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Trial record 3 of 67 for:    Completed Studies | guided imagery

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

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ClinicalTrials.gov Identifier: NCT02846194
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Clalit Health Services

July 19, 2016
July 27, 2016
January 25, 2018
July 2016
December 2017   (Final data collection date for primary outcome measure)
Changes in Pain [ Time Frame: Week 0 , Week 6 ]
pain will be measure by BPI questionnaire
Same as current
Complete list of historical versions of study NCT02846194 on ClinicalTrials.gov Archive Site
Changes in Quality of Life [ Time Frame: week 0, Week 6 ]
Quality of Life will be measure by SF36 questionnaire
Same as current
Not Provided
Not Provided
 
Effects of Brief Guided Imagery for Chronic Pain in Patients Diagnosed With Fibromyalgia
Effects of Brief Guided Imagery for Chronic Pain in Patients Diagnosed With Fibromyalgia

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
  • Fibromyalgia
  • Chronic Pain
Behavioral: brief guided imagery
  • Experimental: brief guided imagery
    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.
    Intervention: Behavioral: brief guided imagery
  • No Intervention: control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
80
January 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • lliterates
Sexes Eligible for Study: All
22 Years to 72 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT02846194
0015-16COM2
No
Not Provided
Plan to Share IPD: Undecided
Clalit Health Services
Clalit Health Services
Not Provided
Study Director: Anat Kaplun Ministry of Health, Israel
Principal Investigator: Pablo Roitman, MD Clalit Heath Services
Clalit Health Services
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP