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The Effect of Aromatherapy Applied to the Patients in the Urodynamic Procedure

The Effect of Aromatherapy Applied to the Patients in the Urodynamic Procedure on Anxiety and Serum Cortisol Levels

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05255874
Enrollment
98
Registered
2022-02-25
Start date
2022-01-01
Completion date
2022-07-30
Last updated
2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Anxiety, Aromatherapy, Urodynamic, Serum Cortisol

Brief summary

This randomized controlled study is planned to determine the effect of aromatherapy applied to patients in the urodynamic procedure on patients' anxiety and serum cortisol levels. This study assumes that lavender inhalation in aromatherapy has positive effects on physiological parameters such as blood pressure, heart rate, respiratory rate, serum cortisol level, as well as reducing stress and anxiety.

Detailed description

98 patients in each group will be included in the study (Aromatherapy group=49; Control group=49). In addition to the routine treatment and care practices of the unit, aromatherapy will be applied to the patients included in the study group. Aromatherapy application will be applied to all patients by the same researcher. Aromatherapy application will be started 5 minutes before the urodynamic procedure after the patient is taken to the urodynamics room and lavender essential oil will be used with a diffuser until the end of the procedure. Routine treatment and care interventions will be applied to the patients included in the control group during the procedure.

Interventions

OTHERAromatherapy

Patients in the study group will rest for 5 minutes before and after the urodynamics procedure. All patients will be asked to fill in the 'Spielberger State Anxiety Scale' before and after the urodynamic procedure. Before and after the procedure, blood pressure, heart rate, respiratory rate, peripheral oxygen saturation will be measured. Blood will be drawn for serum cortisol level. In addition to the routine treatment and care practices of the unit, aromatherapy will be applied to the patients included in the study group. Aromatherapy application will be applied to all patients by the same researcher. Aromatherapy application will be started 5 minutes before the urodynamic procedure after the patient is taken to the urodynamic room, and lavender essential oil (3 drops in 300 cc water for 5 cubic meters of room) will be used with a diffuser until the end of the procedure.

Sponsors

Mersin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

statistician

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Those who signed the 'Informed Voluntary Consent Form' to participate in the research, * 18 years and older, * Conscious, oriented and cooperative, * Able to communicate * Urodynamic procedure applied, * No problem in sense of smell, * No chronic respiratory disease (lung cancer, chronic obstructive pulmonary disease, asthma, chronic bronchitis, etc.), * No history of dermatitis against cosmetic odor, * Patients without a known history of allergy to the essential oil used

Exclusion criteria

* Those who did not sign the Informed Consent Form to participate in the research, * Under 18 years of age, * Unconscious, without orientation and cooperation, * Unable to communicate, * Urodynamic procedure is not applied. * Having problems with the sense of smell, * Having chronic respiratory disease (lung cancer, chronic obstructive pulmonary disease, asthma, chronic bronchitis, etc.), * Having a history of dermatitis against cosmetic odor, * Having a trait anxiety scale score of 60 and above, * Patients with a known history of allergy to the essential oil used

Design outcomes

Primary

MeasureTime frameDescription
Anxiety evaluated using the State Anxiety ScaleChange from Baseline (before implementation) and within 5 minutes after procedureScores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high

Secondary

MeasureTime frameDescription
Change systolic and diastolic blood pressureChange from Baseline (before implementation) and within 5 minutes after procedureBefore and after the procedure systolic and diastolic blood pressure will be measured.
Change heart rateChange from Baseline (before implementation) and within 5 minutes after procedureBefore and after the procedure heart rate will be measured.
Change respiratory rateChange from Baseline (before implementation) and within 5 minutes after procedureBefore and after the procedure respiratory rate will be measured.
Change peripheral oxygen saturationChange from Baseline (before implementation) and within 5 minutes after procedureBefore and after the procedure peripheral oxygen saturation will be measured.
Change serum cortisol levelChange from Baseline (before implementation) and within 5 minutes after procedureBefore and after the procedure blood will be drawn for serum cortisol level.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026