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Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients (HPMADOP)

Primary Purpose

Pain, Depression Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hypnosis
Control
Sponsored by
Gil Montenegro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring BEHAVIORAL, HYPNOSIS, ANXIETY, DEPRESSION

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UNB- Universidade de Brasilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypnosis

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS)
Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.

Full Information

First Posted
March 27, 2014
Last Updated
February 12, 2017
Sponsor
Gil Montenegro
Collaborators
University of Brasilia
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1. Study Identification

Unique Protocol Identification Number
NCT02105740
Brief Title
Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients
Acronym
HPMADOP
Official Title
Hypnosis as a Complementary Practice in Pain Management, Anxiety and Depression in Oncological Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gil Montenegro
Collaborators
University of Brasilia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Depression Anxiety Disorder
Keywords
BEHAVIORAL, HYPNOSIS, ANXIETY, DEPRESSION

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
Use of hypnosis in the reduction of the levels of pain, depression and anxiety.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Pain Score in the Visual Analogue Scale
Description
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.
Time Frame
The study was done with each patient in the first three consecutive weeks after randomization
Secondary Outcome Measure Information:
Title
Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS)
Description
Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.
Time Frame
The study was done with each patient in the first three consecutive weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GIL MONTENEGRO, DOUTORANDO
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNB- Universidade de Brasilia
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70910900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17135649
Citation
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.
Results Reference
background
PubMed Identifier
18154865
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. doi: 10.1016/j.cden.2007.10.002.
Results Reference
background
PubMed Identifier
17728216
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.
Results Reference
background
PubMed Identifier
21400251
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.
Results Reference
background
PubMed Identifier
6622622
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.
Results Reference
background
PubMed Identifier
1502290
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.
Results Reference
background
PubMed Identifier
21035021
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.
Results Reference
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Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients

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