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The Effect of Hypnosis in Fibromyalgia

Primary Purpose

Analgesia, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring fibromyalgia, hypnosis, depression, anxiety, analgesia

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female FMS patients 35 to 65 years receiving treatment for FMS for at least six months Exclusion Criteria: Patients with communication problems other rheumatological diseases major another medical diseases neurological and/or central nervous system diseases severe mental illnesses antipsychotic medication use

Sites / Locations

  • Bursa yüksek ihtisas EAH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1

Group 2

Arm Description

.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.

.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.

Outcomes

Primary Outcome Measures

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
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.
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.
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.
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

Secondary Outcome Measures

exercise
the patient continues to exercise at the recommended frequency (3 times a week)

Full Information

First Posted
April 12, 2023
Last Updated
May 16, 2023
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05861518
Brief Title
The Effect of Hypnosis in Fibromyalgia
Official Title
Effect of Hypnosis on Pain, Anxiety, and Quality of Life in Female Patients With Fibromyalgia: A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In the hypnosis group, the patients received hypnosis sessions of approximately 30 minutes each, in groups of three, once a week. During the first meeting with the hypnotist, information on hypnosis was given, and the method to be used was explained. Hypnosis was performed by a single practitioner. The first session included hypnosis induction, progressive muscular relaxation, and introduction to hypnosis. In the second session, in addition to the brief repetition of the first session, self-hypnosis training was given. The third session was applied the same way as the second session. While the hypnosis session focused on relaxation and pain, aerobic exercises were also suggested as a regular practice. In addition, self-hypnosis practices were suggested at least three days a week.The results of the scales administered to the participants at baseline were recorded, and these evaluations were repeated at the end of the sixth month. During the six-month period, all patients continued their current medical therapy. This is a randomized study showing the effects of standardized hypnosis and self-hypnosis as adjuvant on VAS, FIQ, depression, anxiety and NHL in patients with FMS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Anxiety, Depression, Hypnosis
Keywords
fibromyalgia, hypnosis, depression, anxiety, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
collecting data and continuing treatment
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
.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.
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
.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.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAS
Description
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
Time Frame
the changes in scale scores from baseline to sixth month
Title
depression scale
Description
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.
Time Frame
the changes in scale scores from baseline to sixth month
Title
anxiety
Description
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.
Time Frame
the changes in scale scores from baseline to sixth month
Title
Fibromyalgia
Description
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.
Time Frame
the changes in scale scores from baseline to sixth month
Title
Health Profile
Description
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
Time Frame
the changes in scale scores from baseline to sixth month
Secondary Outcome Measure Information:
Title
exercise
Description
the patient continues to exercise at the recommended frequency (3 times a week)
Time Frame
at six month later

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
35-65
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female FMS patients 35 to 65 years receiving treatment for FMS for at least six months Exclusion Criteria: Patients with communication problems other rheumatological diseases major another medical diseases neurological and/or central nervous system diseases severe mental illnesses antipsychotic medication use
Facility Information:
Facility Name
Bursa yüksek ihtisas EAH
City
Bursa
ZIP/Postal Code
16290
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol can be share.
IPD Sharing Time Frame
One year
IPD Sharing Access Criteria
For academic studies

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The Effect of Hypnosis in Fibromyalgia

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