The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Self-Acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Self-Acupressure, Functional composite, Quality of life
Eligibility Criteria
Inclusion Criteria:
- To be able to communicate adequately
- Not having psychiatric problems
- Volunteering to participate in research
Exclusion Criteria:
- None
Sites / Locations
- Istanbul Sabahattin Zain Universitiy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self-Acupressure
No Intervention
Arm Description
Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)
Control group Routine maintenance will be applied
Outcomes
Primary Outcome Measures
Multiple Sclerosis Functional Composite (MSFC)
The conventional MSFC battery (MSFC3), comprising the 25 foot timed walk test (TWT), 9-hole peg test (9HPT) and paced auditory serial addition test (PASAT) was performed according to standardised procedures, calculated according to the standard manual, and normalised to this cohort.
Multiple Sclerosis Functional Composite (MSFC)
The conventional MSFC battery (MSFC3), comprising the 25 foot timed walk test (TWT), 9-hole peg test (9HPT) and paced auditory serial addition test (PASAT) was performed according to standardised procedures, calculated according to the standard manual, and normalised to this cohort.
Multiple Sclerosis Quality of Life Scale-54
This scale was developed by Vickrey et al17 to evaluate the quality of life of patients with The scale was created by adding 18 MS-related items to SF-36 (short form). Physical and mental health composite scores are calculated, and higher scores indicate better quality of life. The Turkish version was developed by Tulek et al.
Multiple Sclerosis Quality of Life Scale-54
This scale was developed by Vickrey et al17 to evaluate the quality of life of patients with The scale was created by adding 18 MS-related items to SF-36 (short form). Physical and mental health composite scores are calculated, and higher scores indicate better quality of life. The Turkish version was developed by Tulek et al.
Secondary Outcome Measures
Full Information
NCT ID
NCT04936555
First Posted
June 15, 2021
Last Updated
July 16, 2021
Sponsor
Istanbul Sabahattin Zaim University
1. Study Identification
Unique Protocol Identification Number
NCT04936555
Brief Title
The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients
Official Title
The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Sabahattin Zaim University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is important to consider the functional composite and quality of life of patients with multiple sclerosis (MS) and to plan interventions for these problems.
Detailed Description
The application of Self-Acupressure helps in improving the functional composite and quality of life in Multiple Sclerosis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Self-Acupressure, Functional composite, Quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is an experimental study with pre-test and post-test control groups
Masking
Participant
Masking Description
Self-Acupressure and control group
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Acupressure
Arm Type
Experimental
Arm Description
Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Control group Routine maintenance will be applied
Intervention Type
Other
Intervention Name(s)
Self-Acupressure
Intervention Description
Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body.
Primary Outcome Measure Information:
Title
Multiple Sclerosis Functional Composite (MSFC)
Description
The conventional MSFC battery (MSFC3), comprising the 25 foot timed walk test (TWT), 9-hole peg test (9HPT) and paced auditory serial addition test (PASAT) was performed according to standardised procedures, calculated according to the standard manual, and normalised to this cohort.
Time Frame
1. week
Title
Multiple Sclerosis Functional Composite (MSFC)
Description
The conventional MSFC battery (MSFC3), comprising the 25 foot timed walk test (TWT), 9-hole peg test (9HPT) and paced auditory serial addition test (PASAT) was performed according to standardised procedures, calculated according to the standard manual, and normalised to this cohort.
Time Frame
4. week
Title
Multiple Sclerosis Quality of Life Scale-54
Description
This scale was developed by Vickrey et al17 to evaluate the quality of life of patients with The scale was created by adding 18 MS-related items to SF-36 (short form). Physical and mental health composite scores are calculated, and higher scores indicate better quality of life. The Turkish version was developed by Tulek et al.
Time Frame
1.week
Title
Multiple Sclerosis Quality of Life Scale-54
Description
This scale was developed by Vickrey et al17 to evaluate the quality of life of patients with The scale was created by adding 18 MS-related items to SF-36 (short form). Physical and mental health composite scores are calculated, and higher scores indicate better quality of life. The Turkish version was developed by Tulek et al.
Time Frame
4.week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
To be able to communicate adequately
Not having psychiatric problems
Volunteering to participate in research
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zülfünaz ÖZER, PhD
Organizational Affiliation
Istanbul Sabahattin Zaim University
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Sabahattin Zain Universitiy
City
Istanbul
State/Province
State
ZIP/Postal Code
34303
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25946938
Citation
Bastani F, Sobhani M, Emamzadeh Ghasemi HS. Effect of acupressure on fatigue in women with multiple sclerosis. Glob J Health Sci. 2015 Jan 26;7(4):375-81. doi: 10.5539/gjhs.v7n4p375.
Results Reference
result
Learn more about this trial
The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients
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