Back to resultsChronic Pain Self-Management With Integrative Yoga Therapy (IYT)
Primary Purpose
Chronic Pain, Chronic Nonmalignant Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Integrative Yoga Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Older than 18 years old.
- having a chronic pain of more than 3 months of duration, no matter the aetiology.
- Capable of understanding and giving written informed consent.
- Significant levels of distress and disability related to the pain at the beginning of treatment
Exclusion Criteria:
- Intelectual disability or cognitive impairment
- Planning to move out of area
- Serious mental illness
- Drugs or substance abuse in the last 6 months
- Post surgery or scheduled for surgery
- Cancer related pain
Sites / Locations
- Karyalaya
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Integrative Yoga Therapy
Arm Description
Self managed Yoga based practices were included in one to one sessions for 6-sessions.
Outcomes
Primary Outcome Measures
Pain Intensity
Analogical Visual Scale from 0 to 10 scores where 0 describes no pain and 10 worst pain.
Secondary Outcome Measures
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS). 14 item, 7 each of anxiety and depression. Each item score between 0-3.
Satisfaction with the treatment
Satisfaction with the treatment (CRES-4) 4 questions.
General Quality of Life
Nottingham Health Profile score between 0 to 100 where 0 is best and 100 is worst
Full Information
NCT ID
NCT04313426
First Posted
March 17, 2020
Last Updated
March 17, 2020
Sponsor
Aarogyam UK
Collaborators
Hindu Swayamsevak Sangh (UK), Leicester Ageing Together
1. Study Identification
Unique Protocol Identification Number
NCT04313426
Brief Title
Chronic Pain Self-Management With Integrative Yoga Therapy (IYT)
Official Title
Evaluating Community-Based Pain Self-Care Using Integrative Yoga Therapy (IYT): Quasi Experimental Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
November 6, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarogyam UK
Collaborators
Hindu Swayamsevak Sangh (UK), Leicester Ageing Together
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to evaluate efficacy of chronic pain self-management program in community settings to adopt Integrative Yoga Therapy (IYT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Chronic Nonmalignant Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Integrative Yoga Therapy
Arm Type
Experimental
Arm Description
Self managed Yoga based practices were included in one to one sessions for 6-sessions.
Intervention Type
Other
Intervention Name(s)
Integrative Yoga Therapy
Intervention Description
Integrative Yoga Therapy included personalised yoga therapy sessions including their standard care, yoga movements, relaxation, meditation, breathing practices and yoga counselling sessions.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Analogical Visual Scale from 0 to 10 scores where 0 describes no pain and 10 worst pain.
Time Frame
From baseline to 6-week post intervention
Secondary Outcome Measure Information:
Title
Anxiety and Depression
Description
Hospital Anxiety and Depression Scale (HADS). 14 item, 7 each of anxiety and depression. Each item score between 0-3.
Time Frame
From baseline to 6-week post intervention
Title
Satisfaction with the treatment
Description
Satisfaction with the treatment (CRES-4) 4 questions.
Time Frame
From Baseline to 6-week post intervention
Title
General Quality of Life
Description
Nottingham Health Profile score between 0 to 100 where 0 is best and 100 is worst
Time Frame
From baseline to 6-week post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older than 18 years old.
having a chronic pain of more than 3 months of duration, no matter the aetiology.
Capable of understanding and giving written informed consent.
Significant levels of distress and disability related to the pain at the beginning of treatment
Exclusion Criteria:
Intelectual disability or cognitive impairment
Planning to move out of area
Serious mental illness
Drugs or substance abuse in the last 6 months
Post surgery or scheduled for surgery
Cancer related pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Aarogyam UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaydeep Joshi, BAMS
Organizational Affiliation
Aarogyam UK
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Usha Solanki
Organizational Affiliation
Hindu Swayamsevak Sangh
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bharti Mistry
Organizational Affiliation
Leicester Ageing Together
Official's Role
Study Chair
Facility Information:
Facility Name
Karyalaya
City
Leicester
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Chronic Pain Self-Management With Integrative Yoga Therapy (IYT)
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