search
Back to results

Efficacy of Energy Therapy in the Management of Chronic Pain Medical Condition in Children and Adolescents. (ET&CP)

Primary Purpose

Inflammatory Bowel Disease, Ulcerative Colitis, Crohn Disease

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Energy Therapy - Pranic Healing
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • King's College Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Efficacy of Energy Therapy - Pranic Healing with chronic pain

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

Arm Description

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

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.

Outcomes

Primary Outcome Measures

P-VAS validated questionnaire
reduction in symptoms of chronic pain with Energy therapy

Secondary Outcome Measures

stool samples/urine samples and blood tests
stool samples - faecal calprotectin Faecal calprotectin

Full Information

First Posted
May 4, 2022
Last Updated
May 26, 2022
Sponsor
King's College Hospital NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT05394272
Brief Title
Efficacy of Energy Therapy in the Management of Chronic Pain Medical Condition in Children and Adolescents.
Acronym
ET&CP
Official Title
Efficacy of Energy Therapy in the Management of Chronic Pain and Associated Medical Condition in Children and Adolescents.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Anticipated)
Primary Completion Date
June 16, 2023 (Anticipated)
Study Completion Date
June 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Primary Objective: The primary objective of this study is to evaluate how effective a complementary therapy, Energy Therapy (Pranic Healing) is for children and adolescents that experience chronic pain. Secondary Objective: To evaluate efficacy of this energy therapy in reduction in clinical symptoms/pathology associated with the child's / adolescent's medical condition causing the chronic pain. Longitudinal, experimental qualitative and quantitative research project. Non-pharmacological, non- invasive, natural complementary therapy. The study is a controlled trial without randomisation experimental, longitudinal study designed to evaluate the efficacy of a non - pharmacological complementary therapies for children and adolescents with chronic.All participants are patients at King' College Hospital. Recruitment The initial recruitment for the study will be for patients from Gastroenterology and hepatology clinics at King's College Hospital. Patients with chronic pain with other medical conditions will be recruited as study progresses. All families will be contacted by the medical care team or via the patient database by post/email with the PIL/PIS and ET information booklet (age appropriate). Families will be contacted via email/ telephone, those interested in participation will be invited to an informal information session virtually or face to face. The PIS will be discussed, any concerns regarding the study will be clarified. Parents will be asked to give informed consent if they would like their child to participate. All participants will continue with their routine medical care and treatment at King's College Hospital. Baseline Characteristics To be collected prior to the intervention. Pain -Visual Analogue Scale P-VAS - to be completed for 10 days prior to first session and daily for the duration of the study Paediatric Ulcerative Colitis Activity Index (PUCAI) questionnaire- to be completed prior to the first session, subsequently every 4 weeks for the duration of the study for those patients with Ulcerative Colitis. Paediatric Crohn's Disease Activity Index (PCDAI) questionnaire -to be completed prior to the first session subsequently every 4 weeks for the duration of the study for those patients with Crohn's Disease. Faecal Calprotectin (FCP) - IBD PATIENTS will give a stool sample for a FCP test prior to their first session. Parents may bring the sample with them on the first appointment. FCP samples will then be collected every 4 weeks for the duration of the study for patients with IBD. Amylase (Blood test /Urine sample) BT/US Baseline level from last sample - patient records, collect sample at 4 weeks 8 weeks and 20 weeks (CP patients and pts where blood test routinely collected to evaluate clinical /physical symptoms). Height and Weight (H&W) will be recorded at the first visit and every 4 weeks for the duration of the study for all patients. Medication - a table recording medication dosage and frequency for abdominal pain will be requested to be completed for 10 days prior to the first session and every day throughout the study. Journal - A diary will be given to patients /parents for young children,10 days prior to the study and for completion logging any changes through the study with pain associated with Inflammatory Bowel Disease ( Ulcerative Colitis and Crohn's Disease) and Disorders of Gut- Brain Interaction and Chronic Pancreatitis and other medical conditions with manifestations of chronic pain 100 Recruitment process via referral from medical care team and patient database (registered paediatric and adolescent patients with chronic pain linked with medical condition at KCH) Post/email PIS/PIL age appropriate information booklet Informal information session / patient screening Parent /adolescent giving consent if wishing to participate Letter to GP informing of participation in study. Letter to school /employer with dates and times of appointments where appropriate and requested. 10 days prior to first session P-VAS completed daily Medication table for pain daily Journal First appointment for Energy Therapy- prior to session PUCAI or PCDAI for IBD participants. Collection of FCP/BT/ US sample, if baseline not available in patient records. H&W. Daily completion of P-VAS/medication for pain and journal Weekly visits for 8 weeks - 30 minutes each visit 4 weeks stage PUCAI/PCDAI/FCP/BT/US/H&W to be collected. 8 week stage PUCAI/PCDAI/ H&W /FCP/BT/US to be collected. Energy Therapy sessions to be every 4 weeks for 3 months. For the 3 visits PUCAI/PCDAI/H&W/FCP/BT/US For the final visit BT/US collection in addition. 22 weeks Inclusion Criteria: Registered Paediatric patient at King's College Hospital 5-18years of age Male and Female Diagnosis of medical condition with associated chronic pain Symptoms of Pain Exclusion Criteria Under 5 years old and older than 18 years old No symptoms of pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Ulcerative Colitis, Crohn Disease, Chronic Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal, experimental qualitative and quantitative research project. Non-pharmacological, non- invasive, natural complementary therapy.
Masking
Investigator
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Efficacy of Energy Therapy - Pranic Healing with chronic pain
Arm Type
Experimental
Arm Description
Energy therapy - Pranic Healing to be applied for 8 weeks weekly and 3 times 4 weeks apart for relief of chronic pain
Arm Title
Efficacy of Energy Therapy - Pranic Healing - with linked medical condition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Energy Therapy - Pranic Healing
Intervention Description
Energy therapy - Non invasive non touch and non pharmacological - 100% natural complementary therapy
Primary Outcome Measure Information:
Title
P-VAS validated questionnaire
Description
reduction in symptoms of chronic pain with Energy therapy
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
stool samples/urine samples and blood tests
Description
stool samples - faecal calprotectin Faecal calprotectin
Time Frame
Patient will have 8 weeks of treatment - 1 x week and 3 reviews 4 weeks apart

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Registered patients at King's College Hospital Male and Female 5-18 years old Symptoms of chronic pain associated with medical condition Exclusion Criteria: Under 5 years of age and older than 18 years No symptoms of pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anju Bhatia, BDS
Phone
0203 2992495
Email
anju.bhatia@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Hope, MBBS
Email
benhope@nhs.net
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anju Bhatia, BDS
Phone
0203 2992495
Email
anju.bhatia@nhs.net
First Name & Middle Initial & Last Name & Degree
Ben Hope, MBBS
Email
benhope@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs