Nursing CariesNCT06634758
The Effect of the Human Care Model on Patients With Multiple Sclerosis
A study testing Nursing interventions based on the Watson Human Caring Model in people with Nursing Caries, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study was conducted to determine the effect of nursing care based on Watsons Human Caring Model on the quality of life of patients with MS. Materials and Methods: This randomized controlled study was conducted in Gülhane Training and Research Hospital, Neurology Department Outpatient Clinic between… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Nursing interventions based on the Watson Human Caring Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 28 Nov 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
- Having a score between 3-7 on the Expanded Disability Status Scale (EDSS) (Puz et al., 2018) divided the patients into two groups as EDSS\<3 and EDSS≥3 and reported that the frequency of comorbidity was high in patients with EDSS scores of 3 and above. For this reason, patients with EDSS scores below 3 were not included in the study. In addition, patients with EDSS scores above 7 are dependent on the caregiver/helper. Since the quality of life of dependent patients may be affected by the caregiver, patients with EDSS scores above 7 were not included in the study).
- Being between the ages of 18 and 65
- Being able to speak and understand Turkish, not having a speech-comprehension disorder
Who cannot join
- Having an attack during the research process
- Becoming pregnant during the research process
- Not being able to attend any or more of the four planned meetings in line with the care plan based on the Watson Human Care Model created for this research
- Wanting to leave the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi
Ankara, Keçiören, 06310
About this study
Official title: The Effect Of Nursing Care Based On Watson's Human Care Model On Quality Of Life Of Patients iıth Multıple Sclerosis
Purpose: This study was conducted to determine the effect of nursing care based on Watsons Human Caring Model on the quality of life of patients with MS.
Materials and Methods: This randomized controlled study was conducted in Gülhane Training and Research Hospital, Neurology Department Outpatient Clinic between January and November 2023.Patients were assigned to groups according to block randomization. The study was conducted with a total of 74 patients, 37 in the intervention and 37 in the control group. Four interviews were conducted with the patients, and a nursing care protocol based on the Watson Human Caring Model was applied. Patients in the control group underwent routine procedure. The "Multiple Sclerosis Symptom Management Booklet" and "Relaxation Exercises" educational materials used in the study were evaluated with the DISCERN measurement tool and the written materials evaluation form. Research data were obtained using the Data Collection Form, MS Quality of Life Scale, Watson Patient Satisfaction Form and Semi-Structured Interview Form.
Keywords: Watson Human Caring Model, MS, nursing care, quality of life.
Read the detailed description
Multiple Sclerosis (MS) is a chronic disease that usually affects young adults, progresses with attacks and remissions, causes widespread demyelinating lesions in the central nervous system, and can lead to functional limitations, disability, or a decrease in quality of life. It is reported that the number of individuals diagnosed with MS is approximately 58 thousand in our country and more than 2.9 million worldwide. This means that one person is diagnosed with MS every five minutes worldwide. According to the data of the Turkish Statistical Institute , MS ranks sixth among causes of death in 2022 with 3.5% and first among diseases that cause disability . According to TUİK data, 153 people died due to MS in 2021 and 138 people died in 2022 . As can be understood from the high rates of disability and death, MS is an important disease that critically affects people\'s lives and quality of life. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve and spinal cord; over time, it turns into a neurodegenerative disease associated with lack of neurotrophic support and neuron loss. Depending on the location and degree of degeneration of sensory and/or motor neurons during the course of the disease, various neurological disorders such as gait disturbance, loss of balance, muscle strength loss, fatigue, cognitive impairment and sensory loss occur alone or together. The physical, psychosocial and cognitive deficiencies caused by all these disorders and the chronic course of the disease limit the individuals; participation in activities and social life in their daily lives, causing the patients, physical performance, social roles and quality of life to be negatively affected. It is important to ensure the physical, social and psychological well-being of individuals diagnosed with MS, to increase their quality of life and to ensure their active and healthy participation in economic and social life. Considering the characteristics of MS disease, factors such as being chronic and irreversible, progressing with attacks, uncertainty in the treatment and disease process, and side effects of the drugs used negatively affect the physical and psychological health of individuals. In the health service to be provided to individuals diagnosed with MS, it is necessary to work on new methods and techniques in addition to medical approaches. It is important to provide holistic nursing care to MS patients, which includes not only symptom treatment but also the psychosocial status of the patient and addresses the patients problems from every aspect. Holistic nursing care, which addresses the patient problems from every aspect, forms the basis of the Human Care Model of nursing theorist Jean Watson. For Watson, nursing care is a professional, aesthetic, moral and scientific interpersonal process with the interaction of two individuals in terms of physical, spiritual, sociocultural and mental aspects. Watsons Human Care Model consists of the common sharing of core values in interaction and trust, disease prevention and health promotion, teaching-learning, holistic-alternative help practices, the individuals free will and autonomy-autonomy, the harmony of emotional and spiritual needs and scientific problem solving in decision making. The Human Caring Model values holistic practices by considering the concepts of soul-body-mental as a whole. When the studies in the literature are examined, it has been presented that nursing care based on Watsons Human Caring Model increases the quality of life in various diagnosed patient groups, reduces depression and pain, increases sleep quality and provides glycemic control. However, to our knowledge, no research has been conducted on individuals with MS based on Watsons Human Caring Model. Based on the idea that the model to be used will cause a positive change in the quality of life of MS patients, it is anticipated that this model-based research, which is preferred, can guide the treatment, support and counseling services that nurses provide to MS patients and strengthen nursing care.
Purpose of the Study This study is to determine the effect of nursing care based on Watsons Human Caring Model on the quality of life of patients with MS.
Hypotheses of the Study H0: Nursing care based on Watsons Human Caring Model has no effect on the quality of life of MS patients.
H1: Nursing care based on Watsons Human Caring Model has an effect on the quality of life of MS patients.
- Conditions
- Nursing Caries
- Being tested
- Nursing interventions based on the Watson Human Caring Model
- Keywords
- Nursing Care, Multiple Sclerosis, Quality of Life, Watson human care model
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing interventions based on the Watson Human Caring ModelBehavioural
In the literature review, it was noticed that nursing care based on the Watson Human Caring Model was applied to various patient groups but not to patients with MS.
| Study group | Role | What they receive |
|---|---|---|
| "intervention" | Experimental | When the studies in the literature are examined, it has been presented that nursing care based on Watson's Human Caring Model increases the quality of life in various diagnosed patient groups, reduces depression and pain, increases sleep quality and provides glycemic control . However, to our knowledge, no research has been conducted on individuals with MS based on Watson's Human Caring Model. Based on the idea that the model to be used will cause a positive change in the quality of life of MS patients, it is anticipated that this model-based research, which is preferred, can guide the treatment, support and counseling services that nurses provide to MS patients and strengthen nursing care. Receives: Behavioral: Nursing interventions based on the Watson Human Caring Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Quality of Life (MSQOL)-54 scale
The effect of nursing care on quality of life
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 May 2022
- Primary completion28 Oct 2024 (estimated)
- Study completion28 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention Group Procedure 4 interviews were conducted with patients in this group and in each interview, patients were given MS Symptom Management and Relaxation Exercise training. Nursing care based on the Human Care Model was provided. Control Group Procedure No intervention other than routine treatment and care was applied to the patients in the control group. Data Collection Form, MS Quality of Life Scale were applied to the patients. Face-to-face interviews were conducted with these patients two and a half months after the first interview and the MS Quality of Life Scale was applied again. After the study ended, between June and November 2023, Watson Human Care Model Based Nursing Care was applied to the patients in this group (1 patient could not attend the planned interviews due to a change of province and 1 patient could not take leave from work).
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatma İlknur ÇINAR, Prof. Dr., Study director, SBÜ Gülhane Hemşirelik Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634758
- Sponsor's protocol ID
- a3xktrbv
- Status last verified
- Oct 2023
- First submitted
- 17 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not prefer this work to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Nursing Care Based On Watson's Human Care Model On Quality Of Life Of Patients iıth Multıple Sclerosis
- ClinicalTrials.gov ID
- NCT06634758
- Acronym / sponsor ID
- a3xktrbv
- Conditions
- Nursing Caries
- Keywords
- Nursing Care, Multiple Sclerosis, Quality of Life, Watson human care model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Oct 2024 (estimated)
- Study completion
- 28 Nov 2024 (estimated)
- First posted
- 10 Oct 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.
Purpose: This study was conducted to determine the effect of nursing care based on Watsons Human Caring Model on the quality of life of patients with MS.
Materials and Methods: This randomized controlled study was conducted in Gülhane Training and Research Hospital, Neurology Department Outpatient Clinic between January and November 2023.Patients were assigned to groups according to block randomization. The study was conducted with a total of 74 patients, 37 in the intervention and 37 in the control group. Four interviews were conducted with the patients, and a nursing care protocol based on the Watson Human Caring Model was applied. Patients in the control group underwent routine procedure. The "Multiple Sclerosis Symptom Management Booklet" and "Relaxation Exercises" educational materials used in the study were evaluated with the DISCERN measurement tool and the written materials evaluation form. Research data were obtained using the Data Collection Form, MS Quality of Life Scale, Watson Patient Satisfaction Form and Semi-Structured Interview Form.
Keywords: Watson Human Caring Model, MS, nursing care, quality of life.
Detailed description
Multiple Sclerosis (MS) is a chronic disease that usually affects young adults, progresses with attacks and remissions, causes widespread demyelinating lesions in the central nervous system, and can lead to functional limitations, disability, or a decrease in quality of life. It is reported that the number of individuals diagnosed with MS is approximately 58 thousand in our country and more than 2.9 million worldwide. This means that one person is diagnosed with MS every five minutes worldwide. According to the data of the Turkish Statistical Institute , MS ranks sixth among causes of death in 2022 with 3.5% and first among diseases that cause disability . According to TUİK data, 153 people died due to MS in 2021 and 138 people died in 2022 . As can be understood from the high rates of disability and death, MS is an important disease that critically affects people\'s lives and quality of life. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve and spinal cord; over time, it turns into a neurodegenerative disease associated with lack of neurotrophic support and neuron loss. Depending on the location and degree of degeneration of sensory and/or motor neurons during the course of the disease, various neurological disorders such as gait disturbance, loss of balance, muscle strength loss, fatigue, cognitive impairment and sensory loss occur alone or together. The physical, psychosocial and cognitive deficiencies caused by all these disorders and the chronic course of the disease limit the individuals; participation in activities and social life in their daily lives, causing the patients, physical performance, social roles and quality of life to be negatively affected. It is important to ensure the physical, social and psychological well-being of individuals diagnosed with MS, to increase their quality of life and to ensure their active and healthy participation in economic and social life. Considering the characteristics of MS disease, factors such as being chronic and irreversible, progressing with attacks, uncertainty in the treatment and disease process, and side effects of the drugs used negatively affect the physical and psychological health of individuals. In the health service to be provided to individuals diagnosed with MS, it is necessary to work on new methods and techniques in addition to medical approaches. It is important to provide holistic nursing care to MS patients, which includes not only symptom treatment but also the psychosocial status of the patient and addresses the patients problems from every aspect. Holistic nursing care, which addresses the patient problems from every aspect, forms the basis of the Human Care Model of nursing theorist Jean Watson. For Watson, nursing care is a professional, aesthetic, moral and scientific interpersonal process with the interaction of two individuals in terms of physical, spiritual, sociocultural and mental aspects. Watsons Human Care Model consists of the common sharing of core values in interaction and trust, disease prevention and health promotion, teaching-learning, holistic-alternative help practices, the individuals free will and autonomy-autonomy, the harmony of emotional and spiritual needs and scientific problem solving in decision making. The Human Caring Model values holistic practices by considering the concepts of soul-body-mental as a whole. When the studies in the literature are examined, it has been presented that nursing care based on Watsons Human Caring Model increases the quality of life in various diagnosed patient groups, reduces depression and pain, increases sleep quality and provides glycemic control. However, to our knowledge, no research has been conducted on individuals with MS based on Watsons Human Caring Model. Based on the idea that the model to be used will cause a positive change in the quality of life of MS patients, it is anticipated that this model-based research, which is preferred, can guide the treatment, support and counseling services that nurses provide to MS patients and strengthen nursing care.
Purpose of the Study This study is to determine the effect of nursing care based on Watsons Human Caring Model on the quality of life of patients with MS.
Hypotheses of the Study H0: Nursing care based on Watsons Human Caring Model has no effect on the quality of life of MS patients.
H1: Nursing care based on Watsons Human Caring Model has an effect on the quality of life of MS patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention Group Procedure 4 interviews were conducted with patients in this group and in each interview, patients were given MS Symptom Management and Relaxation Exercise training. Nursing care based on the Human Care Model was provided. Control Group Procedure No intervention other than routine treatment and care was applied to the patients in the control group. Data Collection Form, MS Quality of Life Scale were applied to the patients. Face-to-face interviews were conducted with these patients two and a half months after the first interview and the MS Quality of Life Scale was applied again. After the study ended, between June and November 2023, Watson Human Care Model Based Nursing Care was applied to the patients in this group (1 patient could not attend the planned interviews due to a change of province and 1 patient could not take leave from work).
| Arm | Type | Receives |
|---|---|---|
| "intervention" | Experimental | Behavioral: Nursing interventions based on the Watson Human Caring ModelWhen the studies in the literature are examined, it has been presented that nursing care based on Watson's Human Caring Model increases the quality of life in various diagnosed patient groups, reduces depression and pain, increases sleep quality and provides glycemic control . However, to our knowledge, no research has been conducted on individuals with MS based on Watson's Human Caring Model. Based on the idea that the model to be used will cause a positive change in the quality of life of MS patients, it is anticipated that this model-based research, which is preferred, can guide the treatment, support and counseling services that nurses provide to MS patients and strengthen nursing care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a score between 3-7 on the Expanded Disability Status Scale (EDSS) (Puz et al., 2018) divided the patients into two groups as EDSS\<3 and EDSS≥3 and reported that the frequency of comorbidity was high in patients with EDSS scores of 3 and above. For this reason, patients with EDSS scores below 3 were not included in the study. In addition, patients with EDSS scores above 7 are dependent on the caregiver/helper. Since the quality of life of dependent patients may be affected by the caregiver, patients with EDSS scores above 7 were not included in the study).
Key exclusion criteria (4 listed)
- Having an attack during the research process
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 |
|---|---|---|
| Nursing interventions based on the Watson Human Caring ModelIn the literature review, it was noticed that nursing care based on the Watson Human Caring Model was applied to various patient groups but not to patients with MS. | Behavioural | "intervention" |
Primary outcome
Multiple Sclerosis Quality of Life (MSQOL)-54 scale
Time frame: 10 weeks
The effect of nursing care on quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No. I do not prefer this work to be shared.
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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.
Fatma İlknur ÇINAR, Prof. Dr. study director
SBÜ Gülhane Hemşirelik Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing interventions based on the Watson Human Caring Model in people with Nursing Caries, run by Saglik Bilimleri Universitesi 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 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?
Results are not available in the source record.
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?
Multiple Sclerosis Quality of Life (MSQOL)-54 scale (time frame: 10 weeks). 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 10 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.