Protocol summary

Study aim
The aim of this study was to investigate the effectiveness of self-healing training in pain-related anxiety and the severity of perceived pain in patients suffering from migraine.
Design
In this research a total number of 60 patients were selected as sample according to convenience sampling and based on inclusion and exclusion criteria. They were divided into two experimental and control groups (n=30 per group) through random assignment.
Settings and conduct
Fourteen sessions of self-healing training (once a week and in 90 minutes)
Participants/Inclusion and exclusion criteria
In this research a total number of 60 patients were selected as sample according to convenience sampling and based on inclusion and exclusion criteria. They were divided into two experimental and control groups (n=30 per group) through random assignment. The inclusion criteria were: having the symptoms of migraine for 3 years confirmed through the clinical interview by the clinical specialist, being at the age group between 20 to 40, not having received simultaneous psychological therapies, having finished at least guidance school, and filling out the consent form indicating the knowingly participation. The exclusion criteria were non-cooperation and avoiding doing the presented tasks in sessions, being absent from more than two sessions, suffering from acute or chronic psychological disorders
Intervention groups
The experimental group received fourteen sessions of self-healing training (once a week and in 90 minutes).
Main outcome variables
Pain-Related Anxiety and the Severity of Perceived Pain in Patients with Migraine

General information

Reason for update
Acronym
Self-Healing
IRCT registration information
IRCT registration number: IRCT20200529047592N1
Registration date: 2020-06-05, 1399/03/16
Registration timing: retrospective

Last update: 2020-06-05, 1399/03/16
Update count: 0
Registration date
2020-06-05, 1399/03/16
Registrant information
Name
Zohreh Latifi
Name of organization / entity
Payame Noor University
Country
Iran (Islamic Republic of)
Phone
+98 31 3352 1023
Email address
latifizh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Self-Healing Training (the Healing Codes) on Pain-Related Anxiety and the Severity of Perceived Pain in Patients with Migraine
Public title
The Effectiveness of Self-Healing Training in Patients with Migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having the symptoms of migraine for 3 years confirmed through the clinical interview Being at the age group between 20 to 40 Not having received simultaneous psychological therapies Having finished at least guidance school
Exclusion criteria:
Non-cooperation and avoiding doing the presented tasks in sessions Being absent from more than two sessions Suffering from acute or chronic psychological disorders
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research a total number of 60 patients were selected as sample according to convenience sampling and based on inclusion and exclusion criteria. They were divided into two experimental and control groups (n=30 per group) through random assignment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
دانشگاه پیام نور
Street address
Artesh Boulevard, Nakhl Street
City
Tehran
Province
Tehran
Postal code
46970-19395
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.PNU.REC.1398.073

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Training based on therapeutic approach of self-healing had a significant effect on the pain related anxiety and the dimension of severity of perceived pain by the participants of experimental group in post-test and follow-up.
Timepoint
The follow-up was performed after 60 days
Method of measurement
Post-test and follow-up

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: ُelf-healing training
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Shahid Sadoughi Hospital
Full name of responsible person
Nasrin Shahbazi
Street address
Isfahan Shahid Sadoughi Hospital
City
Isfahan
Province
Isfehan
Postal code
3132912500
Phone
+98 31 3291 2500
Email
latifizohre@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payame Noor University
Full name of responsible person
Zohreh Latifi
Street address
Artesh Boulevard, Nakhl Street
City
Tehran
Province
Tehran
Postal code
46970-19395
Phone
+98 21 2332 0000
Email
info@pnu.ac.ir
Web page address
http://pnu.ac.ir/Portal/Home/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Zohreh Latifi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ashrafi Isfahani Blvd, Nabavi Manesh St.
City
Isfahan
Province
Isfehan
Postal code
8139567111
Phone
+98 31 3352 1023
Email
latifizh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Zohreh Latifi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ashrafi Isfahani Blvd, Nabavi Manesh St.
City
Isfahan
Province
Isfehan
Postal code
8139567111
Phone
+98 31 3352 1023
Email
latifizh@gmail.com
Web page address
https://scholar.google.com/citations?user=cUa_P3kAAAAJ&hl=en

Person responsible for updating data

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Zohreh Latifi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ashrafi Isfahani Blvd, Nabavi Manesh St.
City
Isfahan
Province
Isfehan
Postal code
8139567111
Phone
+98 31 3352 1023
Email
latifizh@gmail.com
Web page address
https://scholar.google.com/citations?user=cUa_P3kAAAAJ&hl=en

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data is provided to organizations and researchers only at the official request.
When the data will become available and for how long
The data is provided to organizations and researchers only at the official request.
To whom data/document is available
The data is provided to organizations and researchers only at the official request.
Under which criteria data/document could be used
The data is provided to organizations and researchers only at the official request.
From where data/document is obtainable
The data is provided to organizations and researchers only at the official request.
What processes are involved for a request to access data/document
The data is provided to organizations and researchers only at the official request.
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