- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02105740
Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients (HPMADOP)
February 12, 2017 updated by: Gil Montenegro
Hypnosis as a Complementary Practice in Pain Management, Anxiety and Depression in Oncological Patients
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Distrito Federal
-
Brasilia, Distrito Federal, Brazil, 70910900
- UNB- Universidade de Brasilia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypnosis
Use of hypnosis in the reduction of the levels of pain, depression and anxiety.
|
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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Pain Score in the Visual Analogue Scale
Time Frame: The study was done with each patient in the first three consecutive weeks after randomization
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS)
Time Frame: The study was done with each patient in the first three consecutive weeks after randomization
|
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.
|
The study was done with each patient in the first three consecutive weeks after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: GIL MONTENEGRO, DOUTORANDO
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
March 27, 2014
First Submitted That Met QC Criteria
April 2, 2014
First Posted (Estimate)
April 7, 2014
Study Record Updates
Last Update Posted (Actual)
March 30, 2017
Last Update Submitted That Met QC Criteria
February 12, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNB19739513900000030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on Hypnosis
-
Central Hospital, Nancy, FranceRecruitingCancer | Alzheimer Disease | Myocarditis | ParkinsonFrance
-
University of AarhusAarhus University HospitalCompleted
-
Rennes University HospitalCompleted
-
Hospital St. Joseph, Marseille, FranceRecruiting
-
Centre Hospitalier Intercommunal CreteilRecruiting
-
Assistance Publique - Hôpitaux de ParisCompletedUsing Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients (PACAH-UCA HV)Surgery | Hallux ValgusFrance
-
University of WashingtonNational Multiple Sclerosis SocietyCompleted
-
Lone Knudsen, MSc Psych, PhDTerminated
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Oregon Health and Science UniversityCompletedPrimary Insomnia | Psychophysiological InsomniaUnited States