NCT02620488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

October 5, 2015

Last Update Submit

May 1, 2017

Conditions

Sickle Cell Disease

Keywords

Pain PerceptionAutonomic Nervous SystemSickle Cell DiseaseHypnosisGuided Imagery

Outcome Measures

Primary Outcomes (4)

  • Change in heart rate variability (HRV) before, during, and after hypnosis

    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

    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

    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

    Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session

Secondary Outcomes (3)

  • Change in pain threshold temperature

    12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session

  • Change in pain tolerance temperature

    9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session

  • Change in heat pulse pain ratings

    5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session

Study Arms (2)

Healthy Control

ACTIVE COMPARATOR

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

Behavioral: Guided Imagery

Sickle Cell Disease

EXPERIMENTAL

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

Behavioral: Guided Imagery

Interventions

Guided ImageryBEHAVIORAL

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

Healthy ControlSickle Cell Disease

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lonnie K Zeltzer, MD

    UCLA Pediatric Pain and Palliative Care Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Pediatrics, Anesthesiology, Psychiatry and Biobehavioral Sciences

Study Record Dates

First Submitted

October 5, 2015

First Posted

December 3, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

US(1)