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Trial record 3 of 9 for:    Completed | guided imagery | United States, California

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

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Lonnie Zeltzer, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02620488
First received: October 5, 2015
Last updated: May 1, 2017
Last verified: May 2017
  Purpose
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 Intervention
Sickle Cell Disease
Behavioral: Guided Imagery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Supportive Care
Official Title: A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by Lonnie Zeltzer, University of California, Los Angeles:

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

Enrollment: 28
Study Start Date: September 2015
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02620488

Locations
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
Principal Investigator: Lonnie K Zeltzer, MD UCLA Pediatric Pain and Palliative Care Program
  More Information

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
Study First Received: October 5, 2015
Last Updated: May 1, 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:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 25, 2017