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Clinical Trials/NCT02105740
NCT02105740
Completed
Not Applicable

Hypnosis as a Complementary Practice in Pain Management, Anxiety and Depression in Oncological Patients

Gil Montenegro1 site in 1 country24 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Gil Montenegro
Enrollment
24
Locations
1
Primary Endpoint
Change of Pain Score in the Visual Analogue Scale
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Gil Montenegro
Responsible Party
Sponsor Investigator
Principal Investigator

Gil Montenegro

PhD student in medical science

University of Brasilia

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)

Study Sites (1)

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