The Effect of Self Acupressure in Patients With Multiple Sclerosis

October 10, 2024 updated by: Gülden Atan, Yuzuncu Yıl University

The Effect of Self Acupressure on Fatigue and Sleep Quality in Patients With Multiple Sclerosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In addition to pharmacological methods, patients with MS also use non-pharmacological methods in the treatment of the symptoms they experience. Acupuncture, acupressure, aquatherapy, reflexology and aromatherapy are also complementary and integrated methods frequently used in 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 (NIC), and is a method that increases the independent functions of the nurse and improves patient-nurse interaction. In addition, it is reported that acupressure, which is used in symptom control, should be used in care plans by nurses because it is one of the integrated methods. Acupressure, one of the integrated treatment methods used for many years, can be applied to increase sleep quality and reduce fatigue levels. Acupressure is a massage technique based on the principle of applying pressure to specific points on the body using hands, fingers and stimulator tools. It has been determined that acupressure, which is reported to be applied safely by nurses in the literature, is effective in controlling fatigue, pain, sleep quality, depression, anxiety, quality of life and stress levels of patients with MS. Therefore, nurses should be able to apply integrated methods in the management of symptoms experienced by patients with MS in cooperation with other members of the healthcare team and inform patients about these methods. It is believed that the results of the study to be conducted on this subject will contribute to nursing interventions in the symptom management of MS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey
        • Yuzuncu Yıl University , Faculty of health science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: acupressure
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
The patients in the experimental group received acupressure application for a total of 8 sessions, 2 sessions per week.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue Severity Scale
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yıl University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gülden Atan, PHD, Faculty of health science, Yuzuncu Yıl University , Van, TURKEY.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS-GULDEN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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