search
Back to results

Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress

Primary Purpose

Chronic Pain, Psychological Distress

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Integrative Yoga Therapy
Sponsored by
Aarogyam UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Experienced pain for > 3 months
  • Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
  • Willing to provide informed consent

Exclusion Criteria:

  • Severe medical or psychiatric conditions
  • Alcohol or substance abuse
  • Active suicidality
  • Terminal illness

Sites / Locations

  • Karyalaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrative Yoga Therapy

Wait-list Control

Arm Description

Integrative Yoga Therapy will be provided by yoga therapist once a week and participants will be encouraged to practice at home once or twice a day.

Participants in waiting list will serve as control group for the intervention period. After the ftherapy group has received treatment, the same program will be offered to participants in the wait-list control group.

Outcomes

Primary Outcome Measures

Pain Severity: Visual Analogue Scale
Visual Analogue Scale ranging between 0-10 where 0 is no pain at all and 10 is worst pain
Pain Disability
Change in pain disability using Pain Disability Index (PDI) with 7 item.Each item scores on 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability
Symptoms of depression and anxiety
Hospital Anxiety Depression Scale with 14 item. Each item on the questionnaire is scored from 0-3 where higher score represents increased anxiety and depression levels

Secondary Outcome Measures

Insomnia symptoms
Insomnia Severity Index has seven questions each scores between 0-4. Higher score defines severity of clinical insomnia
Mental well-being
The Short Warwick-Edinburgh Mental Wellbeing Scale; Minimum score: 7; maximum score: 35; higher score indicates greater level of wellbeing
Self Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale
Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale

Full Information

First Posted
March 18, 2020
Last Updated
March 19, 2020
Sponsor
Aarogyam UK
search

1. Study Identification

Unique Protocol Identification Number
NCT04315805
Brief Title
Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress
Official Title
Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Anticipated)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarogyam UK

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
This study will be a randomized wait list controlled trial studying the efficacy of an Integrative Yoga Therapy for patients with chronic pain and psychological distress. Individualised yoga program will consist of a 8-week guided self-help program. This study will primarily investigate whether an individually tailored yoga can be beneficial for patients suffering from chronic pain reducing pain, anxiety depression, while improving overall quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Psychological Distress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrative Yoga Therapy
Arm Type
Experimental
Arm Description
Integrative Yoga Therapy will be provided by yoga therapist once a week and participants will be encouraged to practice at home once or twice a day.
Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
Participants in waiting list will serve as control group for the intervention period. After the ftherapy group has received treatment, the same program will be offered to participants in the wait-list control group.
Intervention Type
Other
Intervention Name(s)
Integrative Yoga Therapy
Intervention Description
Yoga therapy will be based on personalised care consisting of Yoga relaxing posture, strengthening exercise, Yoga breathing, meditative psychotherapy, sound and imagery yoga practices, relaxation, yoga diet and life style management.
Primary Outcome Measure Information:
Title
Pain Severity: Visual Analogue Scale
Description
Visual Analogue Scale ranging between 0-10 where 0 is no pain at all and 10 is worst pain
Time Frame
From baseline to 8-week post intervention
Title
Pain Disability
Description
Change in pain disability using Pain Disability Index (PDI) with 7 item.Each item scores on 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability
Time Frame
From baseline to 8-week post intervention
Title
Symptoms of depression and anxiety
Description
Hospital Anxiety Depression Scale with 14 item. Each item on the questionnaire is scored from 0-3 where higher score represents increased anxiety and depression levels
Time Frame
From baseline to 8-week post intervention
Secondary Outcome Measure Information:
Title
Insomnia symptoms
Description
Insomnia Severity Index has seven questions each scores between 0-4. Higher score defines severity of clinical insomnia
Time Frame
From baseline to 8-week post intervention
Title
Mental well-being
Description
The Short Warwick-Edinburgh Mental Wellbeing Scale; Minimum score: 7; maximum score: 35; higher score indicates greater level of wellbeing
Time Frame
From baseline to 8-week post intervention
Title
Self Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale
Description
Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale
Time Frame
From baseline to 8-week post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Experienced pain for > 3 months Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress Willing to provide informed consent Exclusion Criteria: Severe medical or psychiatric conditions Alcohol or substance abuse Active suicidality Terminal illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Usha Solanki
Phone
+447448307225
Email
ukaarogyam@gmail.com
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
Facility Information:
Facility Name
Karyalaya
City
Leicester
State/Province
Leicestershire
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress

We'll reach out to this number within 24 hrs