An interventional study of Hypnosis and Control in Pain and Depression Anxiety Disorder, sponsored by Gil Montenegro. Completed at 1 site in Brazil. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-30.
Sponsored by Gil Montenegro · Not applicable, Interventional, and Supportive care
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).
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 24 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Gil Montenegro as lead sponsor.
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Exclusion Criteria:
Patients with severe psychiatric disorder, except depression and anxiety
,- Patient terminally ill cancer
Use of hypnosis in the reduction of the levels of pain, depression and anxiety.
Behavioral: Hypnosis
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.
Behavioral: Control
The hypnosis intervention 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 of the same.
The control and experimental groups respond in 3 different moments to Visual Analogue Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting will be made before the hypnosis. In the second meeting, within an interval of 7 days, the scales will be applied in all patients. Before applying the scales, the hypnosis group will be submitted to the session. The third meeting will occur two weeks later, where the scales will be only applied to compare the groups.
Change of Pain Score in the Visual Analogue Scale
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.
Time frame: The study was done with each patient in the first three consecutive weeks after randomization
Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS)
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.
Time frame: The study was done with each patient in the first three consecutive weeks after randomization
The recruitment process was conducted from March to December 2015. Thirty nine patients were invited. They had cancer of digestive tract from both genders, of 40-70 years, with pain scores ≥ 3 by (EVA). Were excluded: patients that used psychotropic drugs, with psychiatric disorders, terminally ill cancer, hearing impaired and mentally disabled.
| Milestone | Hypnosis | Control |
|---|---|---|
| Started | 12 | 12 |
| Second | 12 | 11 |
| Completed | 12 | 11 |
| Not completed | 0 | 1 |
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.
| units on a scale | Hypnosis | Control |
|---|---|---|
| First Week | 7.33 ± 2.38 | 5.58 ± 2.06 |
| Second Week | 3.67 ± 2.77 | 5.67 ± 3.36 |
| Third Week | 2.08 ± 2.61 | 4.75 ± 3.13 |
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.
| units on a scale | Hypnosis | Control |
|---|---|---|
| Anxiety First Week | 11.50 ± 4.60 | 11.33 ± 4.41 |
| Anxiety Second Week | 8.17 ± 3.76 | 11.50 ± 2.43 |
| Anxiety Third Week | 7.50 ± 3.39 | 8.89 ± 5.96 |
| Depression First Week | 9.75 ± 5.32 | 9.00 ± 3.76 |
| Depression Second Week | 7.00 ± 5.46 | 8.75 ± 4.75 |
| Depression Third Week | 6.25 ± 3.98 | 7.75 ± 5.10 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hypnosis | — | 0/12 (0%) | 0/12 (0%) |
| Control | — | 0/12 (0%) | 0/12 (0%) |
Participated in the study, patients with cancer of the digestive tract of the Clinic Palliative Care of Brasilia Base Hospital (HBDF) who present pain ≥ 3 on the Visual Analogue Scale
| Age, Continuous(years) | Hypnosis | Control | Total |
|---|---|---|---|
| Mean | 55.4 ± 6.6 | 55.8 ± 7.5 | 55.5 ± 6.5 |
| Sex: Female, Male(Participants) | Hypnosis | Control | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 6 | 5 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Hypnosis | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 12 | 24 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Hypnosis | Control | Total |
|---|---|---|---|
| Brazil | 12 | 12 | 24 |
| Pain(units on a scale) | Hypnosis | Control | Total |
|---|---|---|---|
| Mean | 7.3 ± 2.4 | 5.6 ± 2.0 | 6.4 ± 2.3 |
| Anxiety(units on a scale) | Hypnosis | Control | Total |
|---|---|---|---|
| Mean | 11.5 ± 4.6 | 11.3 ± 4.4 | 11.4 ± 4.4 |
| Depression(units on a scale) | Hypnosis | Control | Total |
|---|---|---|---|
| Mean | 9.8 ± 5.3 | 9.0 ± 3.8 | 9.4 ± 4.5 |
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