Efficacy of mindfulness based stress reduction on pain severity, mindful awareness, perceived stress and psychological health in patients with tension headache in Kashan
Mindfulness-based stress reduction (MBSR) is a new psychotherapy that appears to be effective in treating chronic pain and stress. In many disorders and illnesses there are symptoms of headache. This study evaluated efficacy of MBSR in treatment of tension headache. Methods: this study is a randomized clinical trial. Sixty patients with tension type headache according to the International Headache Classification Subcommittee were assigned in treatment as usual (TAU) or experimental group (MBSR) randomly. The MBSR group received eight weekly treatments. Any session was 120-min. The sessions were based on MBSR protocol. Diary scale for measuring headache, Mindful Attention Awareness Scale (MAAS), Brief Symptom Inventory (BSI) and Perceived Stress Scale (PSS) administered in pre and post treatment and at 3 months follow-up in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061618106N1
Registration date:2014-07-19, 1393/04/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-19, 1393/04/28
Registrant information
Name
Abdollah Omidi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5555 0021
Email address
omidi-a@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-06-19, 1391/03/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of mindfulness based stress reduction on pain severity, mindful awareness, perceived stress and psychological health in patients with tension headache in Kashan
Public title
Efficacy of mindfulness based stress reduction on pain severity, mindful awareness, perceived stress and psychological health in patients with tension headache
Purpose
Treatment
Inclusion/Exclusion criteria
Not receiving psychiatric medication and psychotherapy from 6 months up to the study of the experimental group; not receiving psychotherapy from 6 months up to the study in both experimental and control groups; no concurrent psychiatric problems.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
Approval date
2012-01-31, 1390/11/11
Ethics committee reference number
2615/11/11/90
Health conditions studied
1
Description of health condition studied
Tension headache
ICD-10 code
R51
ICD-10 code description
Headache
Primary outcomes
1
Description
pain
Timepoint
pre and post treatment and at 3 months follow-up
Method of measurement
Diary scale for measuring headache
Secondary outcomes
1
Description
mindful awareness
Timepoint
pre and post treatment and at 3 months follow-up
Method of measurement
Mindful Attention Awareness Scale
Intervention groups
1
Description
mindfulness based stress Reduction
The 8 weekly sessions followed the standard MBSR protocol as developed by Kabat-Zinn (1990). Each session was 150 min. The overall content of the sessions were: (a) Theoretical debates about relaxation, meditation, and body–mind connections; (b) train and practice of meditation and yoga both inside and outside the sessions during the day, (c) Resolve obstacles to successful training. In addition, a pamphlet consists of information related to each week’s instruction was provided for participants. Daily practice for them determined at least 40 min as homework.
Category
Lifestyle
2
Description
no psychotherapy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Medical University Clinics
Full name of responsible person
Abdollah Omidi
Street address
Kashan Medical University Clinics
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Omidi
Position
Assistant professor
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
omidi-a@kums.ac.irabomidi20@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Omidi
Position
Clinical psychologist, ph.D.
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
8715988141
Phone
+98 31 5555 0021
Fax
+98 31555550021
Email
omidi-a@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Zargar
Position
Assistant profesor
Other areas of specialty/work
Street address
kashan
City
kashan
Postal code
8715988141
Phone
+98 31 5555 0021
Fax
Email
fatemehzargar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)