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

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Brief Title

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

Official Title

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

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

        1. 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)

        2. Post/email PIS/PIL age appropriate information booklet

        3. Informal information session / patient screening

        4. Parent /adolescent giving consent if wishing to participate

        5. Letter to GP informing of participation in study.

        6. Letter to school /employer with dates and times of appointments where appropriate and
           requested.

        7. 10 days prior to first session P-VAS completed daily Medication table for pain daily
           Journal

        8. 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.

        9. Daily completion of P-VAS/medication for pain and journal

       10. Weekly visits for 8 weeks - 30 minutes each visit

       11. 4 weeks stage PUCAI/PCDAI/FCP/BT/US/H&W to be collected.

       12. 8 week stage PUCAI/PCDAI/ H&W /FCP/BT/US to be collected.

       13. 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
    


Study Type

Interventional


Primary Outcome

P-VAS validated questionnaire

Secondary Outcome

 stool samples/urine samples and blood tests

Condition

Inflammatory Bowel Disease

Intervention

Energy Therapy - Pranic Healing

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

June 15, 2022

Completion Date

June 16, 2023

Primary Completion Date

June 16, 2023

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
      

Gender

All

Ages

5 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

, 0203 2992495, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT05394272

Organization ID

KCH22-058


Responsible Party

Sponsor

Study Sponsor

King's College Hospital NHS Trust


Study Sponsor

, , 


Verification Date

May 2022