Depression Anxiety Disorder, Pain
Conditions
Keywords
BEHAVIORAL, HYPNOSIS, ANXIETY, DEPRESSION
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.
Interventions
BEHAVIORALHypnosis
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.
BEHAVIORALControl
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.
Sponsors
University of Brasilia
Gil Montenegro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* Patient not suggestible to hypnosis * Psychotropic drug users, * Patients with severe psychiatric disorder, except depression and anxiety ,- Patient terminally ill cancer * Patients with tumor or cancer metastasis in the central nervous system, \_ Deaf and people with mental disabilities and cognitive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Participant flow
Recruitment details
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.
Pre-assignment details
Were excluded: 3 patients weren't suggestible, 3 patients who had terminal cancer, 2 patients who reported low scores, and 7 patients for other reasons such as religious issues or not accepting the technique. One patient dropped out the treatment because he had limited mobility to return to the hospital.
Participants by arm
| Arm | Count |
|---|---|
| Hypnosis Use of hypnosis to reduct the levels of pain, depression and anxiety.
Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, 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. | 12 |
| 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.
Control : The control and experimental groups respond in 3 different moments to Visual Analog Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting was made before the hypnosis. In the second meeting, within an interval of 7 days, the scales were applied in all patients. Before applying the scales, the hypnosis group was submitted to the session. The third meeting occurred two weeks later, where the scales were only applied to compare the groups. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Control | Total | Hypnosis |
|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 7.5 | 55.5 years STANDARD_DEVIATION 6.5 | 55.4 years STANDARD_DEVIATION 6.6 |
| Anxiety | 11.3 units on a scale STANDARD_DEVIATION 4.4 | 11.4 units on a scale STANDARD_DEVIATION 4.4 | 11.5 units on a scale STANDARD_DEVIATION 4.6 |
| Depression | 9.0 units on a scale STANDARD_DEVIATION 3.8 | 9.4 units on a scale STANDARD_DEVIATION 4.5 | 9.8 units on a scale STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 24 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pain | 5.6 units on a scale STANDARD_DEVIATION 2 | 6.4 units on a scale STANDARD_DEVIATION 2.3 | 7.3 units on a scale STANDARD_DEVIATION 2.4 |
| Region of Enrollment Brazil | 12 participants | 24 participants | 12 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
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
Population: 24 cancer patients were allocated. They were aged between 40-70 years, of both genders, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS). One patient of the control group left the research.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypnosis | Change of Pain Score in the Visual Analogue Scale | First Week | 7.33 units on a scale | Standard Deviation 2.38 |
| Hypnosis | Change of Pain Score in the Visual Analogue Scale | Second Week | 3.67 units on a scale | Standard Deviation 2.77 |
| Hypnosis | Change of Pain Score in the Visual Analogue Scale | Third Week | 2.08 units on a scale | Standard Deviation 2.61 |
| Control | Change of Pain Score in the Visual Analogue Scale | First Week | 5.58 units on a scale | Standard Deviation 2.06 |
| Control | Change of Pain Score in the Visual Analogue Scale | Second Week | 5.67 units on a scale | Standard Deviation 3.36 |
| Control | Change of Pain Score in the Visual Analogue Scale | Third Week | 4.75 units on a scale | Standard Deviation 3.13 |
Comparison: The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) for both arms with a statistical power of 95%, significance level of 5%. Statistical analysis first compared the difference of means between hypnosis and control groups during three weeks.p-value: 0.03495% CI: [0.224, 5.11]ANOVA
Comparison: The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the second week in the hypnosis group.p-value: 0.00495% CI: [1.253, 6.08]ANOVA
Comparison: The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the third week in the hypnosis group.p-value: 095% CI: [2.918, 7.582]ANOVA
Secondary
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
Population: Were allocated 24 cancer patients, aged between 40-70 years, of both genders, with depression and anxiety score ≥ 9 in Hospital Anxiety and Depression Scale (HADS). One patient of the control group left the research.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypnosis | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Anxiety First Week | 11.50 units on a scale | Standard Deviation 4.6 |
| Hypnosis | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Anxiety Second Week | 8.17 units on a scale | Standard Deviation 3.76 |
| Hypnosis | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Anxiety Third Week | 7.50 units on a scale | Standard Deviation 3.39 |
| Hypnosis | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Depression First Week | 9.75 units on a scale | Standard Deviation 5.32 |
| Hypnosis | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Depression Second Week | 7.00 units on a scale | Standard Deviation 5.46 |
| Hypnosis | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Depression Third Week | 6.25 units on a scale | Standard Deviation 3.98 |
| Control | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Depression Second Week | 8.75 units on a scale | Standard Deviation 4.75 |
| Control | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Anxiety First Week | 11.33 units on a scale | Standard Deviation 4.41 |
| Control | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Depression First Week | 9.00 units on a scale | Standard Deviation 3.76 |
| Control | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Anxiety Second Week | 11.50 units on a scale | Standard Deviation 2.43 |
| Control | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Depression Third Week | 7.75 units on a scale | Standard Deviation 5.1 |
| Control | Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) | Anxiety Third Week | 8.89 units on a scale | Standard Deviation 5.96 |
Comparison: Statistical analysis evaluated if the difference of averages of anxiety at the hypnosis and control groups in the third week.
Comparison: Statistical analysis evaluated if the difference of averages of depression at the hypnosis and control groups in the third week.