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临床试验/NCT07514299
NCT07514299已完成不适用

Investigation of the Effects of Pre-Angiography Music Interview and Aromatherapy Application on Pain, Anxiety, Fear, and Comfort Levels in Cardiology Patients

Istanbul Aydın University1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2024年11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
发起方
入组人数
139
试验地点
1
主要终点
Patient Information Form

研究概览

简要总结

This study was conducted to examine the effects of non-pharmacological interventions applied before coronary angiography in cardiology patients. Specifically, the study focused on the use of music listening and lavender oil inhalation and their potential impact on patients' psychological and physical states prior to the procedure. The research was designed as a randomized controlled experimental study, in which participants were assigned to intervention and control groups for comparison.

Within the scope of the study, pain, anxiety, fear, and comfort levels were evaluated using standardized measurement tools, and data were collected through pre- and post-intervention assessments. The study emphasizes the importance of integrating complementary methods into clinical practice within a holistic nursing care approach.

Overall, the study aims to provide scientific evidence regarding the applicability of music therapy and aromatherapy as supportive, non-pharmacological interventions in the pre-angiography care of cardiology patients.

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)

入排标准

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

入选标准

  • No sedation before or during angiography
  • No diagnosed psychiatric disorder
  • Normal sense of smell
  • No allergy to essential oils used
  • Voluntary participation
  • Scheduled for angiography within 24 hours
  • Independent in activities of daily living
  • Literate (able to read and write)
  • No hearing impairment
  • Able to communicate effectively
  • No respiratory disease (e.g., asthma, COPD)
  • Not using non-pharmacological methods (e.g., yoga, reiki

排除标准

  • Communication problems
  • Psychiatric disorder diagnosis
  • Allergy to essential oils
  • Impaired sense of smell
  • Dislike or discomfort with lavender scent
  • Refusal to participate
  • Respiratory disease (e.g., asthma, COPD)
  • Peripheral vascular disease
  • Neurological disorder

研究组 & 干预措施

Experimental (Lavender) Group

Experimental

Patients in the aromatherapy group received lavender essential oil inhalation therapy, in which three drops of lavender oil were applied to a sterile sponge and held approximately 5 cm from the patient's nose for 5 minutes. This distance was maintained to ensure standardization of the intervention.

干预措施: Lavender essential oil inhalation (Other)

Experiment (Music) Group

Experimental

Patients in the music intervention group listened to relaxing classical music through headphones for 10 minutes in the waiting area before the angiography procedure.

干预措施: Music intervention (Other)

Control Group

Other

Participants in the control group received routine care without any additional intervention.

干预措施: routine care (Other)

结局指标

主要结局

Patient Information Form

时间窗: First day

The Patient Information Form was developed by the researchers based on an extensive review of the literature. The form included questions designed to collect information about the socio-demographic and clinical characteristics of the participants. The variables included in the form were age, gender, education level, marital status, place of residence, income level, smoking status, presence of chronic disease, previous angiography experience, and other relevant health-related information.

General Comfort Scale

时间窗: First day

The scale is designed based on a taxonomic structure that includes three levels and four dimensions forming the theoretical components of comfort, and is used to determine needs and to evaluate the extent to which comfort-providing nursing interventions lead to an increase in expected comfort. The scale is a four-point Likert type and contains a total of 48 items. The response patterns of the scale, which consists of positive and negative items, are given in a mixed order. Accordingly, a high score (4) in positive items indicates high comfort, and a low score (1) indicates low comfort. In the evaluation of the scale, the obtained negative scores are reverse-coded and added to the positive items. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.

General Comfort Scale

时间窗: Second day

The scale is designed based on a taxonomic structure that includes three levels and four dimensions forming the theoretical components of comfort, and is used to determine needs and to evaluate the extent to which comfort-providing nursing interventions lead to an increase in expected comfort. The scale is a four-point Likert type and contains a total of 48 items. The response patterns of the scale, which consists of positive and negative items, are given in a mixed order. Accordingly, a high score (4) in positive items indicates high comfort, and a low score (1) indicates low comfort. In the evaluation of the scale, the obtained negative scores are reverse-coded and added to the positive items. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.

Visual Analog Scale for Pain

时间窗: First day

The VAS, developed by Price et al. (1983), is commonly used in research to assess the intensity of pain as experienced by patients. It is a reliable and valid instrument. The scale consists of a 10-cm line, which can be either horizontal or vertical, with one end marked as "No Pain" (0) and the other as "Worst Pain" (10). Patients are given clear instructions on how to use the VAS and are asked to mark the point on the line that best represents their level of pain. The distance from the "No Pain" end to the patient's mark is then measured in centimeters and recorded. The scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain.

Visual Analog Scale for Pain

时间窗: Second day

The VAS, developed by Price et al. (1983), is commonly used in research to assess the intensity of pain as experienced by patients. It is a reliable and valid instrument. The scale consists of a 10-cm line, which can be either horizontal or vertical, with one end marked as "No Pain" (0) and the other as "Worst Pain" (10). Patients are given clear instructions on how to use the VAS and are asked to mark the point on the line that best represents their level of pain. The distance from the "No Pain" end to the patient's mark is then measured in centimeters and recorded. The scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain.

Visual Analog Scale for Fear

时间窗: First day

Fear levels were measured using a similar Visual Analog Scale, ranging from 0 to 10, where 0 indicates "no fear" and 10 represents "extreme fear". Participants were asked to mark the point on the scale that best represented their fear level before the angiography procedure.

Visual Analog Scale for Fear

时间窗: Second day

Fear levels were measured using a similar Visual Analog Scale, ranging from 0 to 10, where 0 indicates "no fear" and 10 represents "extreme fear". Participants were asked to mark the point on the scale that best represented their fear level before the angiography procedure.

Visual Analog Scale for Anxiety

时间窗: First day

Participants' anxiety levels were also measured using a Visual Analog Scale ranging from 0 (no anxiety) to 10 (extreme anxiety). The scale allows patients to subjectively evaluate the severity of their anxiety at the time of assessment.

Visual Analog Scale for Anxiety

时间窗: Second day

Participants' anxiety levels were also measured using a Visual Analog Scale ranging from 0 (no anxiety) to 10 (extreme anxiety). The scale allows patients to subjectively evaluate the severity of their anxiety at the time of assessment.

State-Trait Anxiety Inventory

时间窗: First day

The State Anxiety Scale is a highly sensitive tool for assessing rapidly changing emotional reactions. It provides information about an individual's operational anxiety. It is a four-point scale ranging from "none" to "completely." The Trait Anxiety Scale, on the other hand, requires the individual to describe how they generally feel. The State Anxiety Scale includes both direct and inverted statements. Direct statements indicate negative emotions, while inverted statements indicate positive emotions. The final value obtained is the individual's anxiety score. In interpreting the scores, the total score obtained from both inventories ranges from 20 to 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.

State-Trait Anxiety Inventory

时间窗: Second day

The State Anxiety Scale is a highly sensitive tool for assessing rapidly changing emotional reactions. It provides information about an individual's operational anxiety. It is a four-point scale ranging from "none" to "completely." The Trait Anxiety Scale, on the other hand, requires the individual to describe how they generally feel. The State Anxiety Scale includes both direct and inverted statements. Direct statements indicate negative emotions, while inverted statements indicate positive emotions. The final value obtained is the individual's anxiety score. In interpreting the scores, the total score obtained from both inventories ranges from 20 to 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.

次要结局

未报告次要终点

研究者

发起方
Istanbul Aydın University
申办方类型
Other
责任方
Principal Investigator
主要研究者

DİLEK YILDIRIM

Assoc. Prof. Dr.

Istanbul Aydın University

研究点 (1)

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