Energy Therapy and Meditation Based Practice for Sleep Difficulties

NCT05003050 | Completed

• 1 other identifier: KingCHLDH
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (4)

• Total sleep time

  Actigraph measures - Total sleep time (Mins)

  22 weeks

• wake after sleep onset

  Actigraph - Wake after sleep time (mins)

  22 weeks

• deep and light sleep

  Actigraph - deep and light sleep (mins)

  22 weeks

• Insomnia

  Qualitative questionnaire - Pittsburgh Sleep Quality Index (PSQI) minimum score 0 maximum score 27 higher score indicates worse sleep quality

  22 weeeks

Secondary Outcomes (3)

• stress and anxiety

  22 weeks

• Perception of illness

  22 weeks

• Depression

  22 weeks

Study Arms (3)

Meditation Based Group

EXPERIMENTAL

8 sessions weekly for 8 weeks Each session for 1hour Sessions on line (virtual) Self-care tools and techniques, mindfulness and meditation

Other: Meditation

Energy Therapy (Pranic Healing)

EXPERIMENTAL

8 Sessions Weekly sessions for 8 weeks Each session 1 hour Pranic Healing (Energy Therapy)

Other: Pranic Healing

Stanrd of Care Group

NO INTERVENTION

Routine medical care and appointments

Interventions

Meditation OTHER

Holistic natural therapy

Meditation Based Group

Pranic Healing OTHER

Energy therapy

Energy Therapy (Pranic Healing)

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 16- 24 years old
• Liver Disease/ Liver transplantation
• Sleep Difficulties

You may not qualify if:

• Unable to follow instruction
• Severe psychological illness
• Current or recent participation in a research study

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Meditation

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anil Dhawan, MD FRCPCH

  Director Research and Innovation King's College Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomised controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr Anju Bhatia

Model Details: 3 groups each group 10 participants 10 Standard of Care Group 10 Meditation Based Practice 10 Energy Therapy (Pranic Healing)

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 12, 2021
• Study Start: August 16, 2021
• Primary Completion: January 15, 2022
• Study Completion: March 10, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)