Support, FamilyNCT06154759
The Effect of Psychoeducation on Hopelessness, Death Anxiety and Caregiver Burden
A study testing Watson Human Caring Model-based psychoeducation in people with Support, Family, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of Watson Human Caring Model-based psychoeducation given to the relatives of patients receiving palliative care on hopelessness, death anxiety and the burden of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Support, Family
- What is being tested?
- Watson Human Caring Model-based psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2022to 3 Mar 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to communicate in Turkish Ability to write in Turkish Being a primary relative of the patient The patient's relative has been in the clinic for at least one week in order to adapt to the caregiver role.
- Does not have a visual, auditory or mental disability Only one relative of each patient participated in the study. Provide care by the patient's relatives for at least eight hours a day
Who cannot join
- Inability to speak Turkish
- Having a hearing impairment
- Lack of comprehension skills
- Participating in another psychoeducation program within the last year
- Having a physical or mental problem t
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Psycoeducation Based on The Watson's Human Caring Model Provided To The Relatives Of Palliative Care Patients on Hopelessness, Death Anxiıety, And Burden of Care
This study was conducted to determine the effect of Watson Human Caring Model-based psychoeducation given to the relatives of patients receiving palliative care on hopelessness, death anxiety and the burden of care.
Read the detailed description
This randomized controlled study was conducted with the relatives of patients hospitalized in the palliative care clinic of a training and research hospital in Ankara,Turkey. A total of 66 patient relatives, 33 of whom were in the experimental group and 33 in the control group, were included in the study. In the study, quantitative data were collected using Descriptive Characteristics Form, Beck Hopelessness Scale, Templer Death Anxiety Scale and Caregiver Strain Index, while qualitative data were collected using Structured Interview Form-1 and Structured Interview Form-2. Quantitative data collection tools were applied to the relatives of the patients in the experimental and control groups after the randomization group assignment within the scope of the pre-test. Then, individual psychoeducation was given to the relatives of the patients in the experimental group for 45-60 minutes once a week for eight weeks. Qualitative data were collected in these psychoeducation sessions (sessions 2,3,5,7,8) and for this purpose, Structured Interview Form-1, Structured Interview Form-2, and audio recording were used.
- Conditions
- Support, Family
- Being tested
- Watson Human Caring Model-based psychoeducation
- Keywords
- Hopelessness, Death Anxiety, Burden of Care, Palliative care, Psychiatric Nursing
- Medical subject headings
- Necrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watson Human Caring Model-based psychoeducationOther
It is a psychoeducation program based on the Watson human care model, one of the theories of the nursing profession, that includes healing processes, and consists of sessions that address the hopelessness, death anxiety and care burden of individuals.
| Study group | Role | What they receive |
|---|---|---|
| experimental caregiver group | Experimental | 33 of whom were in the experimental group and 33 in the control group, were included in the study. In the study, quantitative data were collected using Descriptive Characteristics Form, Beck Hopelessness Scale, Templer Death Anxiety Scale and Caregiver Strain Index, while qualitative data were collected using Structured Interview Form-1 and Structured Interview Form-2. Quantitative data collection tools were applied to the relatives of the patients in the experimental and control groups after the randomization group assignment within the scope of the pre-test. Psychoeducation was given to the relatives of the patients in the experimental group for 45-60 minutes once a week for eight weeks. Qualitative data were collected in sessions (sessions 2,3,5,7,8) and for this purpose, Structured Interview Form-1, Structured Interview Form-2, and audio recording were used. The same data collection tools were applied to the Experiment group for the post-test measurements after eight weeks. Receives: Other: Watson Human Caring Model-based psychoeducation |
| control caregiver group | No intervention | In the study, quantitative data were collected using Descriptive Characteristics Form, Beck Hopelessness Scale, Templer Death Anxiety Scale and Caregiver Strain Index in control group. The control group received no intervention for eight weeks. The same data collection tools were applied to the Control group for the post-test measurements after eight weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metting-Encounter
caregiver is informed about topics included in psychoeducation program and discussed in weekly.
- Beck Hopelessness Scale (BHS) was used to determine the hopelessness. The items are answered as "Yes-No". Total score is between 0-20. As the score of the scale increases; interpreted as an increase in hopelessness in individuals.
- Templer Death Anxiety (TDA)Scale was used to determine the death anxiety. The total score that can be obtained from the scale is between 0-15, and values of seven and above are interpreted as high death anxiety. The items are answered as "True-False".
- The Caregiver Strain Index (CSI)was used to determine care burden. The items in the scale are answered as "Yes-No". The total score of the scale is between 0-13,the average score of the scale is seven and above; interpreted as the burden of care in individuals.
After psychoeducation,our aims are decreasing levels of
- For hopelessness, BHS used
- death anxiety, TDA used
- care burden, CSI used
Measured: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Understanding palliative care
Explaining the meaning of palliative care with the patient's relatives, discussing the common symptoms in patients.
data from the qualitative stage; It was obtained by using structured interview forms of the relatives of the patients in the experimental group during psychoeducation program based on. In the 2nd, 3rd, 5th,7th sessions of psychoeducation, six questions were asked about the hopelessness, death anxiety and care burden. In this session, "What is the meaning of giving care to the relatives of the patients in the structured interview form-1? How did the caregiving process affect you?" A qualitative interview was conducted by asking the question.
Measured: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Caregiving Process
Meeting with the caregiver about the difficulties and gains of the caregiving process In this session, "Can you share your experiences about the difficulties of the caregiving process? Can you tell about your experiences that made you feel good during the caregiving process?" A qualitative interview was conducted by asking the question.
Measured: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Hope- Sources of Hope
Interviewing the caregiver about the importance of hope in life
Measured: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Developing Hope
Meeting with the patient's relatives about what can be done to improve hope. In this session, "Can you share your experiences about the concept of hope in the care process?", "You are here with your patient right now, you are helping him, what are your expectations for the next days?" A qualitative interview was conducted by asking the question.
Measured: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Death- Death anxiety
Interviewing the concept of death with the patient's relatives, providing information on what can be done to cope with death anxiety while caring for a patient with a terminal diagnosis.
Measured: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Meaning of Life
Interviewing with the caregiver about the meaning of life. In this session, "Can you share with me your end-of-life experiences in the caregiving process according to your culture and belief?" A qualitative interview was conducted by asking the question.
Measured: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Last session
post test Beck Hopelessness Scale was used to determine the hopelessness levels of caregivers after psychoeducation. The scale has 20 items and these items are answered as "Yes-No". The total score is between 0-20. As the score of the scale increases; interpreted as an increase in hopelessness in individuals.
Templer Death Anxiety Scale was used to determine the death anxiety of caregivers after psychoeducation The total score that can be obtained from the scale is between 0-15, and values of seven and above are interpreted as high death anxiety. The items in the scale are answered as "True-False".
The Caregiver Strain Index was used to determine caregivers' burden of care after psychoeducation. items in the scale are answered as "Yes-No". The scale has no sub-dimensions. The scale's total score is between 0-13, and if the average score of the scale is seven and above; interpreted as the burden of care in individuals.
Measured: It will be applied once a week for 45-60 minutes for up to 8 weeks.Data collection forms (Descriptive Characteristics Form, Beck Hopelessness Scale, Templer Death Anxiety Scale and Caregiver Strain Index) applied again for post test to all caregivers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start20 Jul 2022
- Primary completion27 Feb 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Support, FamilyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Dilek Soyaslan, Ankara Medipol University
- Investigators
- Bilge SOYASLAN, Master, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154759
- Sponsor's protocol ID
- B.306565
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Best M, Leget C, Goodhead A, Paal P. An EAPC white paper on multi-disciplinary education for spiritual care in palliative care. BMC Palliat Care. 2020 Jan 15;19(1):9. doi: 10.1186/s12904-019-0508-4.
PubMed 31941486Valero-Cantero I, Casals C, Carrion-Velasco Y, Baron-Lopez FJ, Martinez-Valero FJ, Vazquez-Sanchez MA. The influence of symptom severity of palliative care patients on their family caregivers. BMC Palliat Care. 2022 Feb 28;21(1):27. doi: 10.1186/s12904-022-00918-3.
PubMed 35227246Del-Pino-Casado R, Priego-Cubero E, Lopez-Martinez C, Orgeta V. Subjective caregiver burden and anxiety in informal caregivers: A systematic review and meta-analysis. PLoS One. 2021 Mar 1;16(3):e0247143. doi: 10.1371/journal.pone.0247143. eCollection 2021.
PubMed 33647035Jors K, Seibel K, Bardenheuer H, Buchheidt D, Mayer-Steinacker R, Viehrig M, Xander C, Becker G. Education in End-of-Life Care: What Do Experienced Professionals Find Important? J Cancer Educ. 2016 Jun;31(2):272-8. doi: 10.1007/s13187-015-0811-6.
PubMed 25773135Alam S, Hannon B, Zimmermann C. Palliative Care for Family Caregivers. J Clin Oncol. 2020 Mar 20;38(9):926-936. doi: 10.1200/JCO.19.00018. Epub 2020 Feb 5.
PubMed 32023152Bischoff K, Yang E, Kojimoto G, Shepard Lopez N, Holland S, Calton B, Adkins SH, Cheng S, Miller BJ, Rabow MW. What We Do: Key Activities of an Outpatient Palliative Care Team at an Academic Cancer Center. J Palliat Med. 2018 Jul;21(7):999-1004. doi: 10.1089/jpm.2017.0441. Epub 2018 Feb 12.
PubMed 29431580Perpina-Galvan J, Orts-Beneito N, Fernandez-Alcantara M, Garcia-Sanjuan S, Garcia-Caro MP, Cabanero-Martinez MJ. Level of Burden and Health-Related Quality of Life in Caregivers of Palliative Care Patients. Int J Environ Res Public Health. 2019 Nov 29;16(23):4806. doi: 10.3390/ijerph16234806.
PubMed 31795461Nierop-van Baalen C, Grypdonck M, van Hecke A, Verhaeghe S. Associated factors of hope in cancer patients during treatment: A systematic literature review. J Adv Nurs. 2020 Jul;76(7):1520-1537. doi: 10.1111/jan.14344. Epub 2020 Mar 20.
PubMed 32133663Davis MP, Lagman R, Parala A, Patel C, Sanford T, Fielding F, Brumbaugh A, Gross J, Rao A, Majeed S, Shinde S, Rybicki LA. Hope, Symptoms, and Palliative Care. Am J Hosp Palliat Care. 2017 Apr;34(3):223-232. doi: 10.1177/1049909115627772. Epub 2016 Jul 10.
PubMed 26809826
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psycoeducation Based on The Watson's Human Caring Model Provided To The Relatives Of Palliative Care Patients on Hopelessness, Death Anxiıety, And Burden of Care
- ClinicalTrials.gov ID
- NCT06154759
- Acronym / sponsor ID
- B.306565
- Conditions
- Support, Family
- Keywords
- Hopelessness, Death Anxiety, Burden of Care, Palliative care, Psychiatric Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 4 Dec 2023 (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.
This study was conducted to determine the effect of Watson Human Caring Model-based psychoeducation given to the relatives of patients receiving palliative care on hopelessness, death anxiety and the burden of care.
Detailed description
This randomized controlled study was conducted with the relatives of patients hospitalized in the palliative care clinic of a training and research hospital in Ankara,Turkey. A total of 66 patient relatives, 33 of whom were in the experimental group and 33 in the control group, were included in the study. In the study, quantitative data were collected using Descriptive Characteristics Form, Beck Hopelessness Scale, Templer Death Anxiety Scale and Caregiver Strain Index, while qualitative data were collected using Structured Interview Form-1 and Structured Interview Form-2. Quantitative data collection tools were applied to the relatives of the patients in the experimental and control groups after the randomization group assignment within the scope of the pre-test. Then, individual psychoeducation was given to the relatives of the patients in the experimental group for 45-60 minutes once a week for eight weeks. Qualitative data were collected in these psychoeducation sessions (sessions 2,3,5,7,8) and for this purpose, Structured Interview Form-1, Structured Interview Form-2, and audio recording were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental caregiver group | Experimental | Other: Watson Human Caring Model-based psychoeducation33 of whom were in the experimental group and 33 in the control group, were included in the study. In the study, quantitative data were collected using Descriptive Characteristics Form, Beck Hopelessness Scale, Templer Death Anxiety Scale and Caregiver Strain Index, while qualitative data were collected using Structured Interview Form-1 and Structured Interview Form-2. Quantitative data collection tools were applied to the relatives of the patients in the experimental and control groups after the randomization group assignment within the scope of the pre-test. Psychoeducation was given to the relatives of the patients in the experimental group for 45-60 minutes once a week for eight weeks. Qualitative data were collected in sessions (sessions 2,3,5,7,8) and for this purpose, Structured Interview Form-1, Structured Interview Form-2, and audio recording were used. The same data collection tools were applied to the Experiment group for the post-test measurements after eight weeks. |
| control caregiver group | No intervention | –In the study, quantitative data were collected using Descriptive Characteristics Form, Beck Hopelessness Scale, Templer Death Anxiety Scale and Caregiver Strain Index in control group. The control group received no intervention for eight weeks. The same data collection tools were applied to the Control group for the post-test measurements after eight weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to communicate in Turkish Ability to write in Turkish Being a primary relative of the patient The patient's relative has been in the clinic for at least one week in order to adapt to the caregiver role.
- Does not have a visual, auditory or mental disability Only one relative of each patient participated in the study. Provide care by the patient's relatives for at least eight hours a day
Key exclusion criteria (5 listed)
- Inability to speak Turkish
- Having a hearing impairment
- Lack of comprehension skills
- Participating in another psychoeducation program within the last year
- Having a physical or mental problem t
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 |
|---|---|---|
| Watson Human Caring Model-based psychoeducationIt is a psychoeducation program based on the Watson human care model, one of the theories of the nursing profession, that includes healing processes, and consists of sessions that address the hopelessness, death anxiety and care burden of individuals. | Other | experimental caregiver group |
Primary outcome
Metting-Encounter
Time frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
caregiver is informed about topics included in psychoeducation program and discussed in weekly. 1. Beck Hopelessness Scale (BHS) was used to determine the hopelessness. The items are answered as "Yes-No". Total score is between 0-20. As the score of the scale increases; interpreted as an increase in hopelessness in individuals. 2. Templer Death Anxiety (TDA)Scale was used to determine the death anxiety. The total score that can be obtained from the scale is between 0-15, and values of seven and above are interpreted as high death anxiety. The items are answered as "True-False". 3. The Caregiver Strain Index (CSI)was used to determine care burden. The items in the scale are answered as "Yes-No". The total score of the scale is between 0-13,the average score of the scale is seven and above; interpreted as the burden of care in individuals. After psychoeducation,our aims are decreasing levels of 1. For hopelessness, BHS used 2. death anxiety, TDA used 3. care burden, CSI used
Understanding palliative care
Time frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Explaining the meaning of palliative care with the patient's relatives, discussing the common symptoms in patients. data from the qualitative stage; It was obtained by using structured interview forms of the relatives of the patients in the experimental group during psychoeducation program based on. In the 2nd, 3rd, 5th,7th sessions of psychoeducation, six questions were asked about the hopelessness, death anxiety and care burden. In this session, "What is the meaning of giving care to the relatives of the patients in the structured interview form-1? How did the caregiving process affect you?" A qualitative interview was conducted by asking the question.
Caregiving Process
Time frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Meeting with the caregiver about the difficulties and gains of the caregiving process In this session, "Can you share your experiences about the difficulties of the caregiving process? Can you tell about your experiences that made you feel good during the caregiving process?" A qualitative interview was conducted by asking the question.
Hope- Sources of Hope
Time frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Interviewing the caregiver about the importance of hope in life
Developing Hope
Time frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Meeting with the patient's relatives about what can be done to improve hope. In this session, "Can you share your experiences about the concept of hope in the care process?", "You are here with your patient right now, you are helping him, what are your expectations for the next days?" A qualitative interview was conducted by asking the question.
Death- Death anxiety
Time frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Interviewing the concept of death with the patient's relatives, providing information on what can be done to cope with death anxiety while caring for a patient with a terminal diagnosis.
Meaning of Life
Time frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
Interviewing with the caregiver about the meaning of life. In this session, "Can you share with me your end-of-life experiences in the caregiving process according to your culture and belief?" A qualitative interview was conducted by asking the question.
Last session
Time frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.Data collection forms (Descriptive Characteristics Form, Beck Hopelessness Scale, Templer Death Anxiety Scale and Caregiver Strain Index) applied again for post test to all caregivers.
post test Beck Hopelessness Scale was used to determine the hopelessness levels of caregivers after psychoeducation. The scale has 20 items and these items are answered as "Yes-No". The total score is between 0-20. As the score of the scale increases; interpreted as an increase in hopelessness in individuals. Templer Death Anxiety Scale was used to determine the death anxiety of caregivers after psychoeducation The total score that can be obtained from the scale is between 0-15, and values of seven and above are interpreted as high death anxiety. The items in the scale are answered as "True-False". The Caregiver Strain Index was used to determine caregivers' burden of care after psychoeducation. items in the scale are answered as "Yes-No". The scale has no sub-dimensions. The scale's total score is between 0-13, and if the average score of the scale is seven and above; interpreted as the burden of care in individuals.
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 4 Dec 2023.
- Background: PubMed 31941486Best M, Leget C, Goodhead A, Paal P. An EAPC white paper on multi-disciplinary education for spiritual care in palliative care. BMC Palliat Care. 2020 Jan 15;19(1):9. doi: 10.1186/s12904-019-0508-4.
- Background: PubMed 35227246Valero-Cantero I, Casals C, Carrion-Velasco Y, Baron-Lopez FJ, Martinez-Valero FJ, Vazquez-Sanchez MA. The influence of symptom severity of palliative care patients on their family caregivers. BMC Palliat Care. 2022 Feb 28;21(1):27. doi: 10.1186/s12904-022-00918-3.
- Background: PubMed 33647035Del-Pino-Casado R, Priego-Cubero E, Lopez-Martinez C, Orgeta V. Subjective caregiver burden and anxiety in informal caregivers: A systematic review and meta-analysis. PLoS One. 2021 Mar 1;16(3):e0247143. doi: 10.1371/journal.pone.0247143. eCollection 2021.
- Background: PubMed 25773135Jors K, Seibel K, Bardenheuer H, Buchheidt D, Mayer-Steinacker R, Viehrig M, Xander C, Becker G. Education in End-of-Life Care: What Do Experienced Professionals Find Important? J Cancer Educ. 2016 Jun;31(2):272-8. doi: 10.1007/s13187-015-0811-6.
- Background: PubMed 32023152Alam S, Hannon B, Zimmermann C. Palliative Care for Family Caregivers. J Clin Oncol. 2020 Mar 20;38(9):926-936. doi: 10.1200/JCO.19.00018. Epub 2020 Feb 5.
- Background: PubMed 29431580Bischoff K, Yang E, Kojimoto G, Shepard Lopez N, Holland S, Calton B, Adkins SH, Cheng S, Miller BJ, Rabow MW. What We Do: Key Activities of an Outpatient Palliative Care Team at an Academic Cancer Center. J Palliat Med. 2018 Jul;21(7):999-1004. doi: 10.1089/jpm.2017.0441. Epub 2018 Feb 12.
- Background: PubMed 31795461Perpina-Galvan J, Orts-Beneito N, Fernandez-Alcantara M, Garcia-Sanjuan S, Garcia-Caro MP, Cabanero-Martinez MJ. Level of Burden and Health-Related Quality of Life in Caregivers of Palliative Care Patients. Int J Environ Res Public Health. 2019 Nov 29;16(23):4806. doi: 10.3390/ijerph16234806.
- Background: PubMed 32133663Nierop-van Baalen C, Grypdonck M, van Hecke A, Verhaeghe S. Associated factors of hope in cancer patients during treatment: A systematic literature review. J Adv Nurs. 2020 Jul;76(7):1520-1537. doi: 10.1111/jan.14344. Epub 2020 Mar 20.
- Background: PubMed 26809826Davis MP, Lagman R, Parala A, Patel C, Sanford T, Fielding F, Brumbaugh A, Gross J, Rao A, Majeed S, Shinde S, Rybicki LA. Hope, Symptoms, and Palliative Care. Am J Hosp Palliat Care. 2017 Apr;34(3):223-232. doi: 10.1177/1049909115627772. Epub 2016 Jul 10.
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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.
Bilge SOYASLAN, Master principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watson Human Caring Model-based psychoeducation in people with Support, Family, run by Ankara Medipol 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 2 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 4 Dec 2023. 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?
Metting-Encounter (time frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.). The study lists 8 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 NCT06154759, which also lists 9 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 4 Dec 2023.