NCT06600971

Brief Summary

Patients with MS use non-pharmacological methods as well as pharmacological methods in the treatment of their symptoms. Acupuncture, acupressure, aquatherapy, reflexology and aromatherapy are also complementary and integrated methods frequently used in patients with MS. Integrated methods, which have an important place in independent nursing practices, have been preferred in nursing practices in recent years due to their safety, ease of application and minimal side effects. In addition, acupressure application is included in the Nursing Interventions Classification, and is a method that increases the independent functions of the nurse and improves patient-nurse interaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2024

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

March 18, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

September 10, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

Multiple SclerosisAcupressureFatigueSleep Quality

Outcome Measures

Primary Outcomes (2)

  • Fatigue Severity Scale

    The scale is a Likert type with 9 questions, and each question is rated from 1 (strongly disagree) to 7 (strongly agree). The total score varies between 9-63, with total scores of 27 and above indicating fatigue.

    4 weeks

  • Richard-Campbell Sleep Scale

    The scale consists of 6 items. The items measure the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time it takes to stay awake when you wake up, the quality of sleep, and the noise level in the environment. A score of "0-25" indicates "very bad sleep", and a score of "76-100" indicates "very good sleep". While the total score of the scale is calculated, the scores from the 5 items are added up, and the 6th item is not included in the total score evaluation. The minimum score from the scale is 0 and the maximum score is 100. An increase in the score from the scale indicates an increase in sleep quality.

    4 weeks

Study Arms (2)

acupressure

EXPERIMENTAL

The patients in the experimental group received acupressure application for a total of 8 sessions, 2 sessions per week. The first application was performed in a room in the polyclinic by a researcher with an acupressure application certificate. Immediately after the preparation phase, the researcher applied acupressure with the thumb in a certain order (Ht7-Ht7 and St36-St36) on each point to be pressed, in accordance with the acupressure application protocol, for a duration of 2 minutes. Verbal communication was maintained during the procedure to ensure the patient's relaxation. After the first application, the application was taught to the patient. In addition, the researcher established a WhatsApp group for regular follow-up of the patients in the experimental group, and the video recording of the acupressure was sent to the patients and they were asked to watch it.

Other: acupressure application

Control

NO INTERVENTION

During the study, it was explained to the control group that their fatigue and sleep quality levels would be monitored for four weeks without any intervention (other than routine treatment given by the physician). Patients in this group were asked to fill out the Fatigue Severity Scale and the Richard-Campbell Sleep Scale at the beginning and again in the 4th week.

Interventions

The patients in the experimental group received acupressure application for a total of 8 sessions, 2 sessions per week.

acupressure

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18-65,
  • Those who can read and write,
  • Those who can speak Turkish,
  • Patients diagnosed with multiple sclerosis,
  • Patients who do not have a neurological disease other than MS,
  • Those who volunteer to participate in our study,
  • Patients who are conscious and do not have a psychiatric health problem

You may not qualify if:

  • Patients with nerve, soft tissue, vascular disease infections in their extremities, who have undergone surgery,
  • Patients with bleeding problems, pacemaker or heart failure and a diagnosed condition, mass and flattening in the neck,
  • Patients with a diagnosis other than MS (such as subarachnoid hemorrhage, aneurysm, dementia, a psychiatric disease),
  • Patients who have had a hemorrhagic stroke,
  • Patients with malignancy,
  • Patients with vision and hearing problems,
  • Patients who do not volunteer to participate in our study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yıl University , Faculty of health science

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisFatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Gülden Atan, PHD

    Faculty of health science, Yuzuncu Yıl University , Van, TURKEY.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The information indicating that the patients included in the research sample were assigned to groups A and B according to the randomization table was placed in an opaque envelope. This envelope was kept by the neurology clinic secretariat. When the researcher went to the patient selected for acupressure application, he first applied a pre-test and then contacted the neurology clinic secretariat to learn which group the patient was in. In this way, the participants were blinded in terms of groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The intervention and control groups were selected by drawing lots
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

March 18, 2024

Primary Completion

July 18, 2024

Study Completion

September 3, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations