The Effect of Back Massage With Frankincense and Myrrh Oil Before the Cardiac Electrophysiological Procedure on Back Pain Intensity and Comfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
This study was conducted to determine the effect of back massage with 4% frankincense and myrrh oil on back pain severity and comfort in patients who will undergo cardiac electrophysiological study (EPS).
详细描述
The study was conducted as a randomized controlled study. The population of the research consists of individuals who will undergo cardiac EPS in the angio unit of a heart hospital at a university. The sample size was determined as 20 people per group and a total of 60 people for an effect size of 0.131 and a power of 90%. Considering that there may be sample losses, 10 more patients were taken per group, and the study was completed with 30 patients for each group, a total of 90 people.
Randomization: Patients who met the inclusion criteria; They were assigned to one of three groups: 1. Intervention group massaged with frankincense and myrrh oil, 2. Placebo group massaged with jojoba oil, and 3. Control group. In hospital routine, patient appointments for the EPS procedure are determined on a weekly basis. Since the operation day of the research doctor who will perform the EPS procedure is Monday; Since patient rooms are not single occupancy; In addition, groups were randomized computer according to weeks to prevent contamination of frankincense and myrrh oil used for massage in the intervention group to the placebo and control groups.
Data were collected with the Patient Information Form, which includes the sociodemographic and health history of the individuals, the Visual Analogue Scale (VAS) for pain severity assessment, and the General comfort questionary (GCQ) for comfort.
Individuals who met the inclusion criteria in the study were assigned to the 1st Intervention group, 2nd Placebo group, and 3rd Control group in accordance with randomization, with their informed consent. No intervention was made in the standard treatment applied in the clinic.
In a systematic review and meta-analysis study, it is reported that bed rest is recommended for patients at wide intervals from 2 hours to 24 hours (2,4,6,12 and 24 hours) to prevent vascular complications after cardiac catheterization.Therefore, in this study, post-procedure back pain and comfort assessment were checked at the 4th hour, which is the clinical ambulation routine.
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
- 否
入选标准
- •Individuals who are over 18 years old;
- •agreeing to participate in the study;
- •EPS planned from the femoral region;
- •no communication problems (hearing, vision, speech, perception problems);
- •According to VAS, there is no pain in any part of the body before the procedure;
- •individuals who did not develop any reaction 30 minutes after applying the oils to be used on the skin on the forearm were included in the study.
排除标准
- •Those who had an allergic skin reaction,
- •skin disease in the back region,
- •a history of fractures or surgical operations in the waist and back region in the last year,
- •those who had neurological disorders (hemiparesis, etc.),
- •those who received massage therapy in the last three months, those who were diagnosed with cancer,
- •those who suffered from acute myocardial infarction were excluded.
结局指标
主要结局
Visual Analog Scale
时间窗: four hours
It was used to evaluate the severity of back pain. The patient marks his or her own pain on a 10 cm ruler with painlessness (0) on one end and the most severe pain (10) on the other. The distance between the onset of "no pain" and this point marked by the patient is measured and recorded in centimeters. A high score indicates a high pain intensity.
General Comfort Questionary
时间窗: four hours
It was developed by Kolcaba in 1992. It was used to evaluate comfort. The scale is a four-point Likert type, positive and negative contains a total of 48 items. There are four sub-dimensions that physical, psychospiritual, environmental and sociocultural. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. The average value is determined by dividing the total score obtained by the number of scale items and the result is indicated in the 1-4 distribution. Low comfort is expressed by one and high comfort by four.
次要结局
未报告次要终点
研究者
ülkü özdemir
assistant professor doctor
TC Erciyes University