Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients
- Conditions
- PainDepression Anxiety Disorder
- Interventions
- Behavioral: HypnosisBehavioral: Control
- Registration Number
- NCT02105740
- Lead Sponsor
- Gil Montenegro
- Brief Summary
The aim of this trial is to compare and evaluate the effects of hypnosis in cancer patients, to reduce the level of pain, anxiety and depression. The comparison was made through the scores on the Visual Analogue Scale (VAS) and the Hospital Anxiety and Depression Scale (HADS).
- Detailed Description
Volunteers cancer patients of both gender, aged between 40 and 70 years, susceptible to hypnosis, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS), will be randomized into two groups of 12 participants each. They might or might not present metastasis, whether or not performed cancer surgery, regardless of the location of the primary tumor, with or without concomitant surgical indication. It will be used the Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale (HADS) at 3 different times: at baseline, after 7 days and after 2 weeks of the first assessment. It will be done, in the hypnosis group, an hypnosis intervention. It consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression. Then, it will be evaluated the intensity of the pain as well as depression and anxiety in both groups. Finally, the results of both groups will be compared.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Patients of Both sexes
- Aged 40-70 years susceptible to hypnosis
- Who have cancer of the digestive tract and pain resulting from this cancer treatment These may or may not have metastasis, have done or not cancer surgery, regardless of the location of the primary tumor or its presence,with or without concomitant surgical indication.This will include patients who have pain scores ≥ 3 in the Visual Analogue Scale (VAS).
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Patient not suggestible to hypnosis
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Psychotropic drug users,
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Patients with severe psychiatric disorder, except depression and anxiety
,- Patient terminally ill cancer
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Patients with tumor or cancer metastasis in the central nervous system, _ Deaf and people with mental disabilities and cognitive.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypnosis Hypnosis Use of hypnosis in the reduction of the levels of pain, depression and anxiety. Control Control Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.
- Primary Outcome Measures
Name Time Method Change of Pain Score in the Visual Analogue Scale The study was done with each patient in the first three consecutive weeks after randomization Comparison was made through the scores in the Visual Analogue Scale (VAS) to measure the effect of hypnosis in pain among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale ranged from 0 to 10 points, without subscales. The better outcome occurs when the mean of the second or the third week decrease 3 points comparing with the first week, or when the mean of the third week decrease 3 points comparing with the second week.
- Secondary Outcome Measures
Name Time Method Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) The study was done with each patient in the first three consecutive weeks after randomization Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.
Trial Locations
- Locations (1)
UNB- Universidade de Brasilia
🇧🇷Brasilia, Distrito Federal, Brazil