1. Home
  2. Approved trials
  3. » فارسی

comparison between the effect of eye movement desensitization and reprocessing (EMDR) and guided imagery on the severity of insomnia and pain of rheumatoid arthritis patients

Protocol summary

Summary
The aim of study was to determine and comparison between the effect of eye movement desensitization and reprocessing (EMDR) and guided imagery on the severity of insomnia and pain of rheumatoid arthritis patients. Seventy five patients with rheumatoid arthritis will be divided randomly in three groups of Eye Movement Desensitization and Reprocessing (Group 1), guided imagery (Group 2) and control group (Group 3). Inclusion criteria for the study included: adult patients with rheumatoid arthritis, rheumatoid arthritis is diagnosed by a doctor, patients didn’t have a history of seizures, patients didn’t have a history of mental illness, patients didn’t have drug addiction, consent form must be completed by participants, patients shouldn’t have hearing or vision problems, having complete consciousness, to be literate. Exclusion criteria were: lack of motivation to continue working, relapse, migration and death, the bad memory of the forest and landscape. Population of the study consists of patients with rheumatoid arthritis were referred to Yasouj Mofateh martyr. Total sample size is 75 patients who will be divided in 3 groups of 25 people. Intervention group 1: Eye Movement Desensitization and Reprocessing (EMDR) will be done in six days. Intervention groups 2: guided Imagery will be done in six days and patients will be asked once daily for 35 minutes to listen to audio CDs. Group 3 will be the control group. Data will be collected two weeks before the intervention, two weeks after the start of interventions. Primary outcomes are the severity of insomnia and pain in rheumatoid arthritis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022926846N1
Registration date: 2016-05-02, 1395/02/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-02, 1395/02/13
Registrant information
Name
Nasrin GHanbarinia
Name of organization / entity
Yasuj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5141
Email address
nasrin.ghanbarinia@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between the effect of eye movement desensitization and reprocessing (EMDR) and guided imagery on the severity of insomnia and pain of rheumatoid arthritis patients
Public title
The effect of interventions based of psychological on the severity of insomnia and pain in rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for the study included: adult patients with rheumatoid arthritis, Rheumatoid arthritis is diagnosed by a doctor, Patients didn’t have a history of seizure, Patients didn’t have a history of mental illness,Patients didn’t have drug addiction, providing consent form , Patients shouldn’t have hearing or vision problems, having complete consciousness, to be literate. Exclusion criteria were: lack of motivation to continue participating, relapse, migration and death, the bad memory of the forest and landscape.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Seventy-five patients with rheumatoid arthritis will be divided into three groups by block

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran
City
Yasuj
Postal code
7591994799
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
Code of ethics:IR.YUMS.REC.1394.130

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified

Primary outcomes

1

Description
Insomnia Severity
Timepoint
Two weeks before the start of intervention - Two weeks afterthe start of intervention
Method of measurement
Insonia Severity Index(ISI)

2

Description
pain
Timepoint
Two weeks before the start of intervention - Two weeks afterthe start of intervention
Method of measurement
Rheumatoid Arthritis pain scale

Secondary outcomes

1

Description
havenot
Timepoint
havenot
Method of measurement
havenot

Intervention groups

1

Description
Interventions 1: Eye Movement Desensitization and Reprocessing (EMDR)group interventions will be done in an eight stage: Client History and Treatment Planning, Preparation, Assessment, Desensitization, Installation, Body Scan, Closure, Re-evaluation for 6 consecutive days by the researcher. Session lasts up to 90 minutes.
Category
Other

2

Description
Guided Imagery Group interventions will be done to visualize the landscape for patients in 6 consecutive sessions and of patients will be asked once daily for 35 minutes to listen to audio CDs.
Category
Other

3

Description
Control group: People in the control group will not receive any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology clinic of Shahid Mofateh
Full name of responsible person
Dr Ardashir Afrasiabifar
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Yasuj University of Medical Sciences
Full name of responsible person
Doctor Mehdi Akbartabar turi
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran
City
Yusuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Ardashir Afrasiabifar
Position
Ph.D of Medical Surgical Nursing- Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 5141
Fax
Email
afrasiabifar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Dr Ardeshir Afrasiabifar
Position
Ph.D of Medical Surgical Nursing- Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 5141
Fax
Email
afrasiabifar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Nasrin GHanbarinia
Position
MS student of Medical Surgical Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, St. Martyr Dr. Jalil, Yasuj, Iran
City
Yasuj
Postal code
7591994799
Phone
+98 47 3323 5141
Fax
Email
nasrin.ghanabarinia@yums.ac.ir nasringhanbari1393@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
Loading...