NCT07087470

Brief Summary

The aim of this study was to reveal the effect of simulation-based experience-based psychosocial care skills development programme on psychosocial care skills competence and professional quality of life of nurses working with oncology patients. The hypotheses of the study will be tested in accordance with the following guidelines. Hypothesis 1 The post-training psychosocial care competency levels of the nurses who underwent simulation-based psychosocial care skills development programme (SDPBSP) are higher than the group who underwent standard psychosocial care skills training (SPBBE). Hypothesis 2 The post-training compassion fatigue levels of the nurses who underwent the SDPBI development programme were lower than the SPBBE group. Hypothesis 3 The post-training burnout score levels of the nurses who underwent SPBBE development programme were lower than the group who underwent standard SPBBE. Hypothesis 4 The post-training compassion satisfaction levels of the nurses who underwent SPBBE development programme are higher than the group who underwent standard SPBBE. Hypothesis 5 The psychosocial care competency levels of the nurses who underwent SPBBE development programme at the 1-month post-training follow-up were higher than those who did not receive SPBBE training. Hypothesis 6 At the 1-month follow-up after the training, the compassion fatigue levels of the nurses who underwent SPBBE development programme were lower than the group who underwent SPBBE and did not receive training. Hypothesis 7 In the 1-month follow-up after the training, the mean burnout scores of the nurses who underwent SPBBE development programme were lower than those of the group who underwent SPBBE and did not receive training. Hypothesis 8 In the 1-month follow-up after the training, the mean compassion satisfaction scores of the nurses who underwent the SPBBE development programme were higher than the SPBBE training and non-training groups. Hypothesis 9 After the SDPBE programme, the psychosocial skills training scores of those who received SDPBE are higher than those who did not receive training. Hypothesis 10 At the 1-month follow-up after the SDPBE programme, the psychosocial skills training scores of those who received SDPBE were higher than those who did not receive training.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

May 1, 2025

Last Update Submit

July 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessment of nurses' psychosocial care competence

    Psychosocial Care Competence Self-Assessment Scale (PBYÖDÖ), is a tool that assesses the psychosocial care competence of nurses working in clinics and the extent to which staff focus on the psychosocial aspects of patients while providing treatment and care. The scale, whose validity and reliability were established by Karataş (2019), consists of 18 items and 4 factors (sub-dimensions). The first factor, "Symptom Diagnosis," includes statements 1, 2, 3, 4, and 5, which are related to symptom diagnosis, for a total of 5 items. The second factor, "Use of Information," includes statements 6, 7, 8, 9, and 10, which are related to the use of information and comprise a total of 5 items. The third factor, "Intervention," includes statements 11, 12, 13, and 14, which are related to the use of information and comprise a total of 4 items. The fourth factor, "Diagnosis," includes statements 15, 16, 17, and 18, which are related to diagnosis and cover a total of 4 items. Respondents ar

    T1: Baseline, T2: 1. Day, T3: 1 Months post- intervention

  • Evaluation of Student Satisfaction and Self-Confidence in Learning in Simulation Applications

    Student Satisfaction and Self-Confidence Scale in Learning: The psychometric measurements of the scale developed by Jeffries (2012) to assess student satisfaction and self-confidence and used in simulation-based education were conducted by Franklin et al. (2014). The Turkish validity and reliability study of the scale was conducted by Ünver et al. (2017). According to the Turkish adaptation of the scale for learning in a simulation environment, the total number of items is 12. The scale consists of two subheadings: "Satisfaction with Current Learning" and "Confidence in Learning." The "Satisfaction with Current Learning" subheading consists of five items, while the "Confidence in Learning" subheading consists of seven items. There are no negative items in the scale. A 5-point Likert scale with the following statements was used: 1) Strongly Disagree, 2) Disagree, 3) Undecided, 4) Agree, and 5) Strongly Agree. The Cronbach Alpha value for "Current Learning Satisfaction" is 0.85, and the

    T1: Baseline, T2: 1 day post education, TE: 1 Months post intervention

  • Assessment of nurses' professional quality of life

    Professional Quality of Life Scale (PYKÖ) was developed by Stamm (2005) and consists of the subdimensions of compassion satisfaction, compassion fatigue, and burnout. The Turkish adaptation of the scale was conducted by Yeşil et al. (2010) and consists of thirty items and three subscales. Compassion satisfaction (job satisfaction) is the first of the subscales and refers to the sense of satisfaction and contentment an employee feels as a result of helping another person in need in their profession or job. Items 3, 6, 12, 16, 18, 20, 22, 24, 27, and 30 on the scale measure job satisfaction (Min 0-Max 50). A high score on this subscale indicates increased satisfaction or fulfillment as a helper. The second subscale, burnout, is a test that measures feelings of exhaustion arising from difficulties in coping with problems in work life. Items 1, 4, 8, 10, 15, 17, 19, 21, 26, and 29 on the scale measure burnout (Min 0-Max 25). A high score on this subscale indicates a high level of burnout

    T1: Baseline, T2: 1 day post education, TE: 1 Months post intervention

Other Outcomes (1)

  • Evaluation of simulation design

    T1: Baseline, T2: 1 day post education, T3: 1 Months post intervention

Study Arms (3)

Group 1 Standart psychosocial care skills training

ACTIVE COMPARATOR

Nurses Receiving Simulation Based Training and classical psychosocial care skills training

Behavioral: Simulation-based education and classical education

Group 2

ACTIVE COMPARATOR

only the group that will receive training in classical psychosocial care skills

Behavioral: classical education

Group 3

NO INTERVENTION

No training will be given to any group

Interventions

Simulation-based psychosocial care skills training and classical psychosocial care skills training will be prepared for oncology nurses.

Group 1 Standart psychosocial care skills training

classical psychosocial care skills training will be prepared for oncology nurses.

Group 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • months or more experience of working with oncology patients
  • Not having received training on psychosocial care skills after graduation
  • Oncology nurses who volunteered to participate in the study

You may not qualify if:

  • Having less than 6 months of experience working with oncology patients
  • To have received training on psychosocial care skills after graduation
  • Not volunteering to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tülay Demiray

Istanbul, Turkey, 50506, Turkey (Türkiye)

NOT YET RECRUITING

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single participant
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

May 1, 2025

First Posted

July 28, 2025

Study Start

March 15, 2025

Primary Completion

November 10, 2025

Study Completion

November 30, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations