Multiple SclerosisNCT06600971
The Effect of Self Acupressure in Patients With Multiple Sclerosis
A study testing acupressure application in people with Multiple Sclerosis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- acupressure application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2024to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yıl University , Faculty of health science
Van
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- acupressure application
- Keywords
- Multiple Sclerosis, Acupressure, Fatigue, Sleep Quality
- Medical subject headings
- Multiple Sclerosis, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure applicationOther
The patients in the experimental group received acupressure application for a total of 8 sessions, 2 sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Mar 2024
- Primary completion18 Jul 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention and control groups were selected by drawing lots
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülden Atan, Yuzuncu Yil University
- Investigators
- Gülden Atan, PHD, Principal investigator, Faculty of health science, Yuzuncu Yıl University , Van, TURKEY.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600971
- Sponsor's protocol ID
- MS-GULDEN
- Status last verified
- Oct 2024
- First submitted
- 10 Sep 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self Acupressure on Fatigue and Sleep Quality in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06600971
- Acronym / sponsor ID
- MS-GULDEN
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Acupressure, Fatigue, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The intervention and control groups were selected by drawing lots
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Other: acupressure applicationThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- • Patients with nerve, soft tissue, vascular disease infections in their extremities, who have undergone surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressure applicationThe patients in the experimental group received acupressure application for a total of 8 sessions, 2 sessions per week. | Other | acupressure |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülden Atan, PHD principal investigator
Faculty of health science, Yuzuncu Yıl University , Van, TURKEY.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure application in people with Multiple Sclerosis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.