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

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Behavioral: Guided Imagery

• Registration Number: NCT02620488
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-11-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Posted: 2015-12-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Control	Guided Imagery	Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.
Sickle Cell Disease	Guided Imagery	Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.

Primary Outcome Measures

Name	Time	Method
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 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
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

Secondary Outcome Measures

Name	Time	Method
Change in pain tolerance temperature	9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session
Change in pain threshold temperature	12 minutes before beginning of hypnosis session and 1 minute 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

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States