A Clinical Study On The Role Of Homoeopathy In Treating Nasal Obstruction And Its Impact On Quality Of Sleep Among Paediatric Age Group
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pre and post treatment assessment will be based on PAEDIATRIC SLEEP QUESTIONIARE (PSQ) tool.
研究概览
简要总结
AIM:
To study the effectiveness of individualized homoeopathic medicine in managing sleep disturbance due to nasal obstructions and improving sleep quality of children.
BACKGROUND AND JUSTIFICATION:
Nasal obstruction is thought to be a major cause of sleep impairment. Typical sleep-related problems seen with nasal obstruction include snoring, sleep-disordered breathing and sleep apnea. The impact of nasal obstruction on quality of life is well studied, however its effects on sleep have been less well studied. This study aims to investigate sleep disturbances in paediatric patients with nasal obstructions using paediatric sleep questionnaires.
HYPOTHESIS:
NULL HYPOTHESIS:
Homoeopathic medicine is not effective in the management of sleep disturbance induced by Nasal obstruction.
ALTERNATIVE HYPOTHESIS:
Homoeopathic medicine is effective in the management of sleep disturbance induced by Nasal obstruction.
METHODOLOGY
A sample of 30 cases will be selected based on purposive sampling. With the patient consent, detailed case taking will be done. The patient will be assessed at baseline with the PAEDIATRIC SLEEP QUESSTIONIARE tool as pre assessment. After case taking, the totality of symptoms will be obtained through the analysis and evaluation of symptoms. With the help of proper repertorization and Homoeopathic Materia Medica, final selection of remedy will be done by Individualization. Then the Individualized Homoeopathic medicine will be prescribed with the proper dose, potency, and repetition of medicines according to the Homoeopathic principles. Follow up will be done 2 weeks once and every change in the quality of sleep will be assessed monthly once using on PAEDIATRIC SLEEP QUESSTIONIARE tool as post assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •School going children of age 5-14 years Children of both sexes.
- •The patients who are having nasal obstruction (NOSE), with sleep disturbance qualifying more than 0.33 Paediatric Sleep Quesstionare (PSQ) score.
排除标准
- •Patients below 5years and above 14 years of age.
- •Patients with other systemic illnesses or complications.
- •Patients suspected or confirmed structural abnormalities.
- •Patients with intellectual disability or global developmental delay.
结局指标
主要结局
Pre and post treatment assessment will be based on PAEDIATRIC SLEEP QUESTIONIARE (PSQ) tool.
时间窗: 6 month
10 – 30% = Mild improvement
时间窗: 6 month
35 – 70% = Moderate improvement
时间窗: 6 month
more than 75% = Marked improvement
时间窗: 6 month
Monthly follow up with improvement in sleep quality
时间窗: 6 month
次要结局
- The improvement in the quality of sleep among nasal obstruction in children is considered to indicate that Individualized Homoeopathic medicines are effective.(6 month)
研究者
Dr HAJEERA A
White Memorial Homoeo Medical College