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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Behavioral: Guided Imagery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Control<br>Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery. | Behavioral: Guided Imagery<br>* Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.<br>|
| Experimental: Sickle Cell Disease<br>Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery. | Behavioral: Guided Imagery<br>* Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Perception, Autonomic Nervous System, Sickle Cell Disease, Hypnosis, Guided Imagery