The Effect of Tonsillectomy Diet Education on Bleeding and Pain After Adenotonsillectomy in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Follow-up and Evaluation Form for Children After Adenotonsillectomy
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of tonsillectomy diet education on postoperative bleeding and pain in children undergoing adenotonsillectomy. Seventy-six pediatric patients will be randomly assigned to either an intervention group, which will receive specific diet education prior to surgery, or a control group receiving standard care. Bleeding and pain will be assessed at 4, 8, and 24 hours, and on the 7th day after surgery using a specialized follow-up form and the Wong-Baker Faces Pain Rating Scale. The study hypothesizes that diet education will reduce postoperative bleeding and pain, improving recovery and quality of life in children.
详细描述
Problem Adenotonsillectomy, which means removal of adenoids and tonsils, is one of the most common surgical operations performed in children.The most common indications for tonsillectomy are sleep-disordered breathing, recurrent upper respiratory tract infections, sinusitis, tonsillitis and peritonsillar abscess. Nausea and vomiting, restricted oral intake, high fever, swallowing problems, bleeding and pain are common problems after adenotonsillectomy. Bleeding and pain in the tonsil bed especially after adenotonsillectomy negatively affect the healing process. It leads to a decrease in fluid and food intake and pain control may become difficult. Pain after adenotonsillectomy surgery is a complication that reduces quality of life and may require hospitalization. Pain decreases the quality of life of the child and caregivers after surgery, and children face the risk of decreased oral intake, dehydration due to lack of nutrition and hyperthermia. Another important problem after adenotonsillectomy is bleeding. Postoperative bleeding is one of the most common and serious complications.Bleeding complication may occur in the early or late period. Bleeding within the first 24 hours is classified as primary bleeding, while bleeding that occurs later is called secondary bleeding.It is suggested that primary bleeding is related to acute vascular injuries that occur during surgery, while secondary bleeding is related to fibrinolysis, which can be seen due to clot dissolution in previously coagulated foci as a result of various causes and surgical wound infection. Postoperative bleeding is graded as mild to moderate to severe bleeding according to findings indicating bleeding color and content such as pink, light red with clots, dark red without clots, dark red with clots, ground brown without clots, ground brown with clots in the incision area.A bleeding complication can lead to readmission to hospital after discharge from hospital. Patients admitted with bleeding complications may initially be followed up only with close clinical observation, but in more severe cases, they may require surgical intervention under local or general anesthesia due to bleeding.In addition, bleeding after adenotonsillectomy may rarely result in mortality. Bleeding is more common after adenotonsillectomy surgery as a result of non-compliance with the tonsillectomy diet and consumption of solid, hot, bitter and sour foods. In uncontrolled cases, it is known to cause bleeding that requires a second surgical operation and even fatal bleeding in more advanced cases. In this case, there are precautions to be taken before the complication occurs. These measures are the tonsillectomy diet that should be considered after adenotonsillectomy surgery. It is known that post-adenotonsillectomy bleeding causes psychological social distress and burden on the patient, the patient's relatives and the physician, as well as economic burden.
Method Research Model In this study, the effect of tonsillectomy diet training on bleeding and pain after adenotonsillectomy in children will be examined with a randomized controlled repeated measures design.
Population and Sample The population of the study will consist of children who underwent adenotonsillectomy surgery in the otolaryngology clinic of a public education and research hospital in a district of Istanbul between March and September 2025. In this study, a power analysis was conducted to determine the sample size. Power analysis was performed with G*Power 3.1.9.4 package program.The sample size of the study was calculated with reference to the study of M. Albeladi,2020 due to its similarity to the subject and method of this study, and as a result of the calculations, the effect size was calculated to be 0.95. Accordingly, for the two-tailed hypothesis to maximize the sample size; margin of error α: 0.28 effect size (∆:0.3 and Power: 0.95, the minimum number of children to be included in the study will be 38 children for each group, totaling 76 children.
Training Materials Content of the training manual (I Heal with Cold and Soft Foods) : In the study, the effect of tonsillectomy diet on bleeding and pain after adenotonsillectomy in children will be examined. A training manual will be prepared to ensure the compliance of the child or caregiver with the tonsillectomy diet. In the prepared training manual; general information about adenotonsillectomy surgery and its causes will be briefly explained. What the tonsillectomy diet is, what the diet includes and which foods are appropriate to consume after surgery will be explained. It will be explained which foods should be consumed on which day and which foods should be avoided (bitter, spicy, hard foods, etc.) with tonsillectomy diet. Experts will be consulted to determine the suitability of the content of the training manual to the developmental levels of children and the literature.
Training Power point presentation: Children in the research group and their caregivers will be trained in line with the content of the "Training manual" by using lecture and power point presentation methods. Power point presentation training will be given via computer. Before the training, the researcher will briefly introduce himself/herself in a sincere tone of voice to create a reassuring environment. Then he/she will explain the purpose, subject and duration of the research. The researcher will explain to the children and their caregivers that they can express their thoughts or ask questions about the subject during the training. The routine tonsillectomy diet training given routinely by the clinic nurse will be continued for the children and their caregivers in the control group.
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
- None
盲法说明
research and control group
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The child being sick,
- •The child will have an adenotonsillectomy,
- •The child has no milk allergy (to exclude children at risk of developing milk allergy during the data collection process),
- •The child's caregiver stays with the child during the research process (to avoid communication barriers and disruptions in treatment and care instructions during the training and data collection process),
- •The child and caregiver can speak and understand Turkish (to avoid communication barriers during the training and data collection process),
- •The child's caregiver agrees to the research,
- •Children without swallowing difficulties and aspiration risk (e.g. nasogastric catheter, tracheostomy)
- •Children without diseases that cause maladaptive behavior (e.g. autism, cerebral palsy)
排除标准
- •The child has a milk allergy,
- •Children with diseases that cause swallowing difficulties, risk of aspiration and maladaptive behavior (e.g. autism, cerebral palsy)
- •Failure of the child and caregiver to attend the follow-up examination on the 7th day after surgery
结局指标
主要结局
Follow-up and Evaluation Form for Children After Adenotonsillectomy
时间窗: 4th hour after surgery 1st assessment, 8th hour after surgery 2nd assessment, 24th hour after surgery 3rd assessment, 7th day after surgery 4th assessment. The first 3 assessments will be duri
The time and number of evaluations; 4th hour after surgery will be considered as 1st evaluation, 8th hour after surgery as 2nd evaluation, 24th hour after surgery as 3rd evaluation, 7th day after surgery as 4th evaluation. The first 3 evaluations will be during hospitalization. The next 7th day evaluation will be evaluated on the 7th day when the child and caregiver are discharged and come for follow-up.
次要结局
未报告次要终点
研究者
Behice Ekici
Associate Professor, PhD
Maltepe University
