Clinical trial NCT02105740: Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients
Official title: Hypnosis as a Complementary Practice in Pain Management, Anxiety and Depression in Oncological Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Depression Anxiety Disorder
Keywords: BEHAVIORAL
HYPNOSIS
ANXIETY
DEPRESSION
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: University of Brasilia
First posted: 2014-04-07
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change of Pain Score in the Visual Analogue Scale
timeFrame: The study was done with each patient in the first three consecutive weeks after randomization
Secondary outcomes:
measure: Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: The study was done with each patient in the first three consecutive weeks after randomization
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: UNB- Universidade de Brasilia
state: Distrito Federal
Study officials:
name: GIL MONTENEGRO, DOUTORANDO
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Montgomery GH, Bovbjerg DH, Schnur JB, David D, Goldfarb A, Weltz CR, Schechter C, Graff-Zivin J, Tatrow K, Price DD, Silverstein JH. A randomized clinical trial of a brief hypnosis intervention to control side effects in breast surgery patients. J Natl Cancer Inst. 2007 Sep 5;99(17):1304-12. doi: 10.1093/jnci/djm106. Epub 2007 Aug 28.
citation: Porter LS, Keefe FJ. Psychosocial issues in cancer pain. Curr Pain Headache Rep. 2011 Aug;15(4):263-70. doi: 10.1007/s11916-011-0190-6.
citation: Spiegel D, Bloom JR. Group therapy and hypnosis reduce metastatic breast carcinoma pain. Psychosom Med. 1983 Aug;45(4):333-9. doi: 10.1097/00006842-198308000-00007.
citation: Trijsburg RW, van Knippenberg FC, Rijpma SE. Effects of psychological treatment on cancer patients: a critical review. Psychosom Med. 1992 Jul-Aug;54(4):489-517. doi: 10.1097/00006842-199207000-00011.
citation: Landier W, Tse AM. Use of complementary and alternative medical interventions for the management of procedure-related pain, anxiety, and distress in pediatric oncology: an integrative review. J Pediatr Nurs. 2010 Dec;25(6):566-79. doi: 10.1016/j.pedn.2010.01.009. Epub 2010 Mar 12.