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

February 1, 2021 updated by: Pablo Roitman

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Ramat Eshkol Clalit health services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • lliterates

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
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.
Behavioral: brief guided imagery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Pain
Time Frame: Week 0 , Week 6
pain will be measure by BPI questionnaire
Week 0 , Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Quality of Life
Time Frame: week 0, Week 6
Quality of Life will be measure by SF36 questionnaire
week 0, Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pablo Roitman

Investigators

  • Study Director: Anat Kaplun, Ministry of Health, Israel
  • Principal Investigator: Pablo Roitman, MD, Clalit Heath Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 24, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0015-16COM2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on brief guided imagery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe