NCT04936555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

June 15, 2021

Last Update Submit

July 16, 2021

Conditions

Keywords

Self-AcupressureFunctional compositeQuality of life

Outcome Measures

Primary Outcomes (4)

  • 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.

    1. week

  • 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.

    4. week

  • 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.

    1.week

  • 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.

    4.week

Study Arms (2)

Self-Acupressure

EXPERIMENTAL

Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)

Other: Self-Acupressure

No Intervention

NO INTERVENTION

Control group Routine maintenance will be applied

Interventions

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.

Self-Acupressure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be able to communicate adequately
  • Not having psychiatric problems
  • Volunteering to participate in research

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Sabahattin Zain Universitiy

Istanbul, State, 34303, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Zülfünaz ÖZER, PhD

    Istanbul Sabahattin Zaim University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Self-Acupressure and control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an experimental study with pre-test and post-test control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD., Assistant Prof

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 23, 2021

Study Start

May 1, 2021

Primary Completion

June 1, 2021

Study Completion

July 15, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations