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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620488
• Other study ID #: 15-000420
• Status: Completed
• Phase: N/A
• First received: October 5, 2015
• Last updated: May 1, 2017
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Behavioral:
• Guided Imagery
Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in pain threshold temperature		12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session
Secondary	Change in pain tolerance temperature		9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session
Secondary	Change in heat pulse pain ratings		5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session