SYMPTOM MANAGEMENT EDUCATION GIVEN WITH MICRO TEACHING METHOD ENRICHED WITH STANDARD PATIENT IN PALLIATIVE CARE

April 24, 2023 updated by: Ankara Yildirim Beyazıt University

THE EFFECT OF SYMPTOM MANAGEMENT EDUCATION GIVEN WITH MICRO TEACHING METHOD ENRICHED WITH STANDARD PATIENT IN PALLIATIVE CARE ON NURSING STUDENTS' KNOWLEDGE LEVEL, REFLECTIVE THINKING LEVEL AND THERAPEUTIC COMMUNICATION SKILLS

The study was planned as a randomized controlled pre-test, post-test intervention study to determine the effect of symptom management training in palliative care given with micro-teaching method enriched with standard patient on nursing students' knowledge levels, reflective thinking levels and therapeutic communication skills related to palliative care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sample of study was calculated as 36 using G*Power Software (ver. 3.1.9.2) for 80% power and medium effect size (f=0.40) at 95% confidence level in line with the data of Lin et al. The experimental and control groups were planned as 20 students each with a 10 percent loss. Participants were assigned to the experimental and control groups by the stratified randomization method. The locks were assigned to layers using Microsoft Excel. A pre-test will be applied to both groups. The control group will receive palliative care brochure for patients and their relatives.The practice group will be shared the 4 most common symptoms in palliative care nursing: pain, fatigue, respiratory distress and loss of appetite. The practice group will be 5 groups and there will be 4 students in each group. During the practice, each student will provide patient education about only one symptom. The standard patient will participate in the intervention in the application laboratory and the students will participate in the intervention in the computer environment. Video recordings will be taken while the students are giving education. After watching the experts, peers and their own video with the micro-teaching group evaluation form, the student himself/herself will make an evaluation. At the same time, a lecturer from outside the research will fill in the Standard Patient Check-List Evaluation Form. The application will be repeated one week later. After all the applications, the students will watch the video of their own 2 more times and the post-test will be applied to both groups. After one month, a retention test will be applied to the students in both groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Mamak
      • Ankara, Mamak, Turkey
        • Recruiting
        • Esra Tayaz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Students taking palliative care course for the first time,
  • Students who agreed to participate in the study,

Exclusion Criteria:

  • Students who have already taken the palliative care course,
  • Students who answered the data collection forms incompletely,
  • Students who do not want to continue the research,
  • Students who missed even one of the theoretical or practical sessions of the study.
  • Students with experience of caring for a palliative care patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Micro-teaching enriched with standard patient will be applied.
Other: Micro-teaching enriched with standard patient
The practice group will be shared the 4 most common symptoms in palliative care nursing: pain, fatigue, respiratory distress and loss of appetite. The practice group will be 5 groups and there will be 4 students in each group. During the practice, each student will provide patient education about only one symptom. The standard patient will participate in the intervention in the application laboratory and the students will participate in the intervention in the computer environment. Video recordings will be taken while the students are giving education. After watching the experts, peers and their own video with the micro-teaching group evaluation form, the student himself/herself will make an evaluation. At the same time, a lecturer from outside the research will fill in the Standard Patient Check-List Evaluation Form. The application will be repeated one week later.
No Intervention: Control group
The control group will receive palliative care brochure for patients and their relatives.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
KNOWLEDGE LEVEL
Time Frame: 2 months
A knowledge test on symptom management and communication in palliative care was developed by the researcher. It consists of 25 questions.
2 months
REFLECTIVE THINKING LEVEL
Time Frame: 2 months
Scale for Determining the Level of Reflective Thinking will be used. It is a 16-item 5-point Likert-type scale consisting of four sub-dimensions. Its sub-dimensions are habituation, comprehension, reflection and critical reflection.
2 months
THERAPEUTIC COMMUNICATION SKILLS
Time Frame: 2 months
Therapeutic Communication Skills Scale for Nursing Students will be used. It is a 7-point Likert scale consisting of a total of 16 items, including 7 items in the NonTherapeutic Communication Skills sub-dimension, 6 items in the Therapeutic Communication Skills 1 sub-dimension, and 3 items in the Therapeutic Communication Skills 2 sub-dimension.
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Micro Teaching Group Evaluation Form
Time Frame: 2 weeks
It was created by the researcher. It will be used for self-assessment by experts, peers and the student during the implementation.
2 weeks
Standard Patient Evaluation Form
Time Frame: 2 weeks
Created by the researcher. It will be filled in by specialists during standardized patient practice.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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