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Trial record 51 of 697 for:    Sickle Cell Disease

A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02620488
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Lonnie Zeltzer, University of California, Los Angeles

Brief Summary:
This pilot study will assess the effects of a brief laboratory-based guided imagery procedure on responses to pain in patients with sickle cell disease (SCD) and healthy controls.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Guided Imagery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy Control
Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.
Behavioral: Guided Imagery
Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.

Experimental: Sickle Cell Disease
Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.
Behavioral: Guided Imagery
Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.




Primary Outcome Measures :
  1. Change in heart rate variability (HRV) before, during, and after hypnosis [ Time Frame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session ]
  2. Change in galvanic skin response (GSR) before, during, and after hypnosis [ Time Frame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session ]
  3. Change in overall respiration rate and rate of deep breathing (sighs) before, during, and after hypnosis [ Time Frame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session ]
  4. Change in peripheral blood flow (pulse oximetry) before, during, and after hypnosis [ Time Frame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session ]

Secondary Outcome Measures :
  1. Change in pain threshold temperature [ Time Frame: 12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session ]
  2. Change in pain tolerance temperature [ Time Frame: 9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session ]
  3. Change in heat pulse pain ratings [ Time Frame: 5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session ]


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy control or with a diagnosis of sickle cell disease
  2. Age 13 or older
  3. African-American
  4. Subject is able to provide informed signed consent
  5. Subject is able to follow instructions

Exclusion Criteria:

  1. Any known acute or chronic illness that in the judgment of the investigator, may compromise subject safety or data integrity
  2. Neurologic disorders affecting sensation
  3. Skin abnormality/abrasion over sites of stimulus
  4. Under 13 years of age
  5. Unable to follow instructions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620488


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Children's Hospital Los Angeles
Investigators
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Principal Investigator: Lonnie K Zeltzer, MD UCLA Pediatric Pain and Palliative Care Program

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Responsible Party: Lonnie Zeltzer, Distinguished Professor of Pediatrics, Anesthesiology, Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02620488     History of Changes
Other Study ID Numbers: 15-000420
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by Lonnie Zeltzer, University of California, Los Angeles:
Pain Perception
Autonomic Nervous System
Sickle Cell Disease
Hypnosis
Guided Imagery
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn