Effect of Chewing Gum on Interdialytic Weight Gain, Thirst, Dry Mouth and Intradialytic Symptoms in Hemodialysis Patients: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change From Baseline Intradialytic Weight Gain
研究概览
简要总结
The aim of this prospective randomized controlled study was to investigate the effects of chewing gum on interdialytic weight gain, thirst, dry mouth and intradialytic symptoms in hemodialysis patients.
详细描述
The prevalence of xerostomia varies high in patients with chronic hemodialysis (HD), and the decreased saliva flow rate due to various mechanisms is the main factor in its development. The significant decrease in saliva flow due to the atrophy and fibrosis of the salivary glands in HD patients is further affected by the restriction in fluid intake. The use of drugs such as antidepressants, antipsychotics, antihistamines, antihypertensives, aspirin, benzodiazepines, opioids and proton pump inhibitors also leads to hyposalivation and xerostomia. Thirst is common in chronic HD patients due to both volumetric and osmometric causes but the primary mechanism is osmometric. The osmolarity of the extracellular fluid increases with the dietary salt and the hypothalamus is stimulated by the shrinkage of the osmoreceptor cells, leading to the desire to ingest liquids. Volumetric thirst develops secondary to water and salt loss and the resultant stimulation of cardiac baroreceptors, with the cardiac return volume decreasing gradually towards the end of the HD session. Increased interdialytic weight in HD patients causes increased risk of death due to cerebrovascular events and cardiovascular diseases and leads to an increase in morbidity and mortality together with a deterioration of the patient's quality of life. Interdialytic weight gain (IWG) causes incompliance with fluid control as a result of the secondary excessive consumption of liquid and food and is an important condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •18 years of age or older
- •On maintenance hemodialysis three times per week for four hours per session
- •Receiving hemodialysis therapy for a least six moths at the time of the study
- •Able to communicate in Turkish
- •Willing to participate to the study
排除标准
- •18 years of age younger
- •Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis.
- •The patient who took chemotherapy and radiotherapy
- •Have salivary gland infection and dementia
- •Oral and / or dental diseases to prevent chewing gum
- •Unwilling to to participate to the study
研究组 & 干预措施
Chewing gum group
The patients will be asked to chew on a regular chewing gum for three months.
干预措施: Chewing Gum (Dietary Supplement)
Control group
The patients will not chewing gum during three months.
结局指标
主要结局
Change From Baseline Intradialytic Weight Gain
时间窗: up to 12 weeks
Interdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session
Change From Baseline Feeling of Thirst at Three Months
时间窗: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
It will be assessed three times at the end of the dialysis session with Visual Analogue. Thirst intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Thirst increases as the score increases. The high point describes bad outcome.
Change From Baseline Intradialytic Symptoms at Three Months
时间窗: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
It will be assessed with "Dialysis Symptom Index". Using this scoring system, the minimum possible total severity score was 0 if none of the 30 symptoms was present and the maximum potential. Score was 150 if all of the 30 symptoms were reported and rated as "very much bothersome". The minimum value is "0" and the maximum value is "150".
Change From Baseline Dry Mouth at Three Months
时间窗: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
It will be assessed two times at the end of the dialysis session with sample of saliva. Saliva flow rate/minute will be measured. Saliva flow rate/minute is presented with "ml".
Change From Baseline Dry Mouth at Three Months
时间窗: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
It will be assessed three times at the end of the dialysis session with Visual Analogue Scale. Visual Analogue Scale ranging from 0 (no dry mouth) to 10 (worst dry mouth). Dry mouth increases the score increases. The high point describes bad outcome.
次要结局
- Change From Baseline Anxiety at Three Months(At the end of the 1st and 12th week (3 hemodialysis sessions are done every week))
- Change From Baseline Fluid Control at Three Months(At the end of the 1st and 12th week (3 hemodialysis sessions are done every week))
- Change From Baseline Depression at Three Months(At the end of the 1st and 12th week (3 hemodialysis sessions are done every week))
研究者
Nurten Ozen
Assistant Professor
Istanbul Demiroglu Bilim University