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

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aromatherapy
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Anxiety, Aromatherapy, Urodynamic, Serum Cortisol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Elife Kettaş Dölek

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aromatherapy Group

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change systolic and diastolic blood pressure
Before and after the procedure systolic and diastolic blood pressure will be measured.
Change heart rate
Before and after the procedure heart rate will be measured.
Change respiratory rate
Before and after the procedure respiratory rate will be measured.
Change peripheral oxygen saturation
Before and after the procedure peripheral oxygen saturation will be measured.
Change serum cortisol level
Before and after the procedure blood will be drawn for serum cortisol level.

Full Information

First Posted
February 14, 2022
Last Updated
January 19, 2023
Sponsor
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT05255874
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Aromatherapy, Urodynamic, Serum Cortisol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
statistician
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aromatherapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aromatherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety evaluated using the State Anxiety Scale
Description
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
Time Frame
Change from Baseline (before implementation) and within 5 minutes after procedure
Secondary Outcome Measure Information:
Title
Change systolic and diastolic blood pressure
Description
Before and after the procedure systolic and diastolic blood pressure will be measured.
Time Frame
Change from Baseline (before implementation) and within 5 minutes after procedure
Title
Change heart rate
Description
Before and after the procedure heart rate will be measured.
Time Frame
Change from Baseline (before implementation) and within 5 minutes after procedure
Title
Change respiratory rate
Description
Before and after the procedure respiratory rate will be measured.
Time Frame
Change from Baseline (before implementation) and within 5 minutes after procedure
Title
Change peripheral oxygen saturation
Description
Before and after the procedure peripheral oxygen saturation will be measured.
Time Frame
Change from Baseline (before implementation) and within 5 minutes after procedure
Title
Change serum cortisol level
Description
Before and after the procedure blood will be drawn for serum cortisol level.
Time Frame
Change from Baseline (before implementation) and within 5 minutes after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GÜLAY ALTUN UĞRAŞ
Organizational Affiliation
MERSİN UNIVERSITY
Official's Role
Study Director
Facility Information:
Facility Name
Elife Kettaş Dölek
City
Mersin
ZIP/Postal Code
33110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33626029
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.
Results Reference
result

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

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