NCT06734104

Brief Summary

This study will be conducted as a randomized controlled trial with a parallel design to determine the impact of an interactive video developed for the care of surgical patients wearing anti-embolism stockings on nursing students' learning outcomes. The research hypotheses are as follows: H0a: There is no statistically significant difference in knowledge scores regarding anti-embolism stocking application between the intervention and control groups. H0b: There is no statistically significant difference in knowledge scores regarding anti-embolism stocking application over time. H0c: There is no statistically significant difference in skill scores regarding anti-embolism stocking application between the intervention and control groups. H0d: There is no statistically significant difference in skill scores regarding anti-embolism stocking application over time. H0e: There is no statistically significant difference in knowledge and skill scores regarding anti-embolism stocking application based on the interaction between group and time factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

December 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2024

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2024

Enrollment Period

7 days

First QC Date

December 11, 2024

Last Update Submit

December 20, 2025

Conditions

Keywords

anti-embolism stockinginteractive videonursing studentsnursing educationsurgical nursing

Outcome Measures

Primary Outcomes (2)

  • Knowledge level regarding perioperative anti-embolism stockings care

    Perioperative Anti-Embolism Stocking Care Knowledge Assessment Form consists of 18 multiple-choice questions. The researchers have developed the knowledge assessment questions regarding perioperative anti-embolism stockings care based on the literature. Each question has only one correct answer. Expert opinions were sought during the development of the knowledge assessment test to enhance content validity. The average item difficulty of the test was found to be 0.498. An ideal result would have an average item difficulty of 0.50. The average item discrimination index of the test was determined to be 0.431. A value higher than 0.35 indicates that the test has excellent discrimination power, meaning it is highly discriminative. The knowledge test will be scored on a scale of 100 points, with each correct answer worth 5.5 points. The minimum value is 0, and the maximum value is 99. A higher score indicates a better outcome.

    From enrollment to the end of intervention at 2 weeks

  • Skill level regarding perioperative anti-embolism stockings care

    Perioperative Anti-Embolism Stocking Application Skills Assessment Form consists of 22 items. This form was developed by the researchers based on the literature. Expert opinions were sought during the development of the Skill Assessment Form to enhance content validity. In item number eight, the steps of neurovascular assessment are divided into seven sub-steps, and in item number 21, the situations to be recorded in the observation form for anti-embolism stockings are divided into four sub-categories. If a student fails to perform a skill, they will receive a score of zero (0), and if performed correctly, they will receive a score of one (1). The lowest score a student can receive is 0, and the highest score is 31. A higher score indicates a better outcome.

    From enrollment to the end of intervention at 2 weeks

Secondary Outcomes (1)

  • The experimental group's opinions regarding the interactive video.

    After the intervention is completed

Study Arms (2)

Interactive Video Group

EXPERIMENTAL
Other: Interactive Video Education

Control : Non-Interactive Video Group

ACTIVE COMPARATOR
Other: Non-Interactive Video Education

Interventions

After participants are informed about the study, eligible individuals (based on inclusion and exclusion criteria) will be identified. From the students deemed eligible for the study group, 60 students will be selected using a simple random sampling method by an independent statistician. Informed consent will be obtained from the students who agree to participate in the study. Initially, a pre-test will be administered to the 60 selected students. After the pre-test, the 60 students will be randomly assigned to the experimental and active control groups using a simple randomization method. The researcher will provide the non-interactive video to the students in the active control group. After one week of watching the non-interactive video, a post-test will be administered to all students.

Control : Non-Interactive Video Group

After participants are informed about the study, eligible individuals (based on inclusion and exclusion criteria) will be identified. From the students deemed eligible for the study group, 60 students will be selected using a simple random sampling method by an independent statistician. Informed consent will be obtained from students who agree to participate in the study. Initially, a pre-test will be administered to the 60 selected students. Following the pre-test, the students will be randomly assigned to the experimental and active control groups using a simple randomization method. The researcher will provide the interactive video to the students in the experimental group. After one week of interactive video training for the experimental group, a post-test will be administered to all students.

Interactive Video Group

Eligibility Criteria

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

You may qualify if:

  • The student must own a smartphone, tablet, or laptop/desktop computer capable of downloading the video.
  • The student must have internet access.
  • The student must be willing to participate in the study voluntarily.

You may not qualify if:

  • Graduates of health vocational high schools.
  • Students who have failed the Surgical Diseases Nursing course.
  • Students who have not participated in any of the stages of the study.
  • Students who voluntarily decide to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Sciences

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In the study, the researchers will be aware of the groups to which the students are assigned in order to plan the study. Since the students in the experimental group will receive an interactive video and those in the active control group will receive a non-interactive video, the students will not know their group assignment, ensuring participant blinding. Therefore, the study is single-blinded. During the process of obtaining informed consent, students will be informed that both groups will receive education on the subject through video. Additionally, students' skills will be assessed by three experts in the field of nursing, independent of the researchers. The evaluators will not be informed about the students' group assignments, ensuring blinding for the evaluators. Blinding will also be maintained during data analysis and reporting. Data entries will be coded as "A" and "B" without specifying whether they belong to the experimental or control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study protocol describes a single-center, randomized controlled parallel-group single-blind experimental study (1:1) to be conducted with nursing students at a public university in a province of Turkey. The protocol has been prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. The sample will include 60 students, with 30 in the experimental group and 30 in the active control group. Data will be collected using the Student Demographic Characteristics Form, the Perioperative Anti-Embolism Stockings Care Knowledge Assessment Form, the Perioperative Anti-Embolism Stockings Application Skills Assessment Form, and the Interactive Video Evaluation Form, all of which were developed by the researchers based on the literature. The study will evaluate the impact of the interactive video developed for the care of surgical patients wearing anti-embolism stockings on the knowledge and skill levels of nursing students.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Student and Expert Nurse Esra Cantürk [ECanturk]

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 16, 2024

Study Start

December 13, 2024

Primary Completion

December 20, 2024

Study Completion

December 27, 2024

Last Updated

December 29, 2025

Record last verified: 2024-12

Locations