Clinical trial NCT02846194: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Keywords: Fibromyalgia
Guided Imagery
chronic pain
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 37
Sex: ALL
Minimum age (years): 22
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* lliterates

Primary outcomes:
measure: Changes in Pain
timeFrame: Week 0 , Week 6
Secondary outcomes:
measure: Changes in Quality of Life
timeFrame: week 0, Week 6
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Ramat Eshkol Clalit health services
Study officials:
affiliation: Ministry of Health, Israel
name: Anat Kaplun
role: STUDY_DIRECTOR
affiliation: Clalit Heath Services
name: Pablo Roitman, MD
role: PRINCIPAL_INVESTIGATOR
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