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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05255874
• Other study ID #: MersinUniver
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: January 2023
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 30, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Aromatherapy
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.

Locations

Country	Name	City	State
Turkey	Elife Kettas Dölek	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety evaluated using the State Anxiety Scale	Scores 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	Change from Baseline (before implementation) and within 5 minutes after procedure
Secondary	Change systolic and diastolic blood pressure	Before and after the procedure systolic and diastolic blood pressure will be measured.	Change from Baseline (before implementation) and within 5 minutes after procedure
Secondary	Change heart rate	Before and after the procedure heart rate will be measured.	Change from Baseline (before implementation) and within 5 minutes after procedure
Secondary	Change respiratory rate	Before and after the procedure respiratory rate will be measured.	Change from Baseline (before implementation) and within 5 minutes after procedure
Secondary	Change peripheral oxygen saturation	Before and after the procedure peripheral oxygen saturation will be measured.	Change from Baseline (before implementation) and within 5 minutes after procedure
Secondary	Change serum cortisol level	Before and after the procedure blood will be drawn for serum cortisol level.	Change from Baseline (before implementation) and within 5 minutes after procedure