Weighted Blankets after Brain Injury

  • Research type

    Research Study

  • Full title

    A feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury

  • IRAS ID

    285006

  • Contact name

    Laura Edwards

  • Contact email

    laura.edwards@nottingham.ac.uk

  • Sponsor organisation

    University Hospitals of Derby and Burton NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT04860973

  • Duration of Study in the UK

    1 years, 0 months, 31 days

  • Research summary

    Acquired brain injury (ABI), most commonly due to trauma (e.g. fall, road traffic accident), can have devastating consequences, affecting a person's physical and mental wellbeing. After a severe traumatic brain injury, patients commonly experience agitation, confusion, disorientation and memory loss ("post-traumatic amnesia"). This can be very distressing to patients and their family and friends.
    Sleep disturbance is commonly also seen after brain injury, and can further worsen anxiety, disorientation and fear.

    Treating these symptoms can be difficult - medication may over-sedate people, put them at risk of falling, or cause other side effects; reassurance and orientation is a main-stay of treatment, but patients often can't remember what they have been told. Patients often need close monitoring (1:1 supervision) by a member of staff, but can find this intrusive.

    “Deep touch pressure” (DTP) is a form of sensory input including being hugged, and can be mimicked by weighted blankets. This may benefit symptoms of anxiety and agitation in conditions including autism, dementia and dental phobias. Weighted blankets have been manufactured to be heavier than traditional bed linen (around 10% of the weight of the person using it) to provide DTP.

    DTP has been shown to calm children with development disorders (e.g. autism; attention deficit hyperactivity disorder) and reduce sleep latency. There is little evidence for the use of weighted blankets in adults in clinical settings, and none in ABI.

    We propose a feasibility study to study the use of weighted blankets to aid sleep and agitation after ABI in an NHS neurorehabilitation unit.
    30 patients will be randomised 1:1 to use a weighted blanket or normal hospital linen for 7 consecutive days/nights. Outcome will focus on feasibility of study delivery and acceptability to staff and patients, but will also look at clinical outcome measures including sleep, agitation and other interventions required.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    20/YH/0278

  • Date of REC Opinion

    16 Dec 2020

  • REC opinion

    Further Information Favourable Opinion