THE EFFECT OF AROMATHERAPY AND REFLEXOLOGY ON PAIN, SLEEP QUALITY, AND SATISFACTION IN CHILDREN WITH CEREBRAL PALSY: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain Level
研究概览
简要总结
This randomized controlled trial was conducted to evaluate the effects of aromatherapy and foot reflexology on pain, sleep quality, and parental satisfaction in children with cerebral palsy. Cerebral palsy is a non-progressive neurodevelopmental disorder often associated with chronic pain and sleep disturbances, which negatively affect both children and their caregivers.
A total of 90 children aged 6-12 years with a confirmed diagnosis of cerebral palsy were randomly assigned to three groups: aromatherapy, reflexology, and control. The aromatherapy group received lavender oil massage applied to the feet, while the reflexology group received targeted pressure to specific reflex points on the feet. The control group did not receive any intervention. Interventions were applied over a defined period, and outcomes were measured before and after the intervention.
Pain levels, sleep quality, and parental satisfaction were assessed using validated measurement tools. The findings of this study aim to provide evidence on the effectiveness of non-invasive complementary therapies in improving clinical and caregiving outcomes in children with cerebral palsy.
详细描述
Cerebral palsy (CP) is one of the most common causes of motor disability in childhood and is frequently accompanied by secondary complications such as chronic pain and sleep disturbances. These problems significantly affect the quality of life of both children and their caregivers. Managing these symptoms is essential for improving overall well-being and enhancing care outcomes.
Complementary and alternative therapies, such as aromatherapy and reflexology, have gained increasing attention in pediatric rehabilitation due to their non-invasive, low-cost, and easy-to-apply nature. Aromatherapy involves the use of essential oils, such as lavender oil, which are known for their analgesic, sedative, and anxiolytic properties. Reflexology is a manual therapy that applies pressure to specific points on the feet believed to correspond to different body systems, promoting relaxation and physiological balance.
This study was designed as a pretest-posttest randomized controlled trial. The study population consisted of children aged 6-12 years diagnosed with cerebral palsy and their primary caregivers. Participants were recruited from special education and rehabilitation centers affiliated with provincial education authorities. A total of 90 participants were randomly assigned into three groups: aromatherapy (n=30), reflexology (n=30), and control (n=30).
In the aromatherapy group, lavender oil was applied through foot massage. In the reflexology group, pressure was applied to specific reflex points on the soles of the feet. The control group did not receive any intervention. All interventions were implemented according to a structured protocol over a defined period.
Data were collected using a Personal Information Form, the Wong-Baker FACES Pain Rating Scale, the Children's Sleep Habits Questionnaire, and the Newcastle Satisfaction with Nursing Care Scale. Measurements were conducted before and after the intervention period.
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
This study was conducted as an open-label trial. Due to the nature of the interventions (aromatherapy and reflexology), blinding of participants and care providers was not feasible.
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 diagnosed with cerebral palsy by a specialist physician
- •Aged 6 to 12 years
- •Having pain complaints or being suitable for pain assessment
- •Having sleep problems or being suitable for sleep quality evaluation
- •Parents willing to participate and providing written informed consent
- •No health condition or history of allergic reactions preventing participation in aromatherapy or reflexology
- •Ability to regularly participate in the intervention sessions
排除标准
- •Known allergic reaction to essential oils used in aromatherapy
- •Presence of skin integrity issues, infection, or orthopedic problems preventing reflexology
- •Significant neurological changes during the study period, such as increased seizure frequency
- •Inability to regularly attend intervention sessions or withdrawal from the study
- •Incomplete or incorrectly filled data collection forms
- •Voluntary withdrawal of the child or parent from the study
- •Initiation of another complementary therapy or pharmacological change that may affect study outcomes
研究组 & 干预措施
Reflexology Group
Participants in this group received foot reflexology, which involved applying manual pressure to specific reflex points on the soles of the feet. The intervention was implemented according to a structured protocol throughout the study period to reduce pain, improve sleep quality, and increase parental satisfaction in children with cerebral palsy.
干预措施: Reflexology (Other)
Aromatherapy Group
Participants in this group received aromatherapy intervention using lavender essential oil applied through foot massage. The intervention was administered according to a structured protocol over the study period. The aim was to reduce pain, improve sleep quality, and increase parental satisfaction in children with cerebral palsy.
干预措施: Aromatherapy (Other)
Control Group
Participants in this group did not receive any intervention during the study period. They continued with their usual care and were assessed using the same outcome measures as the intervention groups.
结局指标
主要结局
Pain Level
时间窗: Baseline and 4 weeks after intervention
Pain levels were assessed using the Wong-Baker FACES Pain Rating Scale, a validated tool ranging from 0 to 10. A score of 0 indicates no pain, and a score of 10 indicates the worst possible pain. Higher scores indicate greater pain severity.
Sleep Quality
时间窗: Baseline and 4 weeks after intervention
Sleep quality was evaluated using the Children's Sleep Habits Questionnaire (CSHQ). The total score ranges from 33 to 99, with higher scores indicating poorer sleep quality.
次要结局
- Parental Satisfaction(After 4 weeks of intervention)
研究者
Samet Koltaş
Lecturer (PhD)
Hakkari Universitesi