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Completed

NCT Number: NCT05255874

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elife Kettaş Dölek

Mersin, 33110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Anxiety evaluated using the State Anxiety Scale

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

    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 outcomes

  1. Change systolic and diastolic blood pressure

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

    Before and after the procedure systolic and diastolic blood pressure will be measured.

  2. Change heart rate

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

    Before and after the procedure heart rate will be measured.

  3. Change respiratory rate

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

    Before and after the procedure respiratory rate will be measured.

  4. Change peripheral oxygen saturation

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

    Before and after the procedure peripheral oxygen saturation will be measured.

  5. Change serum cortisol level

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

    Before and after the procedure blood will be drawn for serum cortisol level.

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2022
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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