Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04915742 |
| Other study ID # |
2021/1366 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
May 31, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
Inonu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Summary
Purpose: Determining the Effect of Therapeutic Exercise and Thetahealing on Pain and Quality
of Life in Patients with Fibromyalgia Methods: Between February and April 2021, the study
started with 58 people who wanted to participate in the study from online platforms and the
study was completed with 34 people.
Findings: According to the power analysis, at least 34 people will participate in the study.
Participants will be divided into 2 groups as experimental and control, thetahealing and
exercise will be applied to the experimental group and only exercise sessions will be applied
to the control group. The study will be 2 sessions of online group exercises per week for 6
weeks and 1 session of tehetahealing will be applied to the experimental group for 6 weeks.
The evaluation will be carried out in the first week before the sessions start and in the
last week after the sessions are completed in the form of an online survey.Summary
Purpose: Determining the Effect of Therapeutic Exercise and Thetahealing on Pain and Quality
of Life in Patients with Fibromyalgia Methods: Between February and April 2021, the study
started with 58 people who wanted to participate in the study from online platforms and the
study was completed with 34 people.
Findings: According to the power analysis, at least 34 people will participate in the study.
Participants will be divided into 2 groups as experimental and control, thetahealing and
exercise will be applied to the experimental group and only exercise sessions will be applied
to the control group. The study will be 2 sessions of online group exercises per week for 6
weeks and 1 session of tehetahealing will be applied to the experimental group for 6 weeks.
The evaluation will be carried out in the first week before the sessions start and in the
last week after the sessions are completed in the form of an online survey.
Description:
Login Fibromyalgia (FM) is a non-articular, chronic rheumatic disease of unknown etiology,
characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and the
presence of multiple tender points (1). Diagnostic criteria were defined by the American
Rheumatism Association (ARA) in 1990 (2). In order to diagnose FM, there should be widespread
pain and sensitivity in 11 or more of 18 specific points (3). The etiopathogenesis of FM is
still unknown, but factors such as physical trauma, surgical intervention, infections, acute
or chronic emotional stress may play a triggering role (4). Various findings such as muscular
symptoms, cognitive complaints, depression, insomnia and fatigue accompanying chronic pain
have been described in patients with FM (5). Various psychopathological disorders have been
reported in FM. It is estimated that 1/3 of his patients have minor depression or anxiety.
However, it is not known whether anxiety and depression in FM cause chronic pain or
contribute to the severity of symptoms (3). Despite the various complaints of patients with
fibromyalgia, the fact that no significant impairment was found in physical examination and
laboratory tests suggests that the symptoms may be psychologically induced (6). Since the
etiology of fibromyalgia syndrome is unknown, pharmacological and non-pharmacological
treatment methods should be used in patient-specific combinations according to the prominent
symptoms and their severity (6).
Mental health as well as the physical health of FMS patients is frequently investigated. It
has been observed that depressions accompany FMS in the majority of patients (7 -11).
Likewise, FMS patients frequently get various psychiatric comorbidities such as panic
disorder and anxiety (12,13). In addition, studies consistently point to an increased rate of
designed suicide after the development of fibromyalgia in this patient group due to the
burden of the disease and the high prevalence of depression (14-16).
The role of psychological factors in fibromyalgia is a controversial issue. However, many
studies have shown that these patients experience deterioration in personality patterns,
increased stress levels, anxiety, depression, or other psychological symptoms (17,18).
Although psychological factors are not considered to be the primary cause of fibromyalgia,
there are findings that depression is a very important predictor of the development of FMS
(12,19). On the other hand, researchers have pointed out that fibromyalgia and depression
generally have two-way relationships by overlapping (18,20).
Theta gets its name from Teta brain waves. Generally, at night, while sleeping, during deep
meditation , and experiencing oneness in the universe, situations occur at the theta
wavelength. So the Theta state is a very deep state of relaxation . While in this wavelength
, we can easily connect with the brain so that our haunted beliefs here can be controlled.
This condition is associated with strong theta rhythmic activity patterns. Theta activities
occur in the electroencephalogram (EEG) between the client and the practitioner at a
wavelength of 4-7 Hz (21). ThetaHealing® (Vianna Stibal, Kalispell, MT) is a spiritual
healing method in which practitioner and client participate in joint meditations during
several subliminal sessions. Thetahealing is practiced by people who are internationally
trained in this field. It is claimed that these meditation periods are characterized by a
"theta state" in which the presence of theta waves in the electroencephalograph (EEG)
frequency spectrum of both the practitioner and the client is assumed (21) .
Located above the psychological and physiological bases for fibromyalgia origin information
in light of the Fibromyalgia Patients Group Exercise ii and Thetahealing Pain and e on
quality of life TKİ designed this study to determine n.
Method Our research is planned to be conducted entirely on an online platform in order not to
risk the participants due to the Covid-19 measures. The study will be carried out on a
voluntary basis.
Inclusion criteria for the study:
Being between the ages of 18-60 who have previously been diagnosed with fibromyalgia
Symptoms last longer than 3 months
The volunteer's acceptance of participation in the treatment that will continue 2 days a week
for 6 weeks ,
Exclusion criteria from the study:
Using psychotropic medication in the last month
Known central or peripheral nervous system disease, progressive neurological damage,
Any serious cardiovascular pathology.
Any musculoskeletal disease other than fibromyalgia,
Presence of uncontrolled hypertension,
Exclusion criteria:
Volunteer's request to leave
Failure to continue training sessions
S studies due to medical treatment received FMS Residence predicting the likelihood of any
changes mei
The data of our study will be analyzed with the SPSS (version 22.0) computer program.
Descriptive statistics techniques will be used to reveal the averages of all values of the
data obtained in the research (percentage and descriptive statistics, mean and standard
deviation values , t test, nonparametric tests if necessary ).
Since it will be a volunteer-based study, the volunteer can leave the study at any time.
Evaluation parameters to be used in research:
The socio-demographic information of the individuals who agreed to participate in the study
will be obtained.
It will be used 2 times, with all evaluation parameters before and after treatment.
Pg-36 will be used to evaluate the quality of life of the participants, the numerical pain
scale will be used to evaluate the pain levels, and the fibromyalgia impact questionnaire
will be used to evaluate the effect level of the disease.
Volunteers participating in our study will be randomly divided into 2 groups. In the
randomization of the groups, the assignment to the groups will be made with the randomizer
program using a computer. R astgel created in one of two exercise group (control group), the
other is exercise additional thetahealig (experimental group) group will have.
Thetahealing will be administered by the researcher who is an internationally trained
specialist physiotherapist (Appendix 1 Certificate).
The exercise group ha in FTAs 2, each session will be 30 minutes of evil sown in stretching ,
which made combining relaxation and strengthening exercises therapeutic exercise program for
6 weeks from the online platform will be implemented in the form of group exercise form is
planned.
The exercise and Thetahealing treatment group, on the other hand, is planned for 6 weeks , 1
session per week, 30 minutes per session, in addition to the exercise sessions, the first and
last sessions to be individual and personalized .
Applications will be carried out on the online platform.
Evaluation methods to be used in the study
Fibromyalgia Impact Questionnaire:
This scale; It measures 10 different characteristics: physical function, feeling unwell,
absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and
depression. Except for the sense of well-being, lower scores indicate improvement or less
affected by the disease. FEA is filled by the patient. The maximum possible score for each
subtitle is 10. Thus, the total maximum score is 100. While an average FM patient scores 50,
more severely affected FM patients usually score above 70 (1).
Short Form-36: SF-36 was developed to evaluate the quality of life. Its validity and
reliability study has been carried out in Turkey. SF-36 is used to compare general and
specific populations, to demonstrate the health benefits of different treatments, and to
monitor patients. The last 4 weeks are taken into account in the evaluation of SF-36, which
consists of 36 items ( 2-4 ).
Numerical Pain Scale s : D eg flood analogue scale on 0 (I have no pain) to 10 (I have a pain
in the degree intolerably) at the desired point is marked by giving a score between acquaint
feel the pain severity of patients (5 ).
The parameters to be used in the research are used routinely.
