HopeNCT04415411
Effects of Nursing Care Provided to Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope
A study testing Nursing care based on the Theory of Human Caring in people with Hope and Spirituality, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effects of nursing care provided based on the Watson's Theory of Human Caring to the relatives of palliative care patients on caregivers' spiritual well-being and hope. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hope, Spirituality, Palliative Care
- What is being tested?
- Nursing care based on the Theory of Human Caring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2018to 18 Mar 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 and above
- willingness and motivation to participate in research
- literacy
- being the primary caregiver
- lack of mental or verbal deficiency to respond the questions
Who cannot join
- aged 18 below
- unwilling to participate in research
- illiterate
- non-primary caregiver
- mental or communicative disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nursing Care Provided to the Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope: A Randomised Controlled Trial
The aim of this study is to determine the effects of nursing care provided based on the Watson's Theory of Human Caring to the relatives of palliative care patients on caregivers' spiritual well-being and hope. This research was conducted with 60 patient relatives (intervention group: 30, control group: 30) taking care of their patient in palliative care unit.
Read the detailed description
Every year, millions of patients as well as millions of patients are primarily involved in the palliative care process. It is emphasized that from the very start of palliative care process until grievance stage, patient relatives require a myriad of physical, psychological, social and spiritual needs. It has been widely reported that among relatives of palliative care patients, there is a high incidence of mental distress, depression, anxiety, sleep disturbance, fear and despair. The maintain of hope and spiritual well-being are important in dealing with this difficult process. Accordingly, nursing care is important, which supports the hope and spiritual well-being of patients' relatives. Nursing care that supports hope and focuses on spiritual dimensions is important in Watson's Human Care Theory.
- Conditions
- Hope, Spirituality, Palliative Care
- Being tested
- Nursing care based on the Theory of Human Caring
- Keywords
- family members, hope, nursing care, palliative care, spirituality, relatives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing care based on the Theory of Human CaringOther
Planned nursing care based on 10 caritas processes of Theory of Human Caring.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Routine nursing care |
| Intervention group | Experimental | Nursing care based on the Theory of Human Caring Receives: Other: Nursing care based on the Theory of Human Caring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopeless level of patient relatives
Data were collected via Beck Hopelessness Scale. Maximum score to obtain from the scale varies in between 0-20. Higher scores obtained indicate that there is a high level of hopelessness in an individual.
Measured: 1. week
Spiritual well-being level of patient relatives
Data were collected via Spiritual Well-Being Scale. Maximum score to obtain from the scale varies between 29-145. Higher score indicates stronger spiritual well-being.
Measured: 1. week
Secondary outcomes (2)
Hopeless level of patient relatives (Change in level of hopeless after 4 weeks)
Data were collected via Beck Hopelessness Scale. Maximum score to obtain from the scale varies in between 0-20. Higher scores obtained indicate that there is a high level of hopelessness in an individual.
Measured: 4 weeks
Spiritual well-being level of patient relatives (Change in level of spiritual well-being after 4 weeks)
Data were collected via Spiritual Well-Being Scale. Maximum score to obtain from the scale varies between 29-145. Higher score indicates stronger spiritual well-being.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start5 Oct 2018
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HopeStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, there are two groups as intervention group and control group. Investigator, administered not any application to control group. Nursing care which based on the Theory of Human Caring was given to intervention group for 4 weeks.
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Kurtgöz, Ondokuz Mayıs University
- Investigators
- Aslı Kurtgöz, PhD, Principal investigator, Amasya UniversityZeliha Koc, PhD, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415411
- Sponsor's protocol ID
- Interventional
- Other IDs
- PYO. SBF.1904.19.006
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans
Publications
De Korte-Verhoef MC, Pasman HR, Schweitzer BP, Francke AL, Onwuteaka-Philipsen BD, Deliens L. Burden for family carers at the end of life; a mixed-method study of the perspectives of family carers and GPs. BMC Palliat Care. 2014 Mar 31;13(1):16. doi: 10.1186/1472-684X-13-16.
PubMed 24678941Gotze H, Brahler E, Gansera L, Polze N, Kohler N. Psychological distress and quality of life of palliative cancer patients and their caring relatives during home care. Support Care Cancer. 2014 Oct;22(10):2775-82. doi: 10.1007/s00520-014-2257-5. Epub 2014 May 9.
PubMed 24811216Ullrich A, Ascherfeld L, Marx G, Bokemeyer C, Bergelt C, Oechsle K. Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients. BMC Palliat Care. 2017 May 10;16(1):31. doi: 10.1186/s12904-017-0206-z.
PubMed 28486962Oechsle K, Ullrich A, Marx G, Benze G, Heine J, Dickel LM, Zhang Y, Wowretzko F, Wendt KN, Nauck F, Bokemeyer C, Bergelt C. Psychological burden in family caregivers of patients with advanced cancer at initiation of specialist inpatient palliative care. BMC Palliat Care. 2019 Nov 18;18(1):102. doi: 10.1186/s12904-019-0469-7.
PubMed 31739802
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nursing Care Provided to the Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04415411
- Acronym / sponsor ID
- Interventional
- Conditions
- Hope, Spirituality, Palliative Care
- Keywords
- family members, hope, nursing care, palliative care, spirituality, relatives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 4 Jun 2020 (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.
The aim of this study is to determine the effects of nursing care provided based on the Watson's Theory of Human Caring to the relatives of palliative care patients on caregivers' spiritual well-being and hope. This research was conducted with 60 patient relatives (intervention group: 30, control group: 30) taking care of their patient in palliative care unit.
Detailed description
Every year, millions of patients as well as millions of patients are primarily involved in the palliative care process. It is emphasized that from the very start of palliative care process until grievance stage, patient relatives require a myriad of physical, psychological, social and spiritual needs. It has been widely reported that among relatives of palliative care patients, there is a high incidence of mental distress, depression, anxiety, sleep disturbance, fear and despair. The maintain of hope and spiritual well-being are important in dealing with this difficult process. Accordingly, nursing care is important, which supports the hope and spiritual well-being of patients' relatives. Nursing care that supports hope and focuses on spiritual dimensions is important in Watson's Human Care Theory.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, there are two groups as intervention group and control group. Investigator, administered not any application to control group. Nursing care which based on the Theory of Human Caring was given to intervention group for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine nursing care |
| Intervention group | Experimental | Other: Nursing care based on the Theory of Human CaringNursing care based on the Theory of Human Caring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 and above
- willingness and motivation to participate in research
- literacy
- being the primary caregiver
- lack of mental or verbal deficiency to respond the questions
Key exclusion criteria (5 listed)
- aged 18 below
- unwilling to participate in research
- illiterate
- non-primary caregiver
- mental or communicative disabilities
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 the Theory of Human CaringPlanned nursing care based on 10 caritas processes of Theory of Human Caring. | Other | Intervention group |
Primary outcome
Hopeless level of patient relatives
Time frame: 1. week
Data were collected via Beck Hopelessness Scale. Maximum score to obtain from the scale varies in between 0-20. Higher scores obtained indicate that there is a high level of hopelessness in an individual.
Spiritual well-being level of patient relatives
Time frame: 1. week
Data were collected via Spiritual Well-Being Scale. Maximum score to obtain from the scale varies between 29-145. Higher score indicates stronger spiritual well-being.
2 secondary outcomes
Hopeless level of patient relatives (Change in level of hopeless after 4 weeks)
Time frame: 4 weeks
Spiritual well-being level of patient relatives (Change in level of spiritual well-being after 4 weeks)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 24678941De Korte-Verhoef MC, Pasman HR, Schweitzer BP, Francke AL, Onwuteaka-Philipsen BD, Deliens L. Burden for family carers at the end of life; a mixed-method study of the perspectives of family carers and GPs. BMC Palliat Care. 2014 Mar 31;13(1):16. doi: 10.1186/1472-684X-13-16.
- Background: PubMed 24811216Gotze H, Brahler E, Gansera L, Polze N, Kohler N. Psychological distress and quality of life of palliative cancer patients and their caring relatives during home care. Support Care Cancer. 2014 Oct;22(10):2775-82. doi: 10.1007/s00520-014-2257-5. Epub 2014 May 9.
- Background: PubMed 28486962Ullrich A, Ascherfeld L, Marx G, Bokemeyer C, Bergelt C, Oechsle K. Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients. BMC Palliat Care. 2017 May 10;16(1):31. doi: 10.1186/s12904-017-0206-z.
- Background: PubMed 31739802Oechsle K, Ullrich A, Marx G, Benze G, Heine J, Dickel LM, Zhang Y, Wowretzko F, Wendt KN, Nauck F, Bokemeyer C, Bergelt C. Psychological burden in family caregivers of patients with advanced cancer at initiation of specialist inpatient palliative care. BMC Palliat Care. 2019 Nov 18;18(1):102. doi: 10.1186/s12904-019-0469-7.
- WHO (2019). Palliative careLink provided by the sponsor.
- Canadian Cancer Research Alliance (2017). Pan-canadian framework for palliative and end-of life care researchLink provided by the sponsor.
- Watson, J. (2010). Core concepts of Jean Watson's Theory of human caring/caring science.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There are no plans
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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.
Aslı Kurtgöz, PhD principal investigator
Amasya University
Zeliha Koc, PhD principal investigator
Ondokuz Mayıs University
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 the Theory of Human Caring in people with Hope and Spirituality, run by Ondokuz Mayıs University 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hopeless level of patient relatives (time frame: 1. week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415411, which also lists 4 linked publications.
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 9 Jun 2020.