Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients

Pain Clinical Trial

— HPMADOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02105740
• Other study ID #: UNB19739513900000030
• Status: Recruiting
• Phase: N/A
• First received: March 27, 2014
• Last updated: July 14, 2015
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2015
• Source: University of Brasilia
• Contact: GIL MONTENEGRO, doutorado
• Phone: 055 61 81487323
• Email: prof.gilmontenegro[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This study's aim is to use hypnosis in cancer patients, in order to reduce the level of pain, as well as anxiety and depression, as compared to the control group. For this evaluation development the Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale ( HADS) will be used.

Description:

Volunteers cancer patients of both sexes, aged between 40 and 70 years of age, susceptible to hypnosis, which feature above three pain scores in EVA 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 or its presence, with or without concomitant surgical indication. Both groups receive hospital treatment protocol. 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. The experimental group will evaluate the effects of hypnosis on the intensity of pain as well as depression and anxiety. The control group only follow the hospital for treatment protocol, being evaluated by the scales as the progression of symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients of Both sexes

• Aged 40-70 years susceptible to hypnosis

• Who have cancer or pain Resulting from 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 above 3 in the Visual Analogue Scale (VAS).

Exclusion Criteria:

• Patient not susceptible 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 as Down syndrome, autism and others.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression Anxiety Disorder
• Depressive Disorder
• Pain

Intervention

Behavioral:
• 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.
• Control x Experimental Group
The control and experimental groups respond in 7 different distinct moments, with the Visual Analog Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation will be two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety

Locations

Country	Name	City	State
Brazil	UNB- Universidade de Brasilia	Brasilia	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Gil Montenegro	University of Brasilia

Country where clinical trial is conducted

Brazil, 

References & 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. Review. — View Citation

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. Review. — View 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 — View 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 C — View 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. Review. — View Citation

Spiegel D, Bloom JR. Group therapy and hypnosis reduce metastatic breast carcinoma pain. Psychosom Med. 1983 Aug;45(4):333-9. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of score of pain in the Visual Analogic Scale, using hypnosis.	Compare through the scores on the Visual Analogic Scale (VAS) the effect of hypnosis in reducing the pain among the 12 patients of the experimental group and the 12 patients of the control group. To measure the pain use the Visual Analógic Scale.	12 months	No
Secondary	Decrease of anxiety and depression with the use of hypnosis.	Comparison between the experimental group and the control group as to the effect of hypnosis in reducing anxiety and depression, using for this the Hospital Anxiety and Depression Scale (HADS): which has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS - D).	12 months	No