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

May 1, 2017 updated by: Lonnie Zeltzer, University of California, Los Angeles
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

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

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles

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

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in pain threshold temperature
Time Frame: 12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session
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
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
5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Children's Hospital Los Angeles

Investigators

  • Principal Investigator: Lonnie K Zeltzer, MD, UCLA Pediatric Pain and Palliative Care Program

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

September 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-000420

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.

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