search
Back to results

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

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Imagery
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sickle Cell Disease focused on measuring Pain Perception, Autonomic Nervous System, Sickle Cell Disease, Hypnosis, Guided Imagery

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Control

Sickle Cell Disease

Arm Description

Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.

Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.

Outcomes

Primary Outcome Measures

Change in heart rate variability (HRV) before, during, and after hypnosis
Change in galvanic skin response (GSR) before, during, and after hypnosis
Change in overall respiration rate and rate of deep breathing (sighs) before, during, and after hypnosis
Change in peripheral blood flow (pulse oximetry) before, during, and after hypnosis

Secondary Outcome Measures

Change in pain threshold temperature
Change in pain tolerance temperature
Change in heat pulse pain ratings

Full Information

First Posted
October 5, 2015
Last Updated
May 1, 2017
Sponsor
University of California, Los Angeles
Collaborators
Children's Hospital Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT02620488
Brief Title
A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
Official Title
A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Children's Hospital Los Angeles

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Pain Perception, Autonomic Nervous System, Sickle Cell Disease, Hypnosis, Guided Imagery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Control
Arm Type
Active Comparator
Arm Description
Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.
Arm Title
Sickle Cell Disease
Arm Type
Experimental
Arm Description
Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.
Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery
Intervention Description
Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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 Measure Information:
Title
Change in pain threshold temperature
Time Frame
12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session
Title
Change in pain tolerance temperature
Time Frame
9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session
Title
Change in heat pulse pain ratings
Time Frame
5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy control or with a diagnosis of sickle cell disease Age 13 or older African-American Subject is able to provide informed signed consent Subject is able to follow instructions Exclusion Criteria: Any known acute or chronic illness that in the judgment of the investigator, may compromise subject safety or data integrity Neurologic disorders affecting sensation Skin abnormality/abrasion over sites of stimulus Under 13 years of age Unable to follow instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lonnie K Zeltzer, MD
Organizational Affiliation
UCLA Pediatric Pain and Palliative Care Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs