronic pain: Randomized Clinical Trials.
Design
This study was a quasi-experimental study with a pretest, posttest and control group as a randomized clinical trial.
Settings and conduct
The statistical population of this study consisted of all patients with chronic pain referred to Imam Reza Army Hospital of Army of the Islamic Republic of Iran. Among these patients, 50 people who met the inclusion criteria and were willing to participate in the study were selected by convenience sampling and randomly assigned to the experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria the study were: the presence of at least one symptom of pain without any specific medical reason for at least 6 months, age between 18 and 60 years, the education level of at least middle school (8th grades). Exclusion criteria were: substance abuse and severe psychiatric problems such as psychosis.
Intervention groups
The experimental group received mindfulness-based stress reduction therapy (8 sessions for 8 week) and the control group did not receive any intervention.
Main outcome variables
pain intensity
anxiety
depression
quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171031037145N2
Registration date:2020-11-21, 1399/09/01
Registration timing:retrospective
Last update:2020-11-21, 1399/09/01
Update count:0
Registration date
2020-11-21, 1399/09/01
Registrant information
Name
Farshad Sheybani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2721
Email address
farshad.sheybani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-05-22, 1398/03/01
Trial completion date
2019-09-23, 1398/07/01
Scientific title
Effectiveness of Mindfulness-Based Stress Reduction (MBSR) on pain intensity, anxiety, depression and quality of life of patients with chronic pain: Randomized Clinical Trials
Public title
effect of stress reduction on chronic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
presence of at least one symptom of pain without any specific medical reason for at least 6 months
age between 18 and 60 years
the education level of at least middle school (8th grades)
Exclusion criteria:
substance abuse
severe psychiatric problems such as psychosis
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
47
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the announcement and invitation that was installed in Imam Reza hospital to participate in this research, the applicants called and expressed their desire to participate in the research. After the initial screening, patients were informed about the study and the form of informed consent were given to them. If the form is approved and signed, the therapist will conduct a structured clinical interview for DSM5 (SCID-5) and if they complied with the inclusion and exclusion criteria, the patient would enter the study as a research sample. Based on this, 50 patients were selected. After selecting patients and randomly assigning them to experimental and control groups. Patients were randomly assigned to two groups of 25 using 4 and 6 blocks with a ratio of 1: 1. Random allocation sequences of patients in both groups were performed using Randomizer software. Consecutive opaque numbered envelopes were used to conceal the allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer did not know the names of the study groups, and the groups were numbered.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
End of Etemadzadeh Street, West Fatemi Street , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-12-09, 1397/09/18
Ethics committee reference number
IR.AJAUMS.REC.1397.052
Health conditions studied
1
Description of health condition studied
Chronic Pain
ICD-10 code
R52.1
ICD-10 code description
Chronic intractable pain
Primary outcomes
1
Description
Anxiety: In this study, the severity of anxiety was measured using the Beck Anxiety Inventory
Timepoint
Before and after the intervention
Method of measurement
Beck Anxiety Inventory
2
Description
Quality of life: Quality of life is a person's perception of the state of life in the field of culture and value system in which she lives, and this concept is related to goals, expectations, criteria and important matters.
Timepoint
Before and after the intervention
Method of measurement
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
3
Description
Pain intensity: An unpleasant sensory and psychological experience associated with possible or actual tissue damage.
Timepoint
Before and after the intervention
Method of measurement
numeric pain rating scale
4
Description
Depression: Depression is a transient decrease or persistence of neuropsychological stress that manifests itself as a physical component (such as headache, fatigue, insomnia, constipation, hypotension) and a psychological component (such as feelings of hopelessness, sadness, inferiority).
Timepoint
Before and after the intervention
Method of measurement
Beck Depression Inventory-II (BDI-II)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The MBSR-based group intervention was based on the 8-session John Kabat-Zin approach, with a duration of 1.5 hours per session. The content of the MBSR 8 sessions was as follows: Session 1: Communication skills and conceptualization, the need to use mindfulness training, providing explanations about the auto-guidance system. Session 2: Review of last week's homework, body scan, meditation exercises, mindfulness-based breath training (MBRT).Session 3: Review of last week's homework, sitting meditation, practice review, three-minute breathing space training. Session 4: Review of last week's homework, a five-minute practice of "seeing or hearing," mindfulness-based breath training and body scan. Session 5: Review of last week's homework, breathing exercises, sitting meditation (awareness of breathing, body, sounds, and thoughts), explanations about stress and its relationship to pain, awareness of the effect of pleasant and unpleasant events on feelings, thoughts and body feelings. Session 6: Review of last week's homework, vigilant yoga, discussion of different views of thoughts or substitute thoughts, sitting meditation (Mindfulness of sounds and thoughts).Session 7: Review of last week's homework, sleep hygiene, repeating the homework of the previous sessions, and providing a list of fun activities. Session 8: Review of last week's homework, body scan, summing up the sessions, Check out and discuss about the programs and continuing the exercises for management of pain.
Category
Behavior
2
Description
Control group: The control group did not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Farshad Sheybani
Street address
End of Etemadzadeh Street, West Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Email
sheybani.f@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Alireza Dadashi
Street address
End of Etemadzadeh Street, West Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Email
sheybani.f@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Iran University of Medical Sciences
Full name of responsible person
Farshad Sheybani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
sheybani.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farshad Sheybani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
sheybani.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farshad Sheybani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
City
Tehra
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
sheybani.f@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD