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

NCT ID: NCT05255874

Last Updated: 2023-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
statistician

Study Groups

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Aromatherapy Group

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.

Group Type EXPERIMENTAL

Aromatherapy

Intervention Type OTHER

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.

Standard of care

Routine treatment and care interventions will be applied to the patients included in the control group during the procedure. Patients in the control 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Elife Kettas Dolek

Urology Polyclinic Responsible Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GÜLAY ALTUN UĞRAŞ

Role: STUDY_DIRECTOR

MERSİN UNIVERSITY

Locations

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Elife Kettaş Dölek

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 33626029 (View on PubMed)

Other Identifiers

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MersınUnıver

Identifier Type: -

Identifier Source: org_study_id

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