Energy Therapy and Meditation Based Practice to Alleviate Sleep Difficulties in Adolescents and Young Persons With Liver Disease and Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Total sleep time
Study Overview
Brief Summary
Sleep difficulties have been identified as one of the most distressing symptoms for adolescents with Chronic Liver Disease (CLD), Autoimmune Liver Disease (AILD) and Liver Transplantation (LT), sleep difficulties have a direct negative impact on quality of life. The underlying pathophysiological mechanisms for this are complex. In addition Adolescents with chronic illness tend to have a higher rate of mental health problems than the general population. The complexity of sleep deprivation, fatigue, stress and anxiety, may well all be contributory factors to these patients having poor adherence to their medication. This in turn has a negative impact on the success of their tissue graft or indeed increases the likelihood for transplant surgery.
Due to the risks of medication toxicity and dependency, there is a need for further research to address the issues of insomnia, stress and anxiety with a non - pharmacological approach for these Adolescent chronically ill patients. Meditation Based Practices and Energy Therapies (Acupuncture) have gained robust scientific evidence over the last 20 years to demonstrate their efficacy for patients with insomnia, stress and anxiety.
This study aims to demonstrate the benefits of a non - touch Energy Therapy (ET) and a Meditation Based Practice (MBP) to relieve symptoms of insomnia, stress and anxiety in Adolescents with CLD, ALD and LT. The participants will be 16 - 24 years old. The intervention will have 3 groups, Standard of Care Group, MBP and ET. The intervention will be for 8 weeks with the ET and MBP group each receiving 1 hour of therapy each week for 8 weeks. The data will be collected with questionnaires and actigraph wrist devices.
Detailed Description
BACKGROUND AND RATIONALE The liver is a vital organ responsible for enabling our body to digest food and rid itself of toxic substances. There are more than 100 types of liver disease affecting both children and adults presenting with a wide variety of symptoms. Young people (YP) with chronic illness tend to have a higher rate of mental health problems compared to the general population, with psychosocial complex issues affecting adherence to medication and resulting poorer health outcomes. Adolescents that have liver transplants (LT) demonstrate an inferior success rate compared to children and adults across all solid organ transplant groups.
This seems to be partially attributed to the high rate of non - adherence to medication which is a common issue amongst this age group.
Adolescence is the peak time for the onset of mental health problems with approximately 50% of mental health illnesses appearing before the age of 14 years and 75% of mental health problems developing before the age of 24 years.
Rates of anxiety, depression and behaviour difficulties are further elevated in children and adolescents with physical health problems.
A diagnosis of Autoimmune liver disease (ALD) between the ages of 14 - 20 years has been found to be independently predictive of liver related death or the need for liver transplantation compared with other age groups. In view of organ shortages, avoiding transplantation in these patients is a priority and focus on non - adherence (NA) to medication in patients with ALD. The focus on minimising NA in ALD aims to prevent avoidable transplantation and after LT aims to reduce graft loss.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Randomised controlled trial
Eligibility Criteria
- Ages
- 16 Years to 24 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •16- 24 years old
- •Liver Disease/ Liver transplantation
- •Sleep Difficulties
Exclusion Criteria
- •Unable to follow instruction
- •Severe psychological illness
- •Current or recent participation in a research study
Outcomes
Primary Outcomes
Total sleep time
Time Frame: 22 weeks
Actigraph measures - Total sleep time (Mins)
wake after sleep onset
Time Frame: 22 weeks
Actigraph - Wake after sleep time (mins)
deep and light sleep
Time Frame: 22 weeks
Actigraph - deep and light sleep (mins)
Insomnia
Time Frame: 22 weeeks
Qualitative questionnaire - Pittsburgh Sleep Quality Index (PSQI) minimum score 0 maximum score 27 higher score indicates worse sleep quality
Secondary Outcomes
- Perception of illness(22 weeks)
- stress and anxiety(22 weeks)
- Depression(22 weeks)
Investigators
Anju Bhatia
Principal Investigator Dr Anju Bhatia
King's College Hospital NHS Trust
