Clinical trial NCT05255874: The Effect of Aromatherapy Applied to the Patients in the Urodynamic Procedure
Official title: The Effect of Aromatherapy Applied to the Patients in the Urodynamic Procedure on Anxiety and Serum Cortisol Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Aromatherapy
Urodynamic
Serum Cortisol
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety evaluated using the State Anxiety Scale
timeFrame: Change from Baseline (before implementation) and within 5 minutes after procedure
Secondary outcomes:
measure: Change systolic and diastolic blood pressure
timeFrame: Change from Baseline (before implementation) and within 5 minutes after procedure
measure: Change heart rate
timeFrame: Change from Baseline (before implementation) and within 5 minutes after procedure
measure: Change respiratory rate
timeFrame: Change from Baseline (before implementation) and within 5 minutes after procedure
measure: Change peripheral oxygen saturation
timeFrame: Change from Baseline (before implementation) and within 5 minutes after procedure
measure: Change serum cortisol level
timeFrame: Change from Baseline (before implementation) and within 5 minutes after procedure
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Elife Kettaş Dölek
Study officials:
affiliation: MERSİN UNIVERSITY
name: GÜLAY ALTUN UĞRAŞ
role: STUDY_DIRECTOR
References:
citation: Ozel BZ, Quevedo A, Jung C, Shirazi F, Dancz CE. Lavender Aromatherapy for Anxiety and Pain During Multichannel Urodynamics: A Randomized Controlled Pilot Trial. Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):654-658. doi: 10.1097/SPV.0000000000001032.