Protocol summary

Study aim
Determining the effect of mindfulness-based stress reduction method on resilience, quality of life and individual independence of spinal cord injury patients referred to medical centers affiliated to Kerman University of Medical Sciences.
Design
A randomized, double blinded, clinical trial design of 62 patients. Randomozation implemented by random function of Excel software.
Settings and conduct
Spinal cord injury patients referred to the rehabilitation centers of Kerman University of Medical Sciences were randomly divided into control and intervention groups. Patients, statistician, and the data control and safety monitoring committee are blinded to the group allocation.
Participants/Inclusion and exclusion criteria
Entry conditions: At least 12 weeks have passed since the onset of the disease and up to a maximum of 5 years ;these people are selected from the 18-year-old age group without any age limit ;The ability to communicate in Farsi ;Having a mobile phone with Android system; The patient has not participated in similar research in the last 3 months Non-entry conditions: Withdrawal of cooperation; Using psychotropic drugs, neuropsychiatric drugs and under the treatment of a psychiatrist; Previous experience of a similar intervention; Diseases associated with lesions in the studied sample
Intervention groups
In this study, the intervention of MBSR (Mindfulness-based stress reduction) is conducted in 90-minute face-to-face sessions weekly in groups of 5-16 people or individually for 8 weeks. Group sessions are held for patients who have the possibility to attend rehabilitation centers. Individual sessions in the researcher's presence are held at the patients' homes. The control group includes patients with the same conditions except they receive only routine medical care at home.
Main outcome variables
resilience; quality of life; individual independence

General information

Reason for update
Acronym
MBSR یا Mindfulness based stress reduction
IRCT registration information
IRCT registration number: IRCT20220813055673N1
Registration date: 2022-12-11, 1401/09/20
Registration timing: prospective

Last update: 2022-12-11, 1401/09/20
Update count: 0
Registration date
2022-12-11, 1401/09/20
Registrant information
Name
Reyhane Sarabandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3244 1446
Email address
reyhanesarabandi1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of mindfulness with routine care on resilience ,quality of life and individual independence in patients with spinal cord injury
Public title
The effect of mindfulness on resilience ,quality of life and individual independence in patients with spinal cord injury
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least 12 weeks have passed since the onset of the disease and up to a maximum of 5 years They must have the ability to use a mobile phone, so these people are selected from the 18-year-old age group without any age limit The ability to communicate in Farsi Having a mobile phone with an Android system and media applications The patient has not participated in similar research such as cognitive therapy or psychotherapy in the last 3 months
Exclusion criteria:
Withdrawal of cooperation Using psychotropic drugs, neuropsychiatric drugs and under the treatment of a psychiatrist Previous experience of a similar intervention on the patient Diseases associated with lesions in the studied sample, such as cognitive disorders and physical diseases such as cardiovascular disorders, diabetes, etc.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
According to the availability of the list of patients referred to two support centers, the list will be given to the statistician. The statistician who is blinded to the allocation codes to the groups, divides the 62 people with the dropout rate, into either the control or intervention group which is provided by Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The list is provided to the statistician, and he assigns people to each of the control and intervention groups according to the number of participants, which is 62 people including the dropout, using Excel software and without knowing the allocation of codes to the groups. In this study, statisticians, Data Safety and Monitoring Committee and patients will be blinded to the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
No. 2, Ibn Sina Street, Deputy of research and technology Bldg.
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-11-13, 1401/08/22
Ethics committee reference number
IR.KMU.REC.1401.363

Health conditions studied

1

Description of health condition studied
spinal cord injury
ICD-10 code
S24.109S
ICD-10 code description
Unspecified injury at unspecified level of thoracic spinal cord, sequela

Primary outcomes

1

Description
The score of Conner & Davidson resilience Questionnaire
Timepoint
At the point of recruitment day, 8weeks and 1 month later
Method of measurement
Conner & Davidson Resilience questionnaire

2

Description
Spinal cord injury Quality of life
Timepoint
At the point of recruitment day, and 1 month later
Method of measurement
SCI QL23 (Spinal cord injury Quality of life questionnaire)

3

Description
Spinal cord Independence
Timepoint
At the point of recruitment day, 8weeks and 1 month later
Method of measurement
SCIM III(Spinal cord Independence Measure)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this research, the intervention is Mindfulness based stress reduction in the form of 8 weekly face-to-face sessions of 90 minutes in the format of groups of 5-16 people for patients who have the possibility to attend treatment centers and to conduct the same sessions individually with the presence of the researcher at the patients' homes. In between the sessions, the researcher accompanies the patients online and provides them with the educational content of each session in the form of an audio file on the day of the training and reminds them of the daily repetition of the previous sessions.
Category
Rehabilitation

2

Description
Control group: 31 people who answer the questionnaires at all three specified times are included in the control group, which will not receive any special training except routine care at home during the intervention period. If there will be positive effect of the training on outcome measures, the intervention will be conducted for control group too.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation centers of Kerman University of Medical Sciences
Full name of responsible person
Reyhane Sarabandi
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3121 5220
Email
reyhanesarabandi1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza MalekpourAfshar
Street address
No. 2, Ibn Sina Street, Deputy of research and technology Bldg.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3815
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Omsalimeh Roudi Rashtabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5201
Email
fatroody@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Omsalimeh Roudi Rashtabadi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
fatroody@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Omsalimeh Roudi rashtabadi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
fatroody@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
Not applicable
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