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

NCT05255874 | Completed DMC

• 1 other identifier: MersınUnıver
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety; Aromatherapy; Urodynamic; Serum Cortisol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change systolic and diastolic blood pressure

  Change from Baseline (before implementation) and within 5 minutes after procedure

• Change heart rate

  Change from Baseline (before implementation) and within 5 minutes after procedure

• Change respiratory rate

  Change from Baseline (before implementation) and within 5 minutes after procedure

• Change peripheral oxygen saturation

  Change from Baseline (before implementation) and within 5 minutes after procedure

• Change serum cortisol level

  Change from Baseline (before implementation) and within 5 minutes after procedure

Study Arms (2)

Aromatherapy Group

EXPERIMENTAL

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.

Other: Aromatherapy

Standard of care

NO INTERVENTION

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.

Interventions

Aromatherapy 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.

Aromatherapy Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who signed the 'Informed Voluntary Consent Form' to participate in the research,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Elife Kettaş Dölek

Mersin, 33110, Turkey (Türkiye)

Location

Related 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.

  PMID: 33626029 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• GÜLAY ALTUN UĞRAŞ

  MERSİN UNIVERSITY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: statistician
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Polyclinic Responsible Nurse

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 25, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: July 30, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)