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临床试验/NCT07157501
NCT07157501已完成不适用

Effect of Using Aromatherapy Versus Acupressure on Pain Intensity and Sleep Pattern for Children Undergoing Abdominal Surgeries

Mansoura University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4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
100
试验地点
1
主要终点
Change in pain intensity as measured by the Word-Graphic Rating Scale (WGRS)

研究概览

简要总结

The study's aim is to examine the effect of using aromatherapy versus acupressure on pain intensity and sleep pattern for children undergoing abdominal surgeries.

详细描述

Abdominal surgery is defined as a broad term used for various surgical procedures around the abdominal region. These can be used to treat or diagnose medical conditions present in that area. The surgery can be performed on multiple sites like the small intestines, spleen, stomach, appendix, and rectum or colon . Abdominal surgery in children can involve various techniques that depend on the organs which require an operation, that divided into two types; laparotomy and laparoscopic surgeries .

Laparotomies are defined as major surgeries which need large incisions on the abdomen of the child. These procedures require close, carful management to avoid it's major complications that extend the time of recovery. On the other hand, laparoscopic surgeries are smaller incisions made significantly than Laparotomies, that make little scars, less blood loss, decreased pain after surgery, and faster recovery . The most common cases of laparotomies among pediatric patients are adhesive bowel obstruction, adhesiolysis, open reduction of intussusception and bowel resection. While the procedures of laparoscopic surgeries that are used in pediatric patients are appendectomy, cholecystectomy, liver biopsy, ovarian distortion and orchidopexy. Pain is the serious postoperative problem that may result from operations due to tissue damage caused by surgical incisions that occurs shortly after surgery. It leads to the production of cellular breakdown and inflammatory mediators which trigger the nerve ending and send messages through the dorsal horn to the brain. The end effect of this pain transmission neuronal activity is pain perception. More than 80% of children who undergo surgical procedures experience acute postoperative pain. About 30-43% of pediatric patients report moderate or severe pain on the first postoperative day . The next most prevalent post-operative problem is insomnia. Hospitalized children frequently experience sleep disorders for many reasons such as physical condition, medications, fear of death, light, environmental noise, unpleasant odors, foreign instruments, nursing interventions, invasive procedures, complications of disease, loss of privacy and staying away from family. About 40-60% of hospitalized children have sleep disturbance . The hospitalized children stay awake for a significant amount of time; they cannot benefit from the therapeutic effects of sleep. Inadequate and unsatisfactory sleep impedes healing process by having negative effects on the immune system, wound healing process, cause fatigue, anorexia, muscle atrophy, delayed recovery, affect cognitive functions of children and increasing their level of stress and anxiety as well as, impair children's mental and physical development by directly affecting protein synthesis, cell differentiation, and growth hormone secretion .

Postoperative pain and insomnia are associated with increased morbidity and dysfunction that can delay time to ambulation and prolong the hospital length of stay. When postsurgical pain and insomnia are not appropriately managed, they may develop into chronic postoperative pain and fatigue, which, in turn, may lead to dysfunction, disability, and depression, and be difficult to manage.

Pediatric nurses play an important role in managing postoperative pain and insomnia among pediatric patients. They spend most of their time with the child and are accountable for assessment, the administration of analgesics, monitoring and reporting the outcomes of the given treatments. Some nurses believe that pain and insomnia are expected outcomes of surgery, hence, there is no need to alleviate the postoperative pain and insomnia completely .

The use of Complementary Alternative Medicine (CAM) in pediatric populations is considerably increased, especially for pain, sleep disturbance and acute conditions. The main reasons for seeking CAM were: the wish of avoiding chronic use of drugs with their related side effects, the desire of an integrated approach, the reported inefficacy of conventional medicine, and a more suitable children disposition to CAM than to pharmacological compound .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children age 6 to 12 years of both sexes. Conscious and having a caretaker. No history of respiratory diseases or has problems with his sense of smell (for aromatherapy group).
  • •Children undergoing abdominal surgeries such as acute appendicitis, intestinal obstruction, Inguinal and umbilical hernia

排除标准

  • •Post-operative severe pain preventing children from participating in the study. Children who have chronic disease such as cardiac and renal disease. The existence of coagulation disorders, as well as skin diseases or skin burns in the pressure points where in acupressure could be applied (for acupressure group).

研究组 & 干预措施

Using aromatherapy for pain and sleep disturbance

Experimental

participants in this group received aromatherapy only for decreasing pain intensity and improving sleep quality for children after abdominal surgeries

干预措施: Aromatherapy inhaler (Other)

Acupressure for pain and sleep disturbances for children after abdominal surgery

Experimental

participants in this group received acupressure for decreasing pain and improving sleep quality after abdominal surgery

干预措施: Accupressure (Behavioral)

结局指标

主要结局

Change in pain intensity as measured by the Word-Graphic Rating Scale (WGRS)

时间窗: Baseline (pre-intervention), and 30 minutes post-intervention

Pain intensity will be assessed using the Word-Graphic Rating Scale (WGRS), a validated self-report scale for children aged 6-12 years. The scale includes descriptive words along a line, ranging from "No pain" to "Worst possible pain." Children point to the word that best describes their pain level. Scores range from 0 to 10, with higher scores indicating greater pain intensity. The change from baseline to post-intervention will be analyzed. Unit of Measure: Score on a 0-10 scale

Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)

时间窗: Baseline (pre-intervention) and at the morning of 2nd postoperative day and at the morning of 3rd postoperative day

Pittsburgh Sleep Quality Index: It is a self-report questionnaire that assessed sleep quality and sleep pattern. The scale consists of components such as subjective sleep quality, sleep latency, habitual sleep efficiency, sleep disturbance, day time dysfunction. This rating scale consists of 30 items based on the 5 components. The scale will be used for the pre and post-test. Scoring of answer is based on 4-point rating scale (0 -3). Never - 0, Occasionally - 1, Frequently - 2, Always - 3. Scoring system : Good quality of sleep 0-30. Fair quality of sleep 31-60. Poor quality of sleep61-90

次要结局

未报告次要终点

研究者

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

Asmaa Sabry Attia Hassan El malah

Dr

Mansoura University

研究点 (1)

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