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临床试验/NCT05255874
NCT05255874已完成不适用

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

Mersin University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Anxiety evaluated using the State Anxiety Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

statistician

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Aromatherapy (Other)

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.

结局指标

主要结局

Anxiety evaluated using the State Anxiety Scale

时间窗: 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

次要结局

  • Change systolic and diastolic blood pressure(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)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elife Kettas Dolek

Urology Polyclinic Responsible Nurse

Mersin University

研究点 (1)

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