Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients

NCT02105740 | Completed Results

• 1 other identifier: UNB19739513900000030
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain; Depression Anxiety Disorder

Keywords

BEHAVIORAL; HYPNOSIS; ANXIETY; DEPRESSION

Outcome Measures

Primary Outcomes (1)

• 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.

  The study was done with each patient in the first three consecutive weeks after randomization

Secondary Outcomes (1)

• 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 Arms (2)

Hypnosis

EXPERIMENTAL

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

Behavioral: Hypnosis

Control

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

Hypnosis 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.

Hypnosis

Control 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.

Control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gil Montenegro: lead
• University of Brasilia: collaborator

Study Sites (1)

UNB- Universidade de Brasilia

Brasília, Federal District, 70910900, Brazil

Location

Related Publications (7)

• 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.

  PMID: 17135649 BACKGROUND

• 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.

  PMID: 18154865 BACKGROUND

• 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.

  PMID: 17728216 BACKGROUND

• 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.

  PMID: 21400251 BACKGROUND

• 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.

  PMID: 6622622 BACKGROUND

• 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.

  PMID: 1502290 BACKGROUND

• 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.

  PMID: 21035021 BACKGROUND

MeSH Terms

Conditions

Pain; Behavior; Anxiety Disorders; Depression

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The hypnosis group were not blinded to the intervention. A short follow-up was given to each patient. The use of drugs was imbalanced among participants.

Results Point of Contact

• Title: Gil Montenegro
• Organization: Universidade de Brasília

prof.gilmontenegro@gmail.com

556181487323

Study Officials

• GIL MONTENEGRO, DOUTORANDO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student in medical science

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 7, 2014
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)