NCT06154759

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

June 21, 2023

Last Update Submit

November 23, 2023

Conditions

Keywords

HopelessnessDeath AnxietyBurden of CarePalliative carePsychiatric Nursing

Outcome Measures

Primary Outcomes (8)

  • Metting-Encounter

    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

    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.

    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.

    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

    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.

    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.

    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.

    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.

    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.

Study Arms (2)

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.

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.

Interventions

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.

experimental caregiver group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilge Dilek SOYASLAN

Keçiören, Ankara, 06170, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 31941486BACKGROUND
  • 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.

    PMID: 35227246BACKGROUND
  • 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.

    PMID: 33647035BACKGROUND
  • 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.

    PMID: 25773135BACKGROUND
  • 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.

    PMID: 32023152BACKGROUND
  • 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.

    PMID: 29431580BACKGROUND
  • 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.

    PMID: 31795461BACKGROUND
  • 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.

    PMID: 32133663BACKGROUND
  • 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.

    PMID: 26809826BACKGROUND

MeSH Terms

Conditions

Necrophobia

Study Officials

  • Bilge SOYASLAN, Master

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The caregivers did not know which group they were assigned to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 21, 2023

First Posted

December 4, 2023

Study Start

July 20, 2022

Primary Completion

February 27, 2023

Study Completion

March 3, 2023

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations