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
1 other identifier
interventional
55
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Shorter than P25 for not_applicable
1 active site
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
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2018
CompletedFirst Submitted
Initial submission to the registry
October 2, 2018
CompletedFirst Posted
Study publicly available on registry
October 3, 2018
CompletedMay 10, 2022
May 1, 2022
2 months
October 2, 2018
May 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Loneliness Scale for the Elderly
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.
12 weeks
Secondary Outcomes (6)
International Physical Activity Questionnaire
12 weeks
Health Status Perception Scale
12 weeks
Social Inclusion Scale
12 weeks
Multidimensional Scale of Perceived Social Support
12 weeks
Well-being Index
12 weeks
- +1 more secondary outcomes
Study Arms (2)
intervention group
EXPERIMENTAL1. Group-based interventions Group-based interventions include physical activity, sightseeing, picnics, theater, cinema, group educations. 2. Individual interventions Individual interventions include interventions in the Omaha System Nursing Interventions Scheme that is specific to health problems of elderly women.
control group
NO INTERVENTIONThe control group will not take any intervention, the post-tests will be collected at the end of 12 weeks.
Interventions
1. Group-based interventions Elderly women will have a walk for physical activity for 12 weeks, three days a week. It is planned that each of the sightseeing, picnic, theater and cinema activities will be done twice. The topics that elderly women need most for group educations will be determined. Group educations will be held once every four weeks approximately three hours. 2. Individual interventions After the pre-tests are applied to the women in the intervention group, the home environment and the individual's health problems will be assessed, interventions will be implemented and the results will be evaluated during home visits at online. During the home visit to the elderly women and twelve-week intervention period, each woman will meet four times and initiatives will be implemented.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akdeniz University
Antalya, 07058, Turkey (Türkiye)
Related Publications (1)
Ilgaz A, Gozum S. Effectiveness of INOSEL program consisting of Integrative Nursing and Omaha System for older women feeling loneliness: a randomised controlled trial. Aging Clin Exp Res. 2023 Nov;35(11):2769-2781. doi: 10.1007/s40520-023-02559-9. Epub 2023 Sep 28.
PMID: 37759148DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ayşegül ILGAZ
Research Assistant
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
October 2, 2018
First Posted
October 3, 2018
Study Start
January 1, 2018
Primary Completion
February 28, 2018
Study Completion
May 15, 2018
Last Updated
May 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- one year
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