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The effectiveness of hypnosis-based mindfulness therapy on psychological aspects and severity of headache in patients with chronic migraine

Protocol summary

Study aim
The aim of this study is to evaluate the effectiveness of hypnosis-based Mindfulness therapy, on the psychological aspects of headache including psychological inflexibility, pain acceptance, pain anxiety, pain catastrophizing, mindfulness, self-compassion, emotion regulation strategies, psychological distress, and headache disability, and the severity of headache in patients with chronic migraine.
Design
A randomized clinical trial with a parallel control group, single blind, on 38 patients. Excel software rand function was used for randomization.
Settings and conduct
Therapeutic intervention will be performed in 8 one-hour individual sessions according to the Elkins protocol in the clinical psychology of Taleghani Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having chronic migraine headaches according to the International Headache Committee (IHS) and the beta version of the Third International Classification of Headache Disorders (ICHD-3 beta); Having informed consent to participate in the research and signing the informed consent form; Age range between 18 and 50 years; At least a diploma degree; Female gender. Exclusion Criteria: Having other chronic pain problems; Have a history of psychotherapy in the last 6 months; Participate in another psychological intervention simultaneously; Recent drugs abuse; Existence of diagnostic indicators or history of borderline personality disorder, psychosis, or schizophrenia due to interference with hypnosis; History of epileptic seizures or facial nerve pain.
Intervention groups
Intervention group: Mindful Hypnotherapy. Control group: routine medical treatment.
Main outcome variables
Psychological inflexibility, pain acceptance, pain anxiety, pain catastrophizing, mindfulness, self-compassion, emotion regulation strategies, psychological distress, headache disability, headache severity.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201009048974N2
Registration date: 2022-01-21, 1400/11/01
Registration timing: retrospective

Last update: 2022-01-21, 1400/11/01
Update count: 0
Registration date
2022-01-21, 1400/11/01
Registrant information
Name
Maryam Bakhtiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
maryam_bakhtiyari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of hypnosis-based mindfulness therapy on psychological aspects and severity of headache in patients with chronic migraine
Public title
The effectiveness of Mindful Hypnotherapy on psychological aspects and severity of headache in patients with chronic migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having chronic migraine headaches according to the International Headache Committee (IHS) and the beta version of the Third International Classification of Headache Disorders (ICHD-3 beta) Having informed consent to participate in the research and signing the informed consent form Age range between 18 and 50 years At least a diploma degree Female gender
Exclusion criteria:
Having other chronic pain problems Have a history of psychotherapy in the last 6 months Participate in another psychological intervention simultaneously Recent drugs abuse Existence of diagnostic indicators or history of borderline personality disorder, psychosis or schizophrenia due to interference with hypnosis History of epileptic seizures or facial nerve pain
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple randomization method. the random unit is individuals. 38 patients with chronic migraine will be divided into intervention and control groups by Microsoft Excel software using Rand function. In this way, a table of random numbers will be prepared and the Randbetween function will be created and the patients will be divided into two groups of 19 people respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor in data collection after the intervention and the data analyst will be unaware of the objectives of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran, Ghods Town (West), between South Flamek and Zarafshan, Iran TV St. - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
Tehran
Province
Tehran
Postal code
11111-11111
Approval date
2022-01-04, 1400/10/14
Ethics committee reference number
IR.SBMU.MSP.REC.1400.651

Health conditions studied

1

Description of health condition studied
Chronic migraine headache
ICD-10 code
G43.701
ICD-10 code description
Chronic migraine without aura, not intractable, with status migrainosus

Primary outcomes

1

Description
psychological inflexibility
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Psychological Inflexibility Pain Scale (PIPS)

2

Description
Pain Acceptance
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Pain acceptance questionnaire (CPAQ)

3

Description
Pain Anxiety
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Pain Anxiety Symptoms Scale (PASS-20)

4

Description
Pain Catastrophizing
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Pain Catastrophizing Scale (PCS)

5

Description
Mindfulness
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Five Facet Mindfulness Questionnaire (FFMQ)

6

Description
Self-Compassion
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Self-Compassion Scale (SCS)

7

Description
Emotion Regulation
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Emotion Regulation Strategies Questionnaire (ERQ)

8

Description
Psychological Distress
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Kessler Psychological Distress Scale (K10)

9

Description
Headache related disability
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Headache related disability questionnaire (HDI)

10

Description
headache intensity
Timepoint
In the per-intervention and post-intervention stages for 2 months
Method of measurement
Visual Analogue Scale (VAS), McGill Pain Questionnaire (MPQ), Blanchard headache diary

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mindful Hypnotherapy. This treatment will be performed in 8 one-hour individual sessions according to the Elkins protocol.
Category
Treatment - Other

2

Description
Control group: At first, the control group does not receive any intervention and only the results of their evaluations, which are done by the relevant questionnaires, will be compared with the intervention group. At the end of the study, for all members of the control group, Mindful hypnotherapy intervention will be performed in 8 one-hour individual sessions according to the Elkins protocol.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaie Tajrish hospitals
Full name of responsible person
Hassan Khazraee
Street address
Tajrish Sq, Tajrish Hospital
City
Tehran
Province
Tehran
Postal code
11111-11111
Phone
+98 912 957 6671
Email
hassankhazraee@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahid Beheshti University of Medical Science
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2243 9982
Email
taleghani@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hassan Khazraee
Position
PHD student of Clinical psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
arabi St, Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
11111-11111
Phone
+98 21 2293 5548
Email
hassankhazraee@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hassan Khazraee
Position
PHD student of Clinical psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Arabi St, Taleghani hospital
City
Tehran
Province
Tehran
Postal code
11111-11111
Phone
+98 21 2293 5548
Email
hassankhazraee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hassan Khazraee
Position
PHD student of Clinical psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
arabi St, Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
11111-11111
Phone
+98 21 2293 5548
Email
hassankhazraee@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Participants' data will be shared in the SPSS file using by code of participants (not using first and last name)
When the data will become available and for how long
Access to the data will be after the articles are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Request from the journals where the articles related to this research intend to be published.
From where data/document is obtainable
By receiving confirmation via email to the main executor or executors of the project
What processes are involved for a request to access data/document
Send an email to the main executor or other executors of the project and receive written confirmation through them
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