Elderly (People Aged 65 or More)NCT07050901
Theory of Kolcaba on the Quality of Life and Psychological Well-Being Levels of the Aged People
A study testing Nursing Care Based on Kolcaba's Comfort Theory in people with Elderly (People Aged 65 or More) and Quality of Life, run by Merve OZKAN at 1 site in Turkey (Türkiye).
Trial summary
A randomised controlled study will be conducted to determine the effect of nursing care based on Kolcaba's comfort theory on the quality of life and psychological well-being levels of the elderly. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly (People Aged 65 or More), Quality of Life, Psychological Well-being
- What is being tested?
- Nursing Care Based on Kolcaba's Comfort Theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Volunteered to participate in the research,
- Residing in Aydın,
- No mental disability,
- 65 years of age or older,
- At least primary school graduate (since the scales should be filled in by self-report method),
- individuals who can speak and write Turkish language were included.
Who cannot join
- individuals staying in nursing homes/nursing homes were excluded from the scope of the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
AydınAdnan Menderes University institute of health sciences
Aydin, Efeler, 09010
About this study
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Quality of Life and Psychological Well-Being Levels of the Aged People
A randomised controlled study will be conducted to determine the effect of nursing care based on Kolcaba's comfort theory on the quality of life and psychological well-being levels of the elderly.
Read the detailed description
The aim of this study was to determine the effect of nursing care based on Kolcaba's comfort theory on the quality of life and psychological well-being levels of the elderly. This study is a randomized controlled experimental research. The population of the study consisted of 775 individuals aged 65 and over residing in Çeştepe and Tepecik neighborhoods of Efeler district of Aydın province, and the sample consisted of a total of 112 individuals, 56 in the experimental group and 56 in the control group. The data of the study were collected with the questionnaire form prepared by the researcher, Quality of Life Scale in the Elderly and Psychological Well-Being Scale in the Elderly. Each intervention was planned for one and a half hours, 1 day a week for 8 weeks, and each session was carried out individually for the experimental group through home visits. Follow-up measurements were made at the 1st month and 3rd month after the interventions of the experimental group were completed. The control group did not receive any intervention until the end of the study and follow-up measurements were performed at the 1st month and 3rd month after the first measurement. Descriptive statistical analyses, Mann Whitney U, Likelihood Ratio, Pearson chi-square and Friedman tests were used for comparisons outside normal distribution. The Kolmogorov-Smirnov test was used to evaluate normal distribution as a baseline analysis; values at p<0.05 level were considered statistically significant. Ethics committee, mukhtar's office, scale use permissions and participant written consents were obtained. When the sociodemographic characteristics of the elderly in the experimental and control groups were compared, it was found that there was a significant difference in terms of social security and having a chronic disease, in the comparison of the mean scores of the total and sub-dimensions of the Quality of Life in the Elderly Scale of the 1st and 2nd Measurement before and after the training of the elderly in the experimental and control groups; no difference was found before the training, and the mean scores of the elderly in the experimental group were higher than the control group. measurement autonomy sub-dimension, post-training 1st measurement pleasure sub-dimension, post-training 1st measurement self-actualization sub-dimension and post-training 1st measurement Quality of Life in the Elderly Scale total mean scores were higher than the control group.
When the pre-training, post-training (1st and 2nd measurements) mean scores of the Quality of Life Scale for the Elderly (total and sub-dimensions) were compared within the experimental group, a statistically significant difference was found in the self-realization sub-dimension. Furthermore, when the total mean scores of the Psychological Well-Being Scale for the Elderly were compared at the same time points within the experimental group, a statistically significant difference was observed (p < 0.05).
In the control group, when the pre-training, post-training (1st and 2nd measurements) mean scores of the Quality of Life Scale for the Elderly (total and sub-dimensions) were compared, statistically significant differences were observed in the total score, as well as in the control, autonomy, pleasure, and self-realization sub-dimensions. Additionally, a significant difference was found in the total mean scores of the Psychological Well-Being Scale for the Elderly across the same time points in the control group (p < 0.05).
In the experimental group, statistically significant increases were observed in the total score of the Quality of Life Scale and in the sub-dimensions of autonomy, pleasure, and self-realization, as well as in the scores of the Psychological Well-Being Scale following the training. Although some significant differences were also identified in certain sub-dimensions over time within the control group, the increases observed in the experimental group were more pronounced and statistically significant. These findings suggest that the training provided had a positive impact on the quality of life and psychological well-being levels of elderly individuals.
- Being tested
- Nursing Care Based on Kolcaba's Comfort Theory
- Keywords
- quailty of life, nursing, psychological well-being, elderly
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Care Based on Kolcaba's Comfort TheoryOther
Kolcaba's Nursing Care Applications Based on Comfort Theory were carried out individually; each application was planned for one and a half hours, one day a week and for 8 weeks, and each session was carried out for each individual through home visits. The topics of Nursing Care Based on Kolcaba's Comfort Theory were; Physical Care Practices (2 weeks), Psychospiritual Care Practices (2 weeks), Environmental Care Practices (2 weeks) and Sociocultural Care Practices (2 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | The experimental group will receive training on Nursing Care Based on Kolcaba's Comfort Theory. For the individuals in the experimental group, follow-up measurements will be made in the 1st month and 3rd month after the completion of Kolcaba's Nursing Care Based on Comfort Theory training. Receives: Other: Nursing Care Based on Kolcaba's Comfort Theory |
| Control group | No intervention | The control group continued to receive the routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
experimental group measurement
measurement of quality of life and psychological well-being levels of the elderly up to 5 months with a questionnaire form
Measured: September 2023
Secondary outcomes (1)
control group measurement
up to 3 months measurement of quality of life and psychological well-being levels of the elderly with a questionnaire form
Measured: December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly (People Aged 65 or More)Studies 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
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merve OZKAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merve OZKAN, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050901
- Sponsor's protocol ID
- Interventional studies
- Status last verified
- Jul 2025
- First submitted
- 4 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Quality of Life and Psychological Well-Being Levels of the Aged People
- ClinicalTrials.gov ID
- NCT07050901
- Acronym / sponsor ID
- Interventional studies
- Keywords
- quailty of life, nursing, psychological well-being, elderly
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Merve OZKANUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 Jul 2025 (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.
A randomised controlled study will be conducted to determine the effect of nursing care based on Kolcaba's comfort theory on the quality of life and psychological well-being levels of the elderly.
Detailed description
The aim of this study was to determine the effect of nursing care based on Kolcaba's comfort theory on the quality of life and psychological well-being levels of the elderly. This study is a randomized controlled experimental research. The population of the study consisted of 775 individuals aged 65 and over residing in Çeştepe and Tepecik neighborhoods of Efeler district of Aydın province, and the sample consisted of a total of 112 individuals, 56 in the experimental group and 56 in the control group. The data of the study were collected with the questionnaire form prepared by the researcher, Quality of Life Scale in the Elderly and Psychological Well-Being Scale in the Elderly. Each intervention was planned for one and a half hours, 1 day a week for 8 weeks, and each session was carried out individually for the experimental group through home visits. Follow-up measurements were made at the 1st month and 3rd month after the interventions of the experimental group were completed. The control group did not receive any intervention until the end of the study and follow-up measurements were performed at the 1st month and 3rd month after the first measurement. Descriptive statistical analyses, Mann Whitney U, Likelihood Ratio, Pearson chi-square and Friedman tests were used for comparisons outside normal distribution. The Kolmogorov-Smirnov test was used to evaluate normal distribution as a baseline analysis; values at p<0.05 level were considered statistically significant. Ethics committee, mukhtar's office, scale use permissions and participant written consents were obtained. When the sociodemographic characteristics of the elderly in the experimental and control groups were compared, it was found that there was a significant difference in terms of social security and having a chronic disease, in the comparison of the mean scores of the total and sub-dimensions of the Quality of Life in the Elderly Scale of the 1st and 2nd Measurement before and after the training of the elderly in the experimental and control groups; no difference was found before the training, and the mean scores of the elderly in the experimental group were higher than the control group. measurement autonomy sub-dimension, post-training 1st measurement pleasure sub-dimension, post-training 1st measurement self-actualization sub-dimension and post-training 1st measurement Quality of Life in the Elderly Scale total mean scores were higher than the control group.
When the pre-training, post-training (1st and 2nd measurements) mean scores of the Quality of Life Scale for the Elderly (total and sub-dimensions) were compared within the experimental group, a statistically significant difference was found in the self-realization sub-dimension. Furthermore, when the total mean scores of the Psychological Well-Being Scale for the Elderly were compared at the same time points within the experimental group, a statistically significant difference was observed (p < 0.05).
In the control group, when the pre-training, post-training (1st and 2nd measurements) mean scores of the Quality of Life Scale for the Elderly (total and sub-dimensions) were compared, statistically significant differences were observed in the total score, as well as in the control, autonomy, pleasure, and self-realization sub-dimensions. Additionally, a significant difference was found in the total mean scores of the Psychological Well-Being Scale for the Elderly across the same time points in the control group (p < 0.05).
In the experimental group, statistically significant increases were observed in the total score of the Quality of Life Scale and in the sub-dimensions of autonomy, pleasure, and self-realization, as well as in the scores of the Psychological Well-Being Scale following the training. Although some significant differences were also identified in certain sub-dimensions over time within the control group, the increases observed in the experimental group were more pronounced and statistically significant. These findings suggest that the training provided had a positive impact on the quality of life and psychological well-being levels of elderly individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Other: Nursing Care Based on Kolcaba's Comfort TheoryThe experimental group will receive training on Nursing Care Based on Kolcaba's Comfort Theory. For the individuals in the experimental group, follow-up measurements will be made in the 1st month and 3rd month after the completion of Kolcaba's Nursing Care Based on Comfort Theory training. |
| Control group | No intervention | –The control group continued to receive the routine care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Volunteered to participate in the research,
- Residing in Aydın,
- No mental disability,
- 65 years of age or older,
- At least primary school graduate (since the scales should be filled in by self-report method),
Key exclusion criteria (1 listed)
- individuals staying in nursing homes/nursing homes were excluded from the scope of the study.
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 Care Based on Kolcaba's Comfort TheoryKolcaba's Nursing Care Applications Based on Comfort Theory were carried out individually; each application was planned for one and a half hours, one day a week and for 8 weeks, and each session was carried out for each individual through home visits. The topics of Nursing Care Based on Kolcaba's Comfort Theory were; Physical Care Practices (2 weeks), Psychospiritual Care Practices (2 weeks), Environmental Care Practices (2 weeks) and Sociocultural Care Practices (2 weeks). | Other | Experiment group |
Primary outcome
experimental group measurement
Time frame: September 2023
measurement of quality of life and psychological well-being levels of the elderly up to 5 months with a questionnaire form
1 secondary outcome
control group measurement
Time frame: December 2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Care Based on Kolcaba's Comfort Theory in people with Elderly (People Aged 65 or More) and Quality of Life, run by Merve OZKAN 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 6 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
experimental group measurement (time frame: September 2023). 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 3 Jul 2025.