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Effects of Brief Guided Imagery for Chronic Pain in Patients Diagnosed With Fibromyalgia

Primary Purpose

Fibromyalgia, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
brief guided imagery
Sponsored by
Pablo Roitman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring Fibromyalgia, Guided Imagery, chronic pain

Eligibility Criteria

22 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient with Fibromyalgia that suffers from pain at least for 3 months

Exclusion Criteria:

  • lliterates

Sites / Locations

  • Ramat Eshkol Clalit health services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

brief guided imagery

control group

Arm Description

The study group of our research will go through six Brief Guided Imagery sessions. These sessions will be completed within two months and will last one hour each.

Outcomes

Primary Outcome Measures

Changes in Pain
pain will be measure by BPI questionnaire

Secondary Outcome Measures

Changes in Quality of Life
Quality of Life will be measure by SF36 questionnaire

Full Information

First Posted
July 19, 2016
Last Updated
February 1, 2021
Sponsor
Pablo Roitman
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1. Study Identification

Unique Protocol Identification Number
NCT02846194
Brief Title
Effects of Brief Guided Imagery for Chronic Pain in Patients Diagnosed With Fibromyalgia
Official Title
Effects of Brief Guided Imagery for Chronic Pain in Patients Diagnosed With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pablo Roitman

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effect that the Brief Guided Imagery (BGI) technique has on fibromyalgia patients suffering from chronic pain in regards to their sense of pain, wellbeing and quality of life. This study will explore whether daily training of one to two minutes exercises in Brief Guided Imagery can reduce chronic pain and improve the quality of life of patients by studying specifically patients suffering from fibromyalgia. Chronic pain is a common condition which affects person's physical and mental health. It occurs in between 10% to 40% of the population, depending on the exact research and chosen sample. In 2010 Manchikant et al. found an effect chronic pain has on human functioning and quality of life. A research from 2007 defined chronic pain as pain that lasts more than three months. Being long lasting by its nature, chronic pain has an ongoing effect on deteriorating the quality of life. In this regards, quality of life is scientifically determined by five modes: i. Physical wellbeing. ii. Mental wellbeing. iii. Social wellbeing. iv. Emotional wellbeing, and v. sense of development and self-realization. Chronic pain damages daily ongoing functions and is also related to sleep disturbances, stress and unemployment. A direct correlation was also found between chronic pain and psycho-social . One of the many results of chronic pain is the huge impact on the economy, such as absence from work due to sick leaves. The overall cost of chronic pain was found to be one percent of the total expense on health. The frequency and impact of chronic pain is such that some professionals define it as an epidemic. In many cases, chronic pain occurs with patients suffering from a wide spectrum of medical disorders. In 2007 Tunks et al. demonstrated that chronic pain often accompanies an illness that involves also a psychological aspect. Both Baird et al. in 2004 and Menzies et al. in 2012 found a significant positive effect daily guided imagery exercises have on chronic pain. The study proposes to research the specific technique of Brief Guided Imagery on chronic pain, and will focus on patients suffering from fibromyalgia. Fibromyalgia is a syndrome where a patient suffers from both chronic pain and a fatigue. The pain of fibromyalgia is characterized as abstract and non-localized, while the fatigue appears in a varying range of intensity. These symptoms are often accompanied by exhaustion, lack of energy, somatic disorders and psychologic symptoms such as depression. The ongoing pain, fatigue and depression cause fibromyalgia patients to further suffer from sleep disorders and diminishing ability to function. Menzies et al. studied in 2012 the effect of guided imagery exercises on the stress level, pain, fatigue and depression. The study also examined different physiologic blood markers (such as proteins, cytokines and C reactive. Menzies found a positive and significantly large improvement in the ability to control both stress and pain levels, and treat the depression of the participants. However, no significant changes were observed in the blood tests monitoring the levels of physiologic markers in the blood.
Detailed Description
Hypothesis Chronic pain imposes great suffering on patients as well as a heavy extra expenditure on the healthcare system . In addition, it many patients of chronic pain were found to also suffer from depression . Guided imagery was found to be an effective technique to reduce chronic pain deriving from muscle or skeletal pain and from fibromyalgia. Guided imagery treatment carries low therapeutic costs and is noninvasive. It also puts the main emphasis of the process on the patient's satisfaction .Furthermore, a quantitative study by Kaplan et al. in 2014 found that daily exercises of guided imagery improved the sense of wellbeing among university students. However, the improvement in the sense of wellbeing due to the practice of daily guided imagery was not tested empirically. Therefore, the investigators suggested research will look into the empirical effect of Brief Guided Imagery on chronic pain. The investigators will study the Colette technique for Brief Guided Imagery using short one to two minutes guided imagery exercises to try and determine the empiric effect brief exercises have on pain sensation and quality of life when performed by fibromyalgia patients with chronic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Pain
Keywords
Fibromyalgia, Guided Imagery, chronic pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
brief guided imagery
Arm Type
Experimental
Arm Description
The study group of our research will go through six Brief Guided Imagery sessions. These sessions will be completed within two months and will last one hour each.
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
brief guided imagery
Primary Outcome Measure Information:
Title
Changes in Pain
Description
pain will be measure by BPI questionnaire
Time Frame
Week 0 , Week 6
Secondary Outcome Measure Information:
Title
Changes in Quality of Life
Description
Quality of Life will be measure by SF36 questionnaire
Time Frame
week 0, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient with Fibromyalgia that suffers from pain at least for 3 months Exclusion Criteria: lliterates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anat Kaplun
Organizational Affiliation
Ministry of Health, Israel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pablo Roitman, MD
Organizational Affiliation
Clalit Heath Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ramat Eshkol Clalit health services
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15359221
Citation
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Results Reference
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PubMed Identifier
16095934
Citation
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Results Reference
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PubMed Identifier
6602967
Citation
Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.
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PubMed Identifier
16092637
Citation
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Results Reference
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PubMed Identifier
8080219
Citation
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7701092
Citation
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Lahmann C, Nickel M, Schuster T, Sauer N, Ronel J, Noll-Hussong M, Tritt K, Nowak D, Rohricht F, Loew T. Functional relaxation and guided imagery as complementary therapy in asthma: a randomized controlled clinical trial. Psychother Psychosom. 2009;78(4):233-9. doi: 10.1159/000214445. Epub 2009 Apr 28.
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Results Reference
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Links:
URL
http://drjerryepstein.org/content/psychophysiological-coherence-function-mental-imagery-practice
Description
Psychophysiological coherence as a function of mental imagery practice
URL
http://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/1471-2474-8-65
Description
Prediction of function in daily life following multidisciplinary rehabilitation for individuals with chronic musculoskeletal pain; a prospective study

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Effects of Brief Guided Imagery for Chronic Pain in Patients Diagnosed With Fibromyalgia

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