- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06154759
The Effect of Psychoeducation on Hopelessness, Death Anxiety and Caregiver Burden
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara
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Keçiören, Ankara, Turkey, 06170
- Bilge Dilek SOYASLAN
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: experimental caregiver group
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.
|
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.
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No Intervention: control caregiver group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
After psychoeducation,our aims are decreasing levels of
|
It will be applied once a week for 45-60 minutes for up to 8 weeks.
|
|
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. |
It will be applied once a week for 45-60 minutes for up to 8 weeks.
|
|
Caregiving Process
Time Frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
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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.
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It will be applied once a week for 45-60 minutes for up to 8 weeks.
|
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Hope- Sources of Hope
Time Frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
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Interviewing the caregiver about the importance of hope in life
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It will be applied once a week for 45-60 minutes for up to 8 weeks.
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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.
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It will be applied once a week for 45-60 minutes for up to 8 weeks.
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Death- Death anxiety
Time Frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
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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.
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It will be applied once a week for 45-60 minutes for up to 8 weeks.
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Meaning of Life
Time Frame: It will be applied once a week for 45-60 minutes for up to 8 weeks.
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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.
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It will be applied once a week for 45-60 minutes for up to 8 weeks.
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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.
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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. |
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bilge SOYASLAN, Master, lecturer
Publications and helpful links
General 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.
- Valero-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.
- Del-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.
- Jors 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.
- Alam 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.
- Bischoff 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.
- Perpina-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.
- Nierop-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.
- Davis 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.
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.306565
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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