Children Recovering From Tonsil Surgery Following Day Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 576
- 试验地点
- 2
- 主要终点
- Sore throat item, in the instrument Postoperative Recovery in Children instrument (PRiC), change assessed
研究概览
简要总结
Children recovering from tonsil surgery following day surgery Tonsil surgery - self-care and treatment - the TONIST-study The main objective of this study is to evaluate the effect and experience of acupuncture, acupressure, specially designed diet and telephone counselling on children's surgery-related symptoms, quality of life and costs during recovery after tonsillectomy (TE) or tonsillotomy (TT).
Early discharge from hospitals means that patients have to deal with much of the post-operative care during recovery process on their own or with the help of relatives. The recovery period may be a progressive process of physical weakness (1,2).
In Sweden, 14 000 tonsil surgeries per year are performed, about 50% children under 15 years because of obstruction, of TE, tonsillectomy, and TT, tonsillomy. Children's tonsil surgery following day surgery are in focus for this study. Both qualitative and quantitative methods will be used.
详细描述
The TONIST-study
Acronyms:
APU Acupuncture, APR Acupressure, CReDECI Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare, CG control group, IG intervention Group, PONV Postoperatively nausea and vomiting, PRiC Postoperative Recovery in Children, EQ5D EuroQol five dimensions' questionnaire
A pilot study will include evaluating the amount of issues in the instruments perceived possible to answer and/or the number of measurement points are reasonable.
Children's tonsil surgery following day surgery are in focus for this study. Children admitted for day surgery is monitored only a few hours after the surgery before going home when the parents must take the main responsibility for the care and monitoring during the recovery period (3). The present study design does not depend on the type of tonsil operation implemented, but the percentage advantage lodge will result in the description. Fifty percent of these surgical procedures are performed as day surgeries (4). The procedure causes a postoperative period of pain and risk of bleeding (5). The pain increases up to seven days after surgery, leading to problems with eating, drinking and sleeping (6). Children seem to receive too little analgesia and there seems to be a great need for postoperative information (7). Especially when the procedure is performed as day surgery the professional postoperative treatment at hospital is transferred to the patient to perform self-care. For the parents of young children, it could be a demanding task (8). Furthermore, the children's need of care could lead to loss of income since temporary parental benefit for care of the child will be necessary as well as absence from work and increased costs for the healthcare organization. Evidence-based interventions should constitute the basis for development of health care and post-operative interventions are often very complex, involving physical and emotional mechanisms. There is a gap in knowledge about effective interventions after tonsil surgery that could ease the self-care performed at home. In the proposed trials the investigators want to evaluate the effects of APU, APR, specially designed diet and extended telephone counselling on relieving common postoperative symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children, 2-19 years of age who undergo Tonsillectomy or Tonsillotomi be asked to participate.
排除标准
- •For children who have aversion, intolerance or allergy to ice cream or any of the ingredients in it the exclusion of the ice cream as a snack will be done.
结局指标
主要结局
Sore throat item, in the instrument Postoperative Recovery in Children instrument (PRiC), change assessed
时间窗: On the surgery day, Daily during the postoperative days 1-7 and during the 10:th, 14:th and the 21:th day
Sore throat measured with the PRiC, instrument. Sore throat with the opportunity to grade the answer Not at all, A little, alternatively Much or Very much. Estimates for the number of children who need to be included in the study is based on the distribution of responses to the question "sore throat" that is, a sore throat the last 24 hours from the questionnaire PRiC. The control group is assumed to respond to the same distribution as the children in Bramhagen et al (2016) and the children in the intervention group is assumed to have a positive shift in the distribution of answers.
次要结局
- Numerical Rating Scale, NRS (0-10) anxiety(Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2)
- Numerical Rating Scale, NRS (0-10) Nausea(Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2)
- Postoperative Recovery in Children, PRiC, Questionaire.(Daily during the postoperative days 1-7 and during the 10:th, 14:th and the 21:th day)
- EQ5D Economic effect between, assessment of change(On the 14:th day before surgery, Daily during the 10:th, 14:th and the 21:th postoperative days)
- Protocol and diary for telephone follow up, assessment of change(On the first postoperative day and on the 3:rd, 5:th och 10:th day postoperatively.)
- Diary for acupuncture and acupressure, assessment of change(On the surgery day and daily on the postoperative days 1 to at 10. Measurement to the high tenth day postoperatively depending on whether the child is using the APU and / or LFS for so long.)
- Diary for specially designed diet including ice Cream, assessment of change(As long as meals are consumed, daily, up to 10 days following surgery day.)
- Numerical Rating Scale, NRS (0-10)(Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2)
研究者
Helena Rosén, PhD
Principal investigator
Lund University