NCT06837740

Brief Summary

Appropriate intervention methods should be investigated to reduce stress and fatigue of students in psychomotor skills. The aim of this study is to reveal the effects of music therapy and aromatherapy interventions on pulse, blood pressure, anxiety and self-esteem levels of nursing students during injection application to the ventrogluteal region on a mannequin. Hypotheses: H1a= During the ventrogluteal injection application of nursing students on a mannequin, Aromatherapy and Music therapy and Aromatherapy application have an effect on pulse rate. H1b= During the ventrogluteal injection application of nursing students on a mannequin, Aromatherapy and Music therapy and Aromatherapy application have an effect on blood pressure level. H1c= During the ventrogluteal injection application of nursing students on a mannequin, Aromatherapy and Music therapy and Aromatherapy application have an effect on anxiety level. H1d= During the ventrogluteal injection application of nursing students on a mannequin, Aromatherapy and Music therapy and Aromatherapy application have an effect on self-esteem level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

February 5, 2025

Last Update Submit

May 29, 2025

Conditions

Keywords

Pulse RateBlood PressureAnxietySelf-Esteem

Outcome Measures

Primary Outcomes (4)

  • Pulse Rate

    Pulse Rate

    "Average of 1 year"

  • Systolic and Diastolic Pressure

    Systolic and Diastolic Pressure

    "Average of 1 year"

  • Anxiety

    State Anxiety Inventory: It has also been translated and adapted into Turkish by Oner and Le Compte. It is a measurement tool consisting of statements indicating how a person feels at a certain moment.

    "Average of 1 year"

  • Self-Esteem

    Rosenberg Self-Esteem Scale Form: The scale, developed by Rosenberg to measure self-esteem, was adapted into Turkish by Çuhadaroğlu.

    "Average of 1 year"

Study Arms (3)

Aromatherapy group

EXPERIMENTAL

Experimental

Other: Aromatherapy group

Aromatherapy with music therapy group

ACTIVE COMPARATOR

Active comparator

Other: Aromatherapy with music therapy group

Control group

NO INTERVENTION

No intervention

Interventions

Effects of Aromatherapy Interventions

Aromatherapy group

Effects of Music Therapy and Aromatherapy Interventions

Aromatherapy with music therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Students who are first year students, and
  • Volunteer to participate in the research will be included.

You may not qualify if:

  • Volunteer to participate in the research will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

a university in eastern Turkey

Batman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hediye Utli, PhD

    Mardin Artuklu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Aromatherapy group Aromatherapy with music therapy group Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hediye Utli, PhD, RN, Assistant Professor

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 20, 2025

Study Start

February 28, 2025

Primary Completion

April 1, 2025

Study Completion

May 10, 2025

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations