Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients

NCT ID: NCT02105740

Last Updated: 2017-03-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Pain Depression Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hypnosis

Use of hypnosis in the reduction of the levels of pain, depression and anxiety.

Group Type EXPERIMENTAL

Hypnosis

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Interventions

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Hypnosis

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.

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Brasilia

OTHER

Sponsor Role collaborator

Gil Montenegro

OTHER

Sponsor Role lead

Responsible Party

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Gil Montenegro

PhD student in medical science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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GIL MONTENEGRO, DOUTORANDO

Role: PRINCIPAL_INVESTIGATOR

Locations

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UNB- Universidade de Brasilia

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

References

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Bardia A, Barton DL, Prokop LJ, Bauer BA, Moynihan TJ. Efficacy of complementary and alternative medicine therapies in relieving cancer pain: a systematic review. J Clin Oncol. 2006 Dec 1;24(34):5457-64. doi: 10.1200/JCO.2006.08.3725.

Reference Type BACKGROUND
PMID: 17135649 (View on PubMed)

Lalla RV, Sonis ST, Peterson DE. Management of oral mucositis in patients who have cancer. Dent Clin North Am. 2008 Jan;52(1):61-77, viii. doi: 10.1016/j.cden.2007.10.002.

Reference Type BACKGROUND
PMID: 18154865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17728216 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21400251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6622622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1502290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21035021 (View on PubMed)

Other Identifiers

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UNB19739513900000030

Identifier Type: -

Identifier Source: org_study_id

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