Efficacy of Energy Therapy in the Management of Chronic Pain Medical Condition in Children and Adolescents.

NCT05394272 | Recruiting

• 1 other identifier: KCH22-058
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Paediatric and adolescent patients with chronic pain associated with their medical condition will be invited to participate in this study. Most patients for this study will be recruited from gastroenterology and hepatology clinics at KCH. Therefore the rationale for the study is primarily with consideration of each of these medical conditions all with the common symptom of chronic pain. Inflammatory bowel disease disorders(IBD), such as Crohn's Disease and Ulcerative Colitis, disorders of gut-brain interaction (DGBI) all experience chronic pain. however children with DGBI do not have an underlying specific lesion causing the pain. The chronic pain is the disease. In addition to this Chronic pancreatitis in children and adolescents can cause severe pain. All of these groups of patients suffer with chronic pain and this can result in failure to thrive and have a negative impact on quality of life. There is a need for further development of a non - pharmacological approach to support these patients with their symptoms of pain and in turn improve quality of life. This study is designed to evaluate the benefits of a complementary natural therapy for paediatric and adolescent patients registered at King's College Hospital, with a diagnosis of a disease or disorder with associated symptoms of chronic pain. The age group is 5-18 years old. The therapy to be evaluated is an energy therapy (Pranic Healing). This therapy is non -invasive, non- touch, non- pharmacological and natural. The study will assess the benefits these patients experience with their symptoms of pain after 8 weeks of weekly energy therapy sessions each session is 30 minutes and 3 visits each 4 weeks apart. Qualitative and Quantitative data will be collected and evaluated.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn Disease; Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• P-VAS validated questionnaire

  reduction in symptoms of chronic pain with Energy therapy

  20 weeks

Secondary Outcomes (1)

• stool samples/urine samples and blood tests

  Patient will have 8 weeks of treatment - 1 x week and 3 reviews 4 weeks apart

Study Arms (2)

Efficacy of Energy Therapy - Pranic Healing with chronic pain

EXPERIMENTAL

Energy therapy - Pranic Healing to be applied for 8 weeks weekly and 3 times 4 weeks apart for relief of chronic pain

Other: Energy Therapy - Pranic Healing

Efficacy of Energy Therapy - Pranic Healing - with linked medical condition

EXPERIMENTAL

Energy Therapy - Pranic Healing protocol for linked medical condition applied for 8 weeks weekly and 3 times 4 weeks apart , relevant BT/Urine sample /stool sample 4 weeks apart to evaluate changes.

Other: Energy Therapy - Pranic Healing

Interventions

Energy Therapy - Pranic Healing OTHER

Energy therapy - Non invasive non touch and non pharmacological - 100% natural complementary therapy

Efficacy of Energy Therapy - Pranic Healing - with linked medical condition; Efficacy of Energy Therapy - Pranic Healing with chronic pain

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Registered patients at King's College Hospital Male and Female 5-18 years old Symptoms of chronic pain associated with medical condition

You may not qualify if:

• Under 5 years of age and older than 18 years No symptoms of pain

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Pancreatitis; Pancreatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anju Bhatia, BDS

CONTACT

0203 2992495; anju.bhatia@nhs.net

Benjamin Hope, MBBS

CONTACT

benhope@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal, experimental qualitative and quantitative research project. Non-pharmacological, non- invasive, natural complementary therapy.

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 27, 2022
• Study Start: June 15, 2022
• Primary Completion: November 16, 2024
• Study Completion: June 16, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)