Sleep Clinical Trial
— IMECAOfficial title:
Intervention to Improve Sleep Quality in Caregivers of Palliative Care Patients in the Community: Clinical Trial
Verified date | March 2022 |
Source | Andaluz Health Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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: 1. Psychological results: 1. Quality of life. 2. Carer overload. 2. Physical results: 1. Sleepiness during the day. 2. 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
Status | Completed |
Enrollment | 80 |
Est. completion date | March 15, 2022 |
Est. primary completion date | February 12, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Being informal carer of a domiciliary palliative care patient. - Having given informed consent to take part in the study. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Inmaculada Valero Cantero | Málaga |
Lead Sponsor | Collaborator |
---|---|
Andaluz Health Service | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
Spain,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline quality of self-perceived sleep at 7 days through The Pittsburgh Sleep Quality Index (PSQI). | 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. | Pre-intervention/Post-intervention (0 and 7 days) | |
Primary | Change from baseline total sleep time and rest time (nighttime sleep and daytime rest / naps) at 7 days by accelerometry | 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. | Preintervention/Postintervention (0 and 7 days) | |
Primary | Change from baseline sleep interruption level (number of awakenings and wakefulness after the onset of sleep) at 7 days by accelerometry | 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. | Preintervention/Postintervention ( 0 and 7 days) | |
Primary | Change from baseline sleep ef?ciency (percentage of time in bed sleeping) (at the beginning and at 7 days) at 7 days by accelerometry. | 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. | Preintervention/Postintervention ( 0 and 7 days) | |
Primary | Change from baseline levels of intensity of daily physical activity at 7 days by accelerometry. | 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. | Preintervention/Postintervention ( 0 and 7 days) | |
Primary | Change from baseline daytime sleepiness at 7 days through the Epworth Sleepiness Scale (ESS). | 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. | Preintervention/Postintervention ( 0 and 7 days) | |
Secondary | Change from baseline caregiver's effort index at 7 days through The Caregiver Strain Index Questionnaire (CSI) | Aimed to be answered by the caregiver of dependent people, containing 13 items with True/False answer. Every positive answer scores for 1. If the total is higher or equal to 7 it indicates a high level of strain. Being validated in Spanish, this is the scale used to evaluate the emotional and physical situation of the caregiver regarding their need to take care of a person in palliative care. | Preintervention/Postintervention ( 0 and 7 days) | |
Secondary | Change from baseline quality of life of the caregiver at 7 days through the EuroQol-5D-5L. | questionnaire validated in Spanish will be used, which describes health condition in 5 dimensions (mobility, personal care, day-to-day activities, pain/discomfort and anxiety/depression). It also present a visual analogue scale (VAS) graded 0 to 100 with the inserts "worst conceivable health condition" and "best conceivable health condition" in 0 and 100 respectively. | Preintervention/Postintervention ( 0 and 7 days) | |
Secondary | Client Satisfaction Questionnaire (CSQ-8) | 8 questions answered through a Likert-type scale of 4 points and self-administered, with specific points to each item. The categories would be as follows: quality of the service, type of services, results and general satisfaction. It will include 3 open questions where the subjects answer what they liked most from the treatment, what they liked less, and what they would change. This tool has been proved to determine patient´s satisfaction with high reliability and coherence, being validated in the 8 items versions for Spanish speakers. | Postintervention (7 days) | |
Secondary | Socio-demographic carers data | : age, sex, civil status, education level, out-of-house job, time dedicated to care, help
received for care, time that they have been taking care of someone, time the patient has been under palliative care, relationship with the patient, and consumption of painkillers, anxiolytic and sleeping pills medication. |
Preintervention (0 days) |
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