Protocol summary

Summary
There are many researches on relationship between stress and depression with migraine; however, much experimental evidence is needed to make such a view more validated. The aim of this study was experimental investigation of mood induction and stress on pain intensity in migraine patients. Patients were included in the study if they were: aged between 18 and 65, had a formal diagnosis of migraine by a neurologist, had a complaint of migraine for six months or longer and had a high school certificate (12 years of formal education or higher). Patients excluded from the study were those with severe depression or anxiety, severe daily headache and pregnancy. The study population was all patients suffering migraine in Tehran. For this purpose, 60 migraine patients were recruited from Baqiyatallah Hospital in Tehran-Iran in 2011-2012 years, and were randomly assigned into one of three groups: negative mood induced group, positive mood induced group and control group. The following instruments and measures were used in this study: Mood induction by presenting different types of films, and a computerized cognitive task to elicit pain. The pain intensity was measured in three steps (at baseline, after computerized task, and after showing film). All eligible participants were asked to complete baseline self-report measure of pain intensity prior to receiving pain and mood induction. Following this, computerized task of cognitive exhaustion to elicit pain was used, and after this stage, the mood induction procedure by showing a film was applied.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014052417813N1
Registration date: 2014-07-09, 1393/04/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-09, 1393/04/18
Registrant information
Name
Zahra Goli
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 8832 9220
Email address
golim.psych@gmail.com
Recruitment status
Recruitment complete
Funding source
individual
Expected recruitment start date
2011-09-01, 1390/06/10
Expected recruitment end date
2012-06-01, 1391/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The experimental effects of mood and stress induction on the pain intensity in migraine patients
Public title
effect of mood and stress on pain intensity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged between 18 and 65; formal diagnosis of migraine by a neurologist; experience of migraine for six months or longer; 12 years of formal education or higher Exclusion criteria: severe depression or anxiety; severe daily headache; pregnancy
Age
From 18 years old to 65 years old
Gender
Female
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
-Kharazmi University
Street address
-Faculty of Psychology, Kharazmi University, Daneshgah Sq., Shahid Beheshti Str., Karaj, Iran
City
-Karaj
Postal code
-
Approval date
2010-04-21, 1389/02/01
Ethics committee reference number
-63/824

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura [classical migraine]

2

Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]

Primary outcomes

1

Description
Pain intensity
Timepoint
At baseline, after half an hour, after one hour
Method of measurement
Pain Numerical Rating Scale

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Control group: (1) implementation of computerized cognitive exhaustion task in order to stress and pain induction, (2) break time for 7 minutes, (3) to read a neutral magazine for 12 minutes.
Category
Other

2

Description
Elated group: (1) implementation of computerized cognitive exhaustion task in order to stress and pain induction, (2) break time for 7 minutes, (3) showing a happy film clip for 12 minutes in order to elated mood induction.
Category
Other

3

Description
Depressed group: (1) implementation of computerized cognitive exhaustion task in order to stress and pain induction, (2) break time for 7 minutes, (3) showing a sad film clip for 12 minutes in order to depressed mood induction.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Baqiyatallah Hospital of Tehran
Full name of responsible person
Zahra Goli
Street address
46, Navvab Safavi Ave., Amirkabir Str., kashan
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Hosein Kachuee
Street address
Baqiyatallah Hospital, Molla Sadra Str, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Kharazmi University
Full name of responsible person
Goli Zahra
Position
M.A of Clinical Psychology
Other areas of specialty/work
Street address
46, Navvab Safavi Ave., Amirkabir Str., Kashan
City
Kashan
Postal code
Phone
+98 36 1530 8822
Fax
Email
golim.psych@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
kharazmi University
Full name of responsible person
Goli Zahra
Position
M.A of Clinical Psychology
Other areas of specialty/work
Street address
46, Navvab Safavi Ave., Amirkabir Str., Kashan
City
Kashan
Postal code
Phone
+98 36 1530 8822
Fax
Email
golim.psych@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Goli Zahra
Position
M.A of Clinical Psychology
Other areas of specialty/work
Street address
46, Navvab Safavi Ave., Amirkabir Str., Kashan
City
Kashan
Postal code
Phone
00
Fax
Email
golim.psych@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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