Intervention to Improve Sleep Quality in Caregivers of Palliative Care Patients in the Community: Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline sleep interruption level (number of awakenings and wakefulness after the onset of sleep) at 7 days by accelerometry
研究概览
简要总结
Introduction Sleeping problems experienced by cancer patients carers are frequent with 72% of carers reporting moderate to severe problems. Another consequence for this carers is the increase of suffering from depression and it is usually associated to carer overload.
Objectives
Main objective:
- To evaluate the effects of listening to music in sleep quality for oncology patients non-professional carers at home, and to evaluate the influence of specific factors that may modify that effect.
Secondary objectives:
- To assess the relationship between the waking state and the consequences during the day according to sleep characteristics. These include:
-
Psychological results:
-
Quality of life.
-
Carer overload.
-
Physical results:
-
Sleepiness during the day.
-
Physical activity, intensity and length evaluation.
- To assess carers satisfaction with the intervention.
Method Randomized clinical trial, single blinding and performed in oncological patients carers in several practices. 2 samples of 40 carers. Intervention group will be taken through a seven session intervention with music; control group will undergo seven sessions of therapeutic education (as a reminder). Results will be evaluated using Pittsburgh Quality of Sleep Index, triaxial accelerometer, EuroQol-5D-5L, Caregiver Strain Index, Epworth Sleepiness Scale and Client Satisfaction Questionnaire.
Statistical analysis Basal values will be compared for both groups. Then the values before and after the intervention will be compared using Student's t distribution for normal continuous variables, and Wilcoxon's T test for paired data in continuous not normal variables. A multiple linear regression will be carried out.
The system developed for the PREDIMEDPLUS study will be used to process accelerometer data results. This semi-automated system manages data capture in a continuous stream in a central server of Malaga University. Processing and analysis of this data is also centralised, with an open source package, GGIR v. 1.5-1248
详细描述
BACKGROUND AND CURRENT STATUS
Sleep is a complex vital process in which humans spend a third of our lives. Insomnia is related to discontent with quality, length or continuity in that sleep, usually seen as problems to fall sleep, waking up frequently or a sleep that doesn't leave us rested. Progressive shortening on sleep length is a risk factor on developing obesity, diabetes, hypertension, cardiac related conditions and cerebrovascular accident, and can lead to premature death.
Insomnia affects work performance: in severe cases it may lead to a reduction in care or reflexes, increased risk of being involved in accidents, poor morale or social relationships, absence from work and quality of life and immunity reduction.
Regarding sleep decrease in informal carers it is observed that during the condition progress there are several changes in the patients. These changes are related to an increase on sleep alterations in carers, with a mayor prevalence (42 to 95%) in carers of patients with late stage cancer, compared to early stage patients carer (36 to 80%).
Another aspect that may be overlooked frequently is physical activity conducted by carers as a health preventive measure, due to the benefits that physical exercise reports on the health and well-being, including a reduction on risk factors for cardiovascular diseases, cancer, stress and depression reduction, carer overload, mental and cognitive health, and general well-being. Sleep quality improves when physical activity increases in carers.
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
- Single (Care Provider)
盲法说明
The masking is performed by assigning a mobile phone with headphones and an accelerometer to the carers of the control and intervention group and with the instruction not to mention what they heard to the evaluator; in this sense the participants do not know if they belong to the control or intervention group. However those who listen to music can conclude that it is an intervention group by themselves.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being informal carer of a domiciliary palliative care patient.
- •Having given informed consent to take part in the study.
排除标准
- •Informal carer with severe hypoacusia, making it difficult to listen to the music on the phone/use of headphones
- •Informal carer allergic to plastic and/or metal
- •Informal carer with a programmed trip in the 2 weeks the study takes place
- •Informal carer without mobile phone
结局指标
主要结局
Change from baseline sleep interruption level (number of awakenings and wakefulness after the onset of sleep) at 7 days by accelerometry
时间窗: Preintervention/Postintervention ( 0 and 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Change from baseline quality of self-perceived sleep at 7 days through The Pittsburgh Sleep Quality Index (PSQI).
时间窗: Pre-intervention/Post-intervention (0 and 7 days)
Validated into Spanish. It values the sleep quality perceived by the subject. 7 different scores are obtained from the result, granting information for several components of the sleep quality: subjective quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances (frequency of coughs, snores, heat, cold), sleeping pills intake, diurnal dysfunction (faculty to fall asleep through an activity because of tiredness). The sum of the scores in each component will be included into a Total Score (TS) from 0 to 21. According to Buysse and Cols, a TS of 5 will be the cutting point between a good and a bad sleep quality, less than 5 will show the presence of good sleep quality.
Change from baseline total sleep time and rest time (nighttime sleep and daytime rest / naps) at 7 days by accelerometry
时间窗: Preintervention/Postintervention (0 and 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Change from baseline levels of intensity of daily physical activity at 7 days by accelerometry.
时间窗: Preintervention/Postintervention ( 0 and 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Change from baseline sleep efficiency (percentage of time in bed sleeping) (at the beginning and at 7 days) at 7 days by accelerometry.
时间窗: Preintervention/Postintervention ( 0 and 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Change from baseline daytime sleepiness at 7 days through the Epworth Sleepiness Scale (ESS).
时间窗: Preintervention/Postintervention ( 0 and 7 days)
Self-administered scale to measure diurnal sleepiness with 8 questions, scoring from 0 to 3 for a maximum score of 24. This scale is validated in Spanish.
次要结局
- Change from baseline caregiver's effort index at 7 days through The Caregiver Strain Index Questionnaire (CSI)(Preintervention/Postintervention ( 0 and 7 days))
- Change from baseline quality of life of the caregiver at 7 days through the EuroQol-5D-5L.(Preintervention/Postintervention ( 0 and 7 days))
- Client Satisfaction Questionnaire (CSQ-8)(Postintervention (7 days))
- Socio-demographic carers data(Preintervention (0 days))
研究者
Francisco Javier Navarro Moya
BSc Nursing
Andaluz Health Service