Effect of Standardized Patient-Based Pain Management Program

NCT06709430 | Completed

• 1 other identifier: KutahyaHSU-NECİBE-DAĞCAN-0003
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

When the studies were examined, no educational study was found to examine the effect of the standardized patient-based pain management program on the pain attitudes, self-efficacy and beliefs of nursing students. Therefore, in our study, investigators aimed to examine the effect of the standardized patient-based pain management program on the pain attitudes, self-efficacy and beliefs of nursing students. It is thought that our study results will provide evidence on pain management in undergraduate nursing education and clinics and contribute to the improvement of patient care outcomes. In addition, it is anticipated that the results of the current study will provide guidance to nurse educators for the development of pain management in nursing education and for further studies on the subject.

Conditions

Pain

Keywords

pain; nursing student; Standardized Patient; Pain Management Program; Pain Attitudes; Self-Efficacy; Beliefs

Outcome Measures

Primary Outcomes (1)

• Pain Beliefs Scale mean score

  Pain Beliefs Scale has a total of 12 items covering pain beliefs. The scale has 8 "Organic Beliefs" and 4 "Psychological Beliefs" sub-dimensions. The items in the scale are rated using a Likert-type scoring system ranging from 1 to 6 (1-always, 2-almost always, 3-often, 4-sometimes, 5-rarely, 6-never). The total score for each sub-dimension is calculated by summing the scores from the items in that sub-dimension and dividing them by the number of items in that sub-dimension. There is no cut-off point for scale scores; an increase in the score from a sub-score of the scale indicates that pain beliefs related to that test are high, while a decrease in the score indicates that pain beliefs related to that test are low. The highest score that can be obtained from the organic and psychological beliefs sub-dimensions is 6, and the lowest score is 1.

  up to 15 weeks

Secondary Outcomes (2)

• Attitudes mean score

  up to 15 weeks

• Self-Efficacy mean score

  up to 15 weeks

Study Arms (2)

Standardized Patient Group

EXPERIMENTAL

Students will be divided into standardized patient group and control groups. Theoretical courses, standardized patient-based pain management laboratory practice, and clinical practice processes will be applied to students in the experimental group.

Other: Standardized Patient Group

Classical education group

OTHER

Theoretical courses, case-based pain management laboratory practice, and clinical practice processes will be applied to students in the control group.

Other: Classical education group

Interventions

Classical education group OTHER

Students will be divided into standardized patient and Classical education group. Theoretical courses, standardized patient-based pain management laboratory practice, and clinical practice processes will be applied to students in the experimental group.

Classical education group

Standardized Patient Group OTHER

Students will be divided into standardized patient group and control groups. Theoretical courses, standardized patient-based pain management laboratory practice, and clinical practice processes will be applied to students in the

Standardized Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be a 2nd year student in the Department of Nursing
• To be registered in the Basic Principles and Practices in Nursing Course

You may not qualify if:

• Nursing students who did not volunteer to participate in the study,
• Having received training on pain before,
• Not participating in regular theoretical, laboratory and clinical internships during the academic period,
• Having worked or are working as a health worker

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Necibe

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Şenay TAKMAK, PhD

  Kütahya Health Sciences University, Faculty of Health Sciences

  STUDY DIRECTOR

• Burcu NAL, PhD

  Kütahya Health Sciences University, Faculty of Health Sciences

  STUDY DIRECTOR

• Ferzan KALAYCI EMEK, PhD (c)

  Kütahya Health Sciences University, Faculty of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Students will be randomly assigned (using online randomization software) to standardized patients group and control groups. Students will know that they are participating in the study and the interventions that will be applied to them, but they will be blinded as they will not know which group they are in. Due to the nature of the study, standardized patient and routine laboratory practices to be applied to the experimental and control groups will be applied by the first and second researchers. The research data will be collected by the third researcher who is blinded to the groups. In the statistical analysis of the data, the groups will be labeled as group 1 and group 2, and the fourth researcher will be blinded when evaluating the results. Thus, the 3rd and 4th researchers will be blinded to the study groups. In order to avoid bias in the evaluation of the results, the first and second researchers who are not blinded will not participate in any stage of the evaluation process.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Model Details: Theoretical courses, standardized patient-based pain management laboratory practice, and clinical practice processes will be applied to students in the experimental group.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 29, 2024
• Study Start: November 25, 2024
• Primary Completion: November 30, 2024
• Study Completion: March 1, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)