Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05003050 |
| Other study ID # |
KingCHLDH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2021 |
| Est. completion date |
March 10, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
King's College Hospital NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
Hames aimed to identify from a large cohort of YP who had already received a LT having had
ALD and CLD their prevalence rates of anxiety and depression and factors associated with
this.
These patient's demonstrated, psychological stresses worry (30.2 %) and low self - esteem
(27.5%) among physical complaints almost 50% cited fatigue. Nearly 33% of participants also
cited sleep difficulties.
Sleep difficulties have been identified as one of the most distressing symptoms for
adolescents with LT and they are negatively correlated with health related quality of life in
both children and adolescents. It has been, suggested psychological interventions for sleep
problems are highly effective and should be evaluated for this population as a priority.
Patients with CLD or patients who have had LT both cohorts exhibit sleep difficulties.
Due to the potential for medication toxicity in these disabled patients further studies are
needed to address the potential role of non - drug therapies (eg. CBT, mindfulness, yoga). It
is not, recommended for these young people with chronic illness to then take medication for
insomnia due to toxicity risks.
Insomnia and fatigue will affect school, home life, medical health and medication adherence.
There therefore is a true clinical need for complementary therapies to be considered.
Meditation and Energy associated therapies have shown efficacy with patients that have
chronic illness/ pain /insomnia. These complimentary therapies are often Eastern in origin
however during the last 30 years these therapies have been practiced and researched widely in
the UK, demonstrating efficacy in multiple dimensions.
Meditation and Energy Therapy Meditation can be defined as a family of complex emotional and
attentional regulatory training regimes - developed for various ends including the
cultivation of wellbeing and emotional balance.
There has been an explosion of interest in mindfulness based programs such as Mindfulness
based stress reduction program (MBSR) and mindfulness based cognitive therapy (MBCT) in the
last 2 decades.
MBSR has accrued a robust evidence base in improving mental health outcomes in those with
chronic physical health problems. MBCT is an adaptation of the MBSR program, developed to
teach those at risk of depressive relapse, skills to stay well and has been shown to be
effective.
The durability of the MBSR program is notable, benefits have been obtained with no evidence
of adverse events with these findings, suggesting clinicians should consider recommending
MBSR to transplant recipients that are affected by these symptoms particularly anxiety and
poor sleep.
Those with chronic illness such as ALD and LT are more susceptible to stress and anxiety and
a higher prevalence of S&A and depression in YP and is demonstrated by Hames at King's
College Hospital London. .
Although in its infancy in the 'Western World, Energy therapies are demonstrating they can
help as a valuable adjunct to traditional medical practices to enhance the recovery process
of patients.
Of the family of energy therapies Acupuncture is the first wave, acupuncture is widely
practiced globally and within the UK and the NHS, for 30 years.
Similar to acupuncture Pranic Healing is an Energy Therapy with fundamental, principles and
beliefs akin to those in acupuncture.
This Energy Therapy is based on the principle that energy flows freely throughout the body
via channels and again similarly to acupuncture, energy is removed from specific points
around the affected area that has stagnated energy and often causing pain. Removal of this
energy enables free flow to again resume and recovery to occur. Pranic Healing similar to
acupuncture follows exact protocols for each condition. It is a non - touch systematic
therapy. For each physiological and psychological condition there is an exact protocol that
must followed precisely for the treatment to be effective.
Acupuncture has proved itself to be effective for many chronic illnesses as an adjunct to
traditional medical practice and has been recognised as an alternative medical therapy for
insomnia.
As there is a real need to provide complementary non pharmacological therapy for YP with
liver disease, insomnia and its associated difficulties. T'his study is justified in
evaluating 2 complementary therapies that are non-pharmacological, akin in approach to
recognised and utilised complementary therapies already in practice in the NHS (MBSR and
Acupuncture ) The aspiration being that YP with ALD / LT suffering with insomnia, stress and
anxiety will have improvements in their symptoms in turn improving their quality of life and
adherence to medication.
OBJECTIVES Primary Objective
- To give these patients an opportunity to experience a therapy that is non -
pharmacological
- To experience inner peace and relaxation during these sessions
- To improve sleep quality for these patients
- To reduce stress and anxiety within the body
- To reduce fatigue
Secondary Objectives
- To improve their overall wellbeing
- To encourage them to feel more positive within their lives
- To improve their adherence to medication
STUDY DESIGN DESIGN AND METHODOLOGY This study is an experimental, longitudinal study
designed to evaluate the efficacy of 2 non pharmacological complementary therapies for
patients with ALD, CLD, LT, sleep difficulties, stress and anxiety.
PARTICIPANT SAMPLE All participants are registered patients at King's College Hospital
Paediatric liver, GI and Nutrition Centre.
Sample size 10 patients for each group - 3 groups Both genders Ages 16- 24 years All
participants will have received a LT or have some form of CLD and will be selected from the
KCH patient data base, all interviews and treatment sessions will be conducted at KCH.
Patients will receive an information letter and patient participation sheet via post.
Interested participants will have a one - hour information session.
Patients that are eligible will then have baseline characteristics assessed and be allocated
to one of the 3 participant groups.
Meditation Based Practice Energy Therapy -Pranic Healing Standard of Care
All participants will continue with their routine care, medication and treatment at KCH. The,
three groups will run parallel and independent of each other.
This is a randomised control trial. BASELINE CHARACTERISTICS -will be, taken prior to the
intervention. PARTICIPANT INFORMATION - participation information sheet, an information
booklet explaining what will happen during the intervention, a sleep hygiene information
sheet, Actigraphy watches (Fitbit). Participants will be requested to wear this for 2 weeks
prior to the intervention, throughout the intervention and for 2 weeks afterwards and again
at 3 months for 2 weeks.
DATA COLLECTION Subjective data - Questionnaires, sleep diary and calendar for both groups.
Questionnaires - will be completed prior to the intervention, at the end of 8 weeks and again
at 3 months The IMPARTS (Integrated mental and physical healthcare Research: Training
Services) System contains a core set of measures, these will form part of the questionnaires
in this study.
1. PHQ9
2. GAD7
3. BIPQ
4. PSQI Assesses 7 domains of sleep - quality, latency, duration, efficiency, disturbances,
benefit of sleep medication and daytime dysfunction Sleep diary - A sleep diary is
attached, participants to complete each morning for 8 weeks Objective data Actigraphy -
To record sleep, and record movements that can be used to estimate sleep parameters.
Measurements will be TST - total sleep time WASO- wake after sleep onset. Deep sleep and
light Sleep.
MEDICATION - Documentation of patient's medication dose and frequency prior to intervention
will be recorded and continue in the normal way.
RANDOMISATION - Participants will be, randomly allocated to one of the three groups.
30 blank envelopes, within each will have one of the three groups stated
- Meditation Based practice - Pranic Healing - Standard of Care The envelopes will be
sealed and blank. Placed into a closed box. Recruitment lead will pick out an envelope
for the participants and they will be, allocated to the group named on the inside of the
envelope. Once participants have been, allocated to one of the three groups, they will
then, be given the relevant information and support.
SESSION DESIGN MEDITATION BASED PRACTICE Participants will meet the meditation teacher prior
to the intervention and have the opportunity to ask any questions. They will be given
booklets explaining the techniques and benefits of the techniques which the will be carried
out in each session.
Home practice in between sessions is encouraged, with CDs of the meditations. Each session
will be one hour each week, the sessions will be online/virtual for 8 consecutive weeks.
Participants will be, given sleep diaries to complete each morning and actigraph watches The
sessions will always contain the same elements. There will be 3- 5 participants in each group
PRANIC HEALING Participants will have the opportunity to meet the therapist prior to the
intervention and have the opportunity to ask any questions.
Participants will be, given a booklet explaining energy therapy and its benefits, a calendar
with the dates and times of the sessions, sleep diaries to complete each morning, actigraph
watches.
The session will be one hour each week for 8 weeks consecutively The session will be 1:1
Participant will sit in a comfortable chair The therapist will carry out exact protocols for
sleep, stress and anxiety. The treatment session is painless, non - invasive and non- touch.
STANDARD OF CARE Participants will have their data recorded in the same way as above. Routine
medical care will continue with no intervention. All will be offered both therapies after 8
weeks of study.
