NCT05731921

Brief Summary

To investigate the effect of the exercise program with the 'Empathy Dress' applied to midwifery students on the Levels of physical discomfort, empathy and compassionate love in the midwifery department of Amasya University. A total of 62 midwifery student are planned to be included in the study. Data will be collected with the "Student Information Form", "The Toronto Empathy Questionnaire- TEQ", "Evaluation Scale for Physical Discomfort", and "The Compassionate Love Scale". In the study, an exercise program that includes a total of eight sessions of 'Empathy Dress' and some exercises, every week and 20 minutes per week to the midwifery students in the experimental group, by the researcher. It is thought that the results of the study will improve the empathy and sensitive love levels of midwifery students and increase the quality of midwifery care offered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 9, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

February 9, 2023

Last Update Submit

April 19, 2024

Conditions

Keywords

MidwiferyStudentEmpathy levelPhysical discomfort levelCompassionate Love level

Outcome Measures

Primary Outcomes (2)

  • Empathy Level

    Empathy is one of the primary outcomes. This will be measured using 'The Toronto Empathy Questionnaire- TEQ'. The minimum score that can be obtained from the scale is "13", the maximum score is "65", and as the score obtained from the scale increases, empathy levels also increase.

    2 months

  • Compassionate Love Level

    Compassionate Love Level is the other primary outcomes. This will be measured using 'The Compassionate Love Scale'. The minimum score that can be obtained from the scale is "21", the maximum score is "147", and as the score obtained from the scale increases, Compassionate Love levels also increase.

    2 months

Secondary Outcomes (1)

  • Physical Discomfort Level

    2 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The exercise program with the 'Empathy Dress'

Behavioral: The exercise program with the 'Empathy Dress'

Control group

NO INTERVENTION

No intervention

Interventions

The experimental group will be given an exercise program that includes a total of eight sessions (two months) of 'Empathy Dress' and some exercises (stairs going up and down, sitting up, putting on trousers, tying shoes, etc.), every week and 20 minutes per week, by the researchers.

Experimental group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMidwifery Students
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the study
  • Absence of a defined psychiatric disorder
  • There is no problem that prevents communication

You may not qualify if:

  • Those who have movement system problems that prevent them from exercising with increasing weights by adapting to their pregnancy weeks,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Amasya, 05000, Turkey (Türkiye)

Location

Study Officials

  • Emine İbici Akça, Ph.D

    Amasya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled trial with pretest-posttest control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr. in the Amasya University Midwifery Department

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 16, 2023

Study Start

February 15, 2023

Primary Completion

April 30, 2023

Study Completion

February 1, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations