Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients (HPMADOP)
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|ClinicalTrials.gov Identifier: NCT02105740|
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain Depression Anxiety Disorder||Behavioral: Hypnosis Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Hypnosis as a Complementary Practice in Pain Management, Anxiety and Depression in Oncological Patients|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Use of hypnosis in the reduction of the levels of pain, depression and anxiety.
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.
Active Comparator: 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.
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 [ Time Frame: 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.
- Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105740
|UNB- Universidade de Brasilia|
|Brasilia, Distrito Federal, Brazil, 70910900|
|Principal Investigator:||GIL MONTENEGRO, DOUTORANDO|