NCT06634758

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

September 17, 2024

Last Update Submit

October 8, 2024

Conditions

Keywords

Nursing CareMultiple SclerosisQuality of LifeWatson human care model

Outcome Measures

Primary Outcomes (1)

  • Multiple Sclerosis Quality of Life (MSQOL)-54 scale

    The effect of nursing care on quality of life

    10 weeks

Study Arms (1)

"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.

Behavioral: Nursing interventions based on the Watson Human Caring Model

Interventions

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.

"intervention"

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi

Ankara, Keçiören, 06310, Turkey (Türkiye)

Location

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

  • Fatma İlknur ÇINAR, Prof. Dr.

    SBÜ Gülhane Hemşirelik Fakültesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2024

First Posted

October 10, 2024

Study Start

May 1, 2022

Primary Completion

October 28, 2024

Study Completion

November 28, 2024

Last Updated

October 10, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

I do not prefer this work to be shared.

Locations