- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03695133
Nursing Care Interventions According to Integrative Nursing and Omaha System in Elderly Women Feeling Loneliness (INOSEL)
Effects of Nursing Care Interventions According to Integrative Nursing and Omaha System in Elderly Women Feeling Loneliness: Study Protocol for a Randomized Controlled Trial
Objectives: The present study investigates the effects of nursing care interventions on the physical, psychological, social and spiritual health of the elderly women with high level of loneliness according to the principles of integrative nursing and Omaha System.
Methods: This study protocol describes a randomised controlled trial with to parallel group design. After the level of loneliness of elderly women will be determined by the Loneliness Scale for the Elderly in the Family Health Center, women with high levels of loneliness will be randomly assigned to the intervention and control group. Nursing care interventions consisting of group-based (sightseeing, picnics, theater, cinema) and individual according to Integrative Nursing and Omaha System. Elderly women who feel loneliness will continue for 12 weeks. Pre-tests and post-tests will be completed during home visits made by the researchers.
Discussion: This study will provide evidence regarding the effectiveness of nursing care interventions that include the comprehensive (physical, psychological, social and spiritual) evaluation of their health, and contribute to provide care in terms of Integrative Nursing and Omaha System.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Antalya, Turkey, 07058
- Akdeniz University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- to be independent according to the Katz Daily Activities Activity Scale;
- no problem in physical activity with the suggestion of the doctor in Family Health Center;
- living alone or with family;
- good cognitive state (place, time and person orientation) with the suggestion of the doctor; - the willingness to participate in the study
Exclusion Criteria:
- to live in any elderly care center or nursing home;
- to be semi-dependent and dependent according to the Katz Daily Activities Activity Scale
- to have a psychiatric disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: intervention group
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Other Names:
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NO_INTERVENTION: control group
The control group will not take any intervention, the post-tests will be collected at the end of 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loneliness Scale for the Elderly
Time Frame: 12 weeks
|
The loneliness scale for the elderly was developed to determine the sense of loneliness.
The two subscales in the scale are: emotional and social loneliness subscales.
There are 11 items in the binary Likert type scale.
Minumum and maximum scores are 0 and 22 points, respectively.
The total score is obtained by collecting the scores from the subscales.
Loneliness can be divided into four levels according to the score.
"0-4 scores" do not feel loneliness, "5-14 scores" acceptable loneliness, "15-18 scores" feeling very loneliness and "19-22 scores" feeling very lonely.
Levels increase the level of loneliness.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Physical Activity Questionnaire
Time Frame: 12 weeks
|
There are 7 questions in the short form of the questionnaire.
This measure assesses the types of intensity of physical activity.
The items in the short form were structured to provide separate scores on walking, moderate-intensity and vigorous-intensity activity.
Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Standard MET values for activities were established.
Total Work MET-minutes/week =sum of Walking+Moderate+Vigorous MET-minutes/week scores at work.
The score obtained is classified as non-physical activity (MET-600 energy level), insufficient physical activity level (MET = energy level between 600-3000) and adequate physical activity level (MET ≥ 3000 energy level).
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12 weeks
|
Health Status Perception Scale
Time Frame: 12 weeks
|
In order to determine the perception of health status, it is questioned how the individual evaluates his / her health now.
Very good (1), good (2), bad (3) and very bad (4) options on the scale, the lowest score is 4, the highest score is 1.
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12 weeks
|
Social Inclusion Scale
Time Frame: 12 weeks
|
Social inclusion scale evaluates that whether having the opportunities and resources to participate fully in economic, social and cultural life and to enjoy a standard of wellbeing that is considered normal in the society in which we live or not.
There are three subscales in the Lİkert type scale, consisting of 18 items: Social Isolation, Social Relations and Social Acceptance.
The lowest score is 1 and the highest score is 72.
As the score obtained from the scale increases, social inclusion is increasing.
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12 weeks
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Multidimensional Scale of Perceived Social Support
Time Frame: 12 weeks
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There are 12 items on the scale evaluating the adequacy of social support.
In this scale, there are three sub-dimensions: family, friend and special human support.
The sum of the obtained scores is collected separately for each subgroup and the sum of these groups gives the total score of the scale.
The lowest score is 4 and the highest score is 28 from subscales.
The lowest score is 12 and the highest score is 84 from total scale.
The higher the score, the higher the perceived social support.
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12 weeks
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Well-being Index
Time Frame: 12 weeks
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This index evaluates the general emotional state.
There are five items in the six-point likert type index.
Questions that ask individuals how they often feel in the last two weeks are scored from 0 to 5. In this index, the points taken from the questions are collected and multiplied by four to 0-100 points.
As the score from the index increases, it means that the emotional situation is good.
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12 weeks
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Healthy Life Style Behavior Scale II (spiritual development sub-scale)
Time Frame: 12 weeks
|
It was developed to measure health promotion behaviors of individuals.
The scale consists of 52 items and six factors (health responsibility, physical activity, nutrition, spiritual development, interpersonal relations and stress management).
In this study, spiritual development subscale was used.
Likert type scale is scored from 1 to 4. The lowest nine scores from the spiritual development subscale and the highest 36 points are taken.
Increasing the score from the scale indicates that the spiritual development is good.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayşegül ILGAZ, Research Assistant
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 001 (NavyGHB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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