Loading search results
IMECA
Intervention to Improve Sleep Quality in Caregivers of Palliative Care Patients in the Community: Clinical Trial
Sponsor study identifier
interventional
80
1 country
1
Study Start
September 1, 2020
Actual (reported)Primary Completion
February 12, 2022
Actual (reported)Study Completion
March 15, 2022
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 15, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 13, 2020
Actual (reported)July 29, 2020
Actual (reported)September 1, 2020
Actual (reported)February 12, 2022
Actual (reported)March 15, 2022
Actual (reported)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)
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)
Listening to pre-recorded and selected music preferred by the carer, half an hour for 7 days.
Basic therapeutic education repetition performed to all carer through earphones, half an hour for 7 days.
We are aiming to use music therapy, with pre-recorded favoured music, as a complementary treatment in oncological patients in palliative care, as well as on the carer. It will be done by using mobile telephones.
Basic therapeutic education repetition performed to all caregivers and oncological patients in palliative care, through mobile phones.
Inmaculada Valero Cantero
Málaga, 29014, Spain
Cappuccio FP, Miller MA. Sleep and Cardio-Metabolic Disease. Curr Cardiol Rep. 2017 Sep 19;19(11):110. doi: 10.1007/s11886-017-0916-0.
Im E, Kim GS. Relationship between sleep duration and Framingham cardiovascular risk score and prevalence of cardiovascular disease in Koreans. Medicine (Baltimore). 2017 Sep;96(37):e7744. doi: 10.1097/MD.0000000000007744.
Komada Y, Nomura T, Kusumi M, Nakashima K, Okajima I, Sasai T, Inoue Y. A two-year follow-up study on the symptoms of sleep disturbances/insomnia and their effects on daytime functioning. Sleep Med. 2012 Oct;13(9):1115-21. doi: 10.1016/j.sleep.2012.05.015. Epub 2012 Jul 25.
Inmaculada Valero Cantero, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
María Angeles Vázquez Sanchez, Doctor
University of Malaga
Yolanda Carrión Velasco, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
Milagrosa Espinar Toledo, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
80 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2020
First Posted
July 29, 2020
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)
Change from baseline sleep efficiency (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)
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)
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)
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Fu L, Jia L, Zhang W, Han P, Kang L, Ma Y, Yu H, Zhai T, Chen X, Guo Q. The association between sleep duration and physical performance in Chinese community-dwelling elderly. PLoS One. 2017 Mar 30;12(3):e0174832. doi: 10.1371/journal.pone.0174832. eCollection 2017.
Walsh JK. Clinical and socioeconomic correlates of insomnia. J Clin Psychiatry. 2004;65 Suppl 8:13-9.
Kotronoulas G, Wengstrom Y, Kearney N. Sleep patterns and sleep-impairing factors of persons providing informal care for people with cancer: a critical review of the literature. Cancer Nurs. 2013 Jan-Feb;36(1):E1-15. doi: 10.1097/NCC.0b013e3182456c38.
Harding R, Epiphaniou E, Hamilton D, Bridger S, Robinson V, George R, Beynon T, Higginson IJ. What are the perceived needs and challenges of informal caregivers in home cancer palliative care? Qualitative data to construct a feasible psycho-educational intervention. Support Care Cancer. 2012 Sep;20(9):1975-82. doi: 10.1007/s00520-011-1300-z. Epub 2011 Nov 10.
Dhruva A, Lee K, Paul SM, West C, Dunn L, Dodd M, Aouizerat BE, Cooper B, Swift P, Miaskowski C. Sleep-wake circadian activity rhythms and fatigue in family caregivers of oncology patients. Cancer Nurs. 2012 Jan-Feb;35(1):70-81. doi: 10.1097/NCC.0b013e3182194a25.
Lerdal A, Slatten K, Saghaug E, Grov EK, Normann AP, Lee KA, Bjorvatn B, Gay CL. Sleep among bereaved caregivers of patients admitted to hospice: a 1-year longitudinal pilot study. BMJ Open. 2016 Jan 4;6(1):e009345. doi: 10.1136/bmjopen-2015-009345.
Rittman M, Hinojosa MS, Findley K. Subjective sleep, burden, depression, and general health among caregivers of veterans poststroke. J Neurosci Nurs. 2009 Feb;41(1):39-52. doi: 10.1097/jnn.0b013e318193459a.
Gehrman P, Gooneratne NS, Brewster GS, Richards KC, Karlawish J. Impact of Alzheimer disease patients' sleep disturbances on their caregivers. Geriatr Nurs. 2018 Jan-Feb;39(1):60-65. doi: 10.1016/j.gerinurse.2017.06.003. Epub 2017 Jul 3.
Maltby KF, Sanderson CR, Lobb EA, Phillips JL. Sleep disturbances in caregivers of patients with advanced cancer: A systematic review. Palliat Support Care. 2017 Feb;15(1):125-140. doi: 10.1017/S1478951516001024. Epub 2017 Jan 18.
Reiner M, Niermann C, Jekauc D, Woll A. Long-term health benefits of physical activity--a systematic review of longitudinal studies. BMC Public Health. 2013 Sep 8;13:813. doi: 10.1186/1471-2458-13-813.
Lambert SD, Duncan LR, Kapellas S, Bruson AM, Myrand M, Santa Mina D, Culos-Reed N, Lambrou A. A Descriptive Systematic Review of Physical Activity Interventions for Caregivers: Effects on Caregivers' and Care Recipients' Psychosocial Outcomes, Physical Activity Levels, and Physical Health. Ann Behav Med. 2016 Dec;50(6):907-919. doi: 10.1007/s12160-016-9819-3.
Cuthbert CA, King-Shier K, Ruether D, Tapp DM, Culos-Reed SN. What is the State of the Science on Physical Activity Interventions for Family Caregivers? A Systematic Review and RE-AIM Evaluation. J Phys Act Health. 2017 Jul;14(7):578-595. doi: 10.1123/jpah.2016-0280. Epub 2017 Mar 14.
Hirano A, Suzuki Y, Kuzuya M, Onishi J, Ban N, Umegaki H. Influence of regular exercise on subjective sense of burden and physical symptoms in community-dwelling caregivers of dementia patients: a randomized controlled trial. Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):e158-63. doi: 10.1016/j.archger.2010.08.004. Epub 2010 Sep 17.
King AC, Baumann K, O'Sullivan P, Wilcox S, Castro C. Effects of moderate-intensity exercise on physiological, behavioral, and emotional responses to family caregiving: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2002 Jan;57(1):M26-36. doi: 10.1093/gerona/57.1.m26.
DeMartinis NA, Kamath J, Winokur A. New approaches for the treatment of sleep disorders. Adv Pharmacol. 2009;57:187-235. doi: 10.1016/S1054-3589(08)57005-0. Epub 2009 Nov 27.
Schroeck JL, Ford J, Conway EL, Kurtzhalts KE, Gee ME, Vollmer KA, Mergenhagen KA. Review of Safety and Efficacy of Sleep Medicines in Older Adults. Clin Ther. 2016 Nov;38(11):2340-2372. doi: 10.1016/j.clinthera.2016.09.010. Epub 2016 Oct 15.
Wilt TJ, MacDonald R, Brasure M, Olson CM, Carlyle M, Fuchs E, Khawaja IS, Diem S, Koffel E, Ouellette J, Butler M, Kane RL. Pharmacologic Treatment of Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):103-12. doi: 10.7326/M15-1781. Epub 2016 May 3.
Mercier J, Savard J, Bernard P. Exercise interventions to improve sleep in cancer patients: A systematic review and meta-analysis. Sleep Med Rev. 2017 Dec;36:43-56. doi: 10.1016/j.smrv.2016.11.001. Epub 2016 Nov 10.
van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9.
Davidson RJ, Irwin W. The functional neuroanatomy of emotion and affective style. Trends Cogn Sci. 1999 Jan;3(1):11-21. doi: 10.1016/s1364-6613(98)01265-0.
Peretz I, Gagnon L, Bouchard B. Music and emotion: perceptual determinants, immediacy, and isolation after brain damage. Cognition. 1998 Aug;68(2):111-41. doi: 10.1016/s0010-0277(98)00043-2.
Mizuno T, Sugishita M. Neural correlates underlying perception of tonality-related emotional contents. Neuroreport. 2007 Oct 29;18(16):1651-5. doi: 10.1097/WNR.0b013e3282f0b787.
Soria-Urios G, Duque P, Garcia-Moreno JM. [Music and brain: neuroscientific foundations and musical disorders]. Rev Neurol. 2011 Jan 1;52(1):45-55. Spanish.
Blood AJ, Zatorre RJ. Intensely pleasurable responses to music correlate with activity in brain regions implicated in reward and emotion. Proc Natl Acad Sci U S A. 2001 Sep 25;98(20):11818-23. doi: 10.1073/pnas.191355898.
Jespersen KV, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015 Aug 13;2015(8):CD010459. doi: 10.1002/14651858.CD010459.pub2.
Feng F, Zhang Y, Hou J, Cai J, Jiang Q, Li X, Zhao Q, Li BA. Can music improve sleep quality in adults with primary insomnia? A systematic review and network meta-analysis. Int J Nurs Stud. 2018 Jan;77:189-196. doi: 10.1016/j.ijnurstu.2017.10.011. Epub 2017 Oct 23.
Valero-Cantero I, Vazquez-Sanchez MA, Espinar-Toledo M, Corral-Perez J, Casals-Sanchez JL, Casals C. Effects of motivational music on sleep quality for caregivers of patients with advanced cancer: a randomized controlled trial. Support Care Cancer. 2026 Aug 3;34(8):824. doi: 10.1007/s00520-026-11038-6.
Valero-Cantero I, Carrion-Velasco Y, Casals C, Martinez-Valero FJ, Baron-Lopez FJ, Vazquez-Sanchez MA. Intervention to improve quality of sleep of palliative patient carers in the community: protocol for a multicentre randomised controlled trial. BMC Nurs. 2020 Nov 16;19(1):107. doi: 10.1186/s12912-020-00501-2.
Cristina Casals Sánchez, Doctor
University od Cádiz
Librado Valverde Velasco, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
Milagros Reyes Sánchez, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
Nuria Garcia-Agua Soler, Doctor
University of Malaga
Francisco Martínez Valero, chiropodist
National Health Service and Midlothian Foot Care, Dalkeith, Lothian, Scotland.
Francisco Javier Barón López, Doctor
University of Malaga
Jose Luís Casals Sánchez, Doctor
Hospital Universitario Virgen de la Victoria de Málaga
Ana Belén Arrabal Téllez, Nurse
Distrito Sanitario Axarquía-Este. Servicio Andaluz de Salud
Rosa Ana Serrano Benavente, doctor
Distrito Sanitario Axarquía-Este.Servicio Andaluz de Salud
Julia Wárnberg W, Doctor
University of Malaga
Study Start
September 1, 2020
Actual (reported)Primary Completion
February 12, 2022
Actual (reported)Study Completion
March 15, 2022
Actual (reported)Last Updated
March 17, 2022
Record last verified: 2022-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: