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临床试验/NCT06727526
NCT06727526尚未招募不适用

The Effect of Acupressure on Pain and Physiological Parameters in Infants Before and After Cardiac Catheterization: a Randomized Placebo Controlled Trial

Baskent University0 个研究点目标入组 35 人开始时间: 2024年12月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
35
主要终点
Pain

研究概览

简要总结

Acupressure, one of the traditional Chinese medicine practices dating back approximately 5,000 years, is a mind-body technique that can be independently applied by nurses. This practice involves applying pressure to specific points on the body to reduce pain. The pressure stimulates the release of substances such as endorphins, acetylcholine, norepinephrine, and dopamine, resulting in muscle relaxation, regulated blood circulation, and blocked pain signals at nerve endings, effectively reducing the sensation of pain. The aim of acupressure is to alleviate patient discomfort and improve quality of life by reducing the need for analgesics. Acupressure, which falls under the category of therapeutic massage, can be applied using the fingers and palms. According to its core philosophy, illness arises when the balance of energy flowing through body channels, called "meridians," is disrupted. Because acupressure does not involve needles, it is a safe, effective, and economical technique that is easy to learn and apply. The World Health Organization (WHO) classifies acupressure as a supportive treatment within its list of "treatable conditions." The technique involves applying pressure to the same point for 2-5 minutes. Stimulating specific points promotes the release of cytokines, such as endorphins, which play a role in pain reduction by blocking certain receptors on sensory nerve endings and thus preventing pain perception. Additionally, stimulating acupoints helps establish sympathetic and parasympathetic balance, supporting healthy homeostasis. Studies in the literature have investigated acupressure's positive effects on children's preoperative anxiety, postoperative pain severity, chemotherapy side effects, fatigue, sleep quality, asthma symptoms, and physical stress. In a study examining the impact of acupressure on procedural pain in infants prior to parenteral vaccinations, infants who received acupressure experienced lower pain levels and shorter crying durations. Similarly, a study investigating the effect of acupressure on acute pain during venous catheter insertion in children found that pain severity was lower among children who received acupressure. A systematic review examining the effects of acupressure on child health determined that acupressure is effective in alleviating procedural pain in children. The review emphasized that nurses should incorporate acupressure, a non-pharmacological method, into care practices for effective pain management in children. Despite evidence in the literature supporting acupressure's positive effects on pediatric health, no study has specifically examined its impact on pain and physiological parameters in children undergoing cardiac catheterization. Therefore, this thesis aims to investigate the effects of acupressure, applied before and after cardiac catheterization, on pain levels and physiological parameters in infants.

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 (Outcomes Assessor)

入排标准

年龄范围
1 Month 至 12 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infants between 1 month and 12 months
  • •Infants with congenital heart disease
  • •Infants undergoing cardiac catheterization for the first time
  • •Infants undergoing planned cardiac catheterization
  • •Infants without acupressure experience
  • •Infants whose parents volunteered to participate in the study

排除标准

  • •Infants with complications during catheterization
  • •Infants followed up in the intensive care unit after catheterization
  • •Infants with any deformity or lesion in the acupressure area
  • •Infants who have not received analgesics after catheterization
  • •Infants who were not given analgesics within six hours before catheterization
  • •Infants with neurodevelopmental disorders
  • •Infants whose parents did not volunteer to participate in the study

研究组 & 干预措施

Acupressure Group

Experimental

Infants in this group will undergo acupressure both before and after cardiac catheterization. The initial session will be administered by the researcher 30 minutes prior to the procedure. Acupressure will target three specific points: the seventh point of the heart meridian (HT7), the fourth point of the large intestine meridian (LI4), and the sixth point of the pericardial meridian (PC6). The areas will be warmed for approximately 20 seconds to minimize tissue sensitivity, avoiding direct pressure on the acupressure points. Each point will receive 12 minutes of treatment, comprising 10 seconds of compression followed by 2 seconds of relaxation, applied symmetrically. After this initial session, the infant will undergo cardiac catheterization. Upon return to the ward post-catheterization, a second acupressure session will be conducted one hour after the administration of the final dose of ketamine hydrochloride.

干预措施: Acupressure (Other)

Plasebo

Placebo Comparator

Infants in this group will receive placebo acupressure before and after cardiac catheterization. The initial session will be administered 30 minutes before the procedure, targeting areas approximately 1-1.5 cm away from HT7, LI4, and PC6 points, where meridians do not pass. The areas will be warmed for 20 seconds to minimize tissue sensitivity, avoiding direct pressure on acupressure points. Each site will receive 12 minutes of treatment, alternating 10 seconds of compression and 2 seconds of relaxation, applied symmetrically. Post-catheterization, a second placebo session will be conducted an hour after the last dose of ketamine hydrochloride.

干预措施: Placebo acupressure (Other)

Control Group

No Intervention

Infants in this group will not receive any specific intervention and will be provided routine care in the ward.

结局指标

主要结局

Pain

时间窗: 30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure

The Face, Legs, Activity, Cry, Consolability (FLACC) scale will assess the pain. The FLACC scale is a measurement used to assess pain for children between the ages of 1 month and 7 years or individuals who are unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain. As the score increases, the patient's pain increases.

次要结局

  • Saturation(30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure)
  • Heart Rate(30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure)

研究者

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

Ilcim Ercan Koyuncu

Principal Investigator

Istanbul University - Cerrahpasa

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