Protocol summary

Study aim
Determining the effect of desensitization through eye movements and reprocessing on movement phobia (kinesiophobia) and performing daily activities in the elderly with musculoskeletal pain.
Design
44 eligible elderly people will be divided into two equal groups by simple randomization method and the intervention will be done on one of the groups based on random selection.
Settings and conduct
In the elderly have a kinesiophobia with musculoskeletal pain referring to the outpatient clinic of Dr. Abbasi in Rafsanjan, the EMDR intervention group is performed by the researcher individually.
Participants/Inclusion and exclusion criteria
Entry requirements include: being over 60 years old. Not having severe hearing and vision problems. Obtaining a score higher than 18 from the TSK questionnaire. No addiction and use of neuropsychiatric drugs. Having musculoskeletal pain for 6 months. Obtain informed consent. Not having diseases like Parkinson's and Korea. No bereavement and acute mental problems in the last 6 months. Exit criteria include: unwillingness to continue cooperation. Conducting other psychotherapeutic interventions such as CBT on kinesiophobia. The use of psychotherapeutic drugs is effective against kinesiophobia (such as antidepressants and anti-anxiety drugs).
Intervention groups
First, the participants will complete the questionnaires of fear of movement and daily activities of life, for the intervention group EMDR sessions will be conducted individually for 8 weeks and 3 sessions of 45 to 60 minutes each week (up to a maximum of 90 minutes) by the researcher for each elderly person. and there will be no intervention for the control group. Then, at the end and one month after the end of the intervention, the aforementioned questionnaires will be completed again by the participants.
Main outcome variables
kinesiophobia, Activities of Daily Living

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150519022320N31
Registration date: 2023-08-09, 1402/05/18
Registration timing: prospective

Last update: 2023-08-09, 1402/05/18
Update count: 0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Eye Movement Desensitization and Reprocessing (EMDR) on kinesiophobia and ADL in elderly with musculoskeletal pain referring to outpatient clinicin Rafsanjan city in 2023.
Public title
The effect of Eye Movement Desensitization and Reprocessing (EMDR) on kinesiophobia and ADL in elderly with musculoskeletal pain referring to outpatient clinicin Rafsanjan city in 2023.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 60 years old Not having severe hearing and vision problems Obtaining a score higher than 18 from the TSK questionnaire No addiction and use of neuropsychiatric drugs Having musculoskeletal pain for 6 months Obtain informed consent Not having diseases like Parkinson's and Korea No bereavement and acute mental problems in the last 6 months
Exclusion criteria:
Lack of informed consent Non-cooperation based on the programs taught Taking psychotherapeutic drugs effective on kinesiophobia (such as antidepressants and anti-anxiety drugs) Conducting other psychotherapeutic interventions such as CBT on kinesiophobia
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying the elderly who meet the inclusion criteria and listing them, they will be divided into 2 groups of 22 people, the intervention group and the control group, using a simple random division method using a random number table. People will be divided into two groups based on the random number table. 22 people A and B will be divided and finally two groups A and B will be placed in test and control groups based on lottery.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Rafsanjan University of Medical Sciences
Street address
School of Nursing and Midwifery, Nurse avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2023-08-07, 1402/05/16
Ethics committee reference number
IR.RUMS.REC.1402.063

Health conditions studied

1

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

2

Description of health condition studied
Activities of Daily Living
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Kinesiophobia of the elderly with musculoskeletal pain
Timepoint
All participants will complete the Tampa Fear of Movement Questionnaire (TSK) before and after the intervention and one month after the end of the intervention.
Method of measurement
Fear of Movement Tampa Questionnaire (TSK)

2

Description
Activities of Daily Living in the elderly with musculoskeletal pain
Timepoint
All participants will complete ADL and IADL questionnaires before and after the intervention and one month after the end of the intervention.
Method of measurement
ADL and IADL questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
The researcher will start the work after stating the goals and method of the study and obtaining the consent of the people to participate in the study. Participants will complete questionnaires of fear of movement and activities of daily living, for the eye movement desensitization and reprocessing (EMDR) intervention group in eight steps; (1. history taking and treatment design 2. preparation 3. examination and evaluation 4. desensitization 5. operation 6. physical examination 7. termination or closure 8. re-evaluation) is done. EMDR sessions will be conducted individually and face-to-face for 8 weeks and 3 sessions of 45 to 60 minutes each week (up to a maximum of 90 minutes) by the researcher (the first session by the therapist and under his supervision) for each elderly person. In this intervention, the patient creates scenes of fear of movement in his mind, and during EMDR movements, he follows the researcher's finger with eye movements to finally get rid of the confusion caused by movement phobia. Each finger movement takes approximately one to two seconds. Each finger movement cycle is 20 seconds or more. Then, at the end and one month after the end of the intervention, the aforementioned questionnaires will be completed again by the participants.
Category
Treatment - Other

2

Description
Control group: During the study period, there will be no intervention in the control group and the questionnaires will be completed by the participants.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Outpatient rheumatology clinic of Rafsanjan city
Full name of responsible person
Dr. Ali Ravari
Street address
Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Reza Vazirinejad
Street address
Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3131 5075
Email
rvazirinejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Ravari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Ravari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Ravari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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