Clinical trial NCT05861518: 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
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Anxiety
Depression
Hypnosis
Keywords: fibromyalgia
hypnosis
depression
anxiety
analgesia
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-05-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: VAS
timeFrame: the changes in scale scores from baseline to sixth month
measure: depression scale
timeFrame: the changes in scale scores from baseline to sixth month
measure: anxiety
timeFrame: the changes in scale scores from baseline to sixth month
measure: Fibromyalgia
timeFrame: the changes in scale scores from baseline to sixth month
measure: Health Profile
timeFrame: the changes in scale scores from baseline to sixth month
Secondary outcomes:
measure: exercise
timeFrame: at six month later
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa yüksek ihtisas EAH
Study officials:
References: