The Effect of Hypnosis in Fibromyalgia

NCT05861518 | Completed

• 1 other identifier: 2011-KAEK-25 2019/12-15
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia syndrome (FMS) is a chronic disease characterized by widespread pain of unknown origin, fatigue, sleep disturbances, and cognitive problems. In the treatment of FMS, it is known that pharmacological therapy reduces fatigue as well as pain, increases functionality, and has positive effects on general well-being. In functional magnetic resonance imaging (fMRI) studies, suggestion following hypnotic induction has been reported to be better at pain control in patients with FMS. Self-hypnosis is a technique performed by the patient himself. The patients were randomly divided into two groups using the closed envelope technique as Group 1: Hypnosis and Group 2: Control. Patients who had communication problems, had other rheumatological diseases, had major medical disease and received treatment, had neurological and/or central nervous system disease, had been using antipsychotic medication, had been treated with psychotherapy for the last three months, and did not want to participate in the study were excluded from the study. Demographic characteristics of the participants and fibromyalgia effect beck depression and anxiety scale, Nottingham health profile and Visual Analogue Scale (VAS) were applied and the results were recorded. At the end of the 6th month, all scales and patient controls were made and re-evaluated. In this study, we aimed to evaluate the effects of controlled, standardized adjuvant hypnosis on pain, depression, anxiety, aerobic exercise practices, quality of life, and disease impact score in patients with FMS who had been under treatment for at least six months.

Conditions

Analgesia; Anxiety; Depression; Hypnosis

Keywords

fibromyalgia; hypnosis; depression; anxiety; analgesia

Outcome Measures

Primary Outcomes (5)

• VAS

  Visual Analogue Scale (VAS) was used to determine the severity of pain and fatigue of the patients.(from 0 better, 10 the worse) on a 10 cm line in VAS

  the changes in scale scores from baseline to sixth month

• depression scale

  Beck depresion scale (BDI): BDI measures physical, emotional, cognitive, and motivational symptoms seen in depression. It is a self-assessment scale that includes 21 symptom categories. The highest score that can be obtained is 63, with a higher total score indicating a greater severity of depression.

  the changes in scale scores from baseline to sixth month

• anxiety

  Beck anxiety scale (BAI): BAI measures the frequency of anxiety symptoms experienced by an individual. It is a Likert-type self-assessment scale consisting of 21 items, each scored between 0 and 3. A high total score indicates a high level of anxiety experienced by the person.

  the changes in scale scores from baseline to sixth month

• Fibromyalgia

  Fibromyalgia Impact Questionnaire (FIQ): Except for the well-being property, low scores indicate recovery or less affliction. The maximum possible score on each subscale is 10, and the maximum total score that can be obtained is 100.

  the changes in scale scores from baseline to sixth month

• Health Profile

  Nottingham Health Profile (NHP): It contains a total of 38 questions in six areas: pain, physical abilities, energy level, sleep, social isolation, and emotional reaction. The response options for each item are "yes" and "no". Each subarea is scored between 0 and 100, with 0 indicating good health and 100 representing poor health

  the changes in scale scores from baseline to sixth month

Secondary Outcomes (1)

• exercise

  at six month later

Study Arms (2)

Group 1

EXPERIMENTAL

.Participants, who had been receiving treatment for FMS for at least six months at the physical therapy and rehabilitation outpatient clinic .Participants continued their current drug treatment. In the hypnosis group, the patients were given 3 hypnosis sessions once a week. in groups of 3, each standardized for approximately 30 minutes.

Behavioral: Hypnosis

Group 2

NO INTERVENTION

.Participants, who had been receiving treatment for FMS for at least six months at the physical therapy and rehabilitation outpatient clinic .Participants continued their current drug treatment.

Interventions

Hypnosis BEHAVIORAL

In the hypnosis group, patients were given hypnosis sessions of approximately 30 minutes each, in groups of three, once a week. In this way, session standardization was achieved. Arm catalepsy was suggested in all patients. The first session was used as hypnosis induction, progressive muscular relaxation and introduction to hypnosis. In the second session, in addition to the first session, self-hypnosis training was given. The second session was applied as the same 3rd session. In these patients, in addition to analgesia suggestions, the feeling of worthlessness was especially studied with the recommendation of a psychiatrist.

Group 1

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: 35-65
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• FMS patients
• to 65 years
• receiving treatment for FMS for at least six months

You may not qualify if:

• Patients with communication problems
• other rheumatological diseases
• major another medical diseases
• neurological and/or central nervous system diseases
• severe mental illnesses
• antipsychotic medication use

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa yüksek ihtisas EAH

Bursa, 16290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Anxiety Disorders; Depression; Fibromyalgia

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: collecting data and continuing treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asocc Prof

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 17, 2023
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year
• Access Criteria: For academic studies

Locations

TU (1)