The Effectiveness of Mindfulness‐Based Stress Reduction (MBSR) Bibliotherapy on Stress, Depression, Individual Performance, Pain severity & Mindfulness in Outpatients with Migraine
The aim of this study was to Evaluating the Effectiveness of Mindfulness Based Stress Reduction (MBSR) bibliotherapy methods on women with migraines.
Design
Random assignment to intervention and control groups
Settings and conduct
women with migraines headache referring to headache clinic in Baqiyatallah Hospital in Tehran from March 2017 to May 2017.
Participants/Inclusion and exclusion criteria
All women with migraines Headache referring to the headache clinic of Baqiyatallah hospital in Tehran from March 2017 to May 2017.
Diagnosis of migraines by a specialist doctor based on the International Association of Headache Criteria
Age between 20 to 50 years
Level of education: minimum diploma
Internet access and social networks
Exclusion criteria:
Severe mental disorder
Failure to respond to therapist follow up for two consecutive weeks
Intervention groups
Among them, 30 subjects (including experimental and control groups) were selected by objective sampling method and randomly placed two groups. The experimental group, in addition to the current drug therapy, was treated in a correspondence course for 8 sessions of stress-reduction mindfulness. The control group received only medication.
Main outcome variables
Intensity of pain
Frequency of headaches
Disabling
Distressing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170118032033N4
Registration date:2018-06-30, 1397/04/09
Registration timing:registered_while_recruiting
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Zohreh Naderi
Name of organization / entity
baqiyatallah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3531
Email address
rsr.z45naderi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Mindfulness‐Based Stress Reduction (MBSR) Bibliotherapy on Stress, Depression, Individual Performance, Pain severity & Mindfulness in Outpatients with Migraine
Public title
Mindfulness Bibliotherapy for Female Outpatients with Migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of migraines by a specialist doctor based on the International Association of Headache Criteria
Age between 20 to 50 years
Level of education: minimum diploma
Internet access and social networks
Exclusion criteria:
Severe mental disorder
Failure to respond to the therapist for two weeks in a row
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
30 subjects (including the experimental and control group) were selected by objective sampling method and randomly placed in two groups.
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 Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Mulla Sadra Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2017-04-30, 1396/02/10
Ethics committee reference number
IR.BMSU.REC.1396.374
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine with aura [classical migraine]
Primary outcomes
1
Description
Pain severity
Timepoint
Before and after the intervention
Method of measurement
Migraine Disability Assessment Scale (MIDAS)
2
Description
Frequency of headaches
Timepoint
Before the intervention and after the end of the eight sessions of educational-medical correspondence of mindfulness
Method of measurement
Migraine Disability Assessment Scale (MIDAS)
3
Description
Disability
Timepoint
Before the intervention and after the end of the eight sessions of educational-medical correspondence of mindfulness
Method of measurement
Migraine Disability Assessment Scale (MIDAS)
4
Description
Distress
Timepoint
Before the intervention and after the end of the eight sessions of educational-medical correspondence of mindfulness
Method of measurement
Depression Anxiety Stress Scale (DASS-21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Received Medical Treatment As Usual, in addition followed by a course of 8 sessions of Mindfulness Based Stress Reduction bibliotherapy.
Category
Treatment - Other
2
Description
Control group: The control group received only the Medical Treatment As Usual (MTAU) for migrain.