The Effect of Hypnosis in Fibromyalgia

NCT ID: NCT05861518

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-05-01

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.

Conditions

Analgesia; Anxiety; Depression; Hypnosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

.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.

Group Type: EXPERIMENTAL

Hypnosis

Intervention Type: 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 2

.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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hypnosis

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Seyda Efsun Ozgunay

Asocc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bursa yüksek ihtisas EAH

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2011-KAEK-25 2019/12-15

Identifier Type: -

Identifier Source: org_study_id