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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Control | Active Comparator | Participants will listen to a 30-minute historical story. |
|
| Hypnosis | Experimental | Participants will receive a 30-minute hypnosis session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis | Behavioral | A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripheral blood flow before and during the intervention | Peripheral blood flow will be measured using continuous readings of oxygen saturation, pulse rate, and pulse waveform from the thumb and change in blood flow will be assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention). | Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain threshold temperature | Pain threshold temperature will be determined by when participants report they first feel pain and change in pain threshold temperature will be assessed by comparing pain threshold temperature during the pre-intervention period (12 minutes before the start of the intervention) from pain threshold temperature during the intervention period (15 minutes after the start of the intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the effect of the intervention on Skin Conductance Response (SCR) | Skin Conductance Response (SCR) will be measured using continuous readings of electrical properties of the skin on the index finger and change in SCR will be assessed by comparing levels of SCR during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from SCR during the intervention period (15-21 minutes after the start of the intervention). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lonnie K Zeltzer, MD | UCLA Pediatric Pain and Palliative Care Program | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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| Attention Control | Behavioral | A 30-minute historical story read by a research clinician. |
|
| 12 minutes before the start of the intervention and 15 minutes after the start of the intervention. |
| Change in pain tolerance temperature | Pain tolerance temperature will be determined by when participants report they can no longer tolerate the pain and change in pain tolerance temperature will be assessed by comparing pain tolerance temperature during the pre-intervention period (9 minutes before the start of the intervention) from pain tolerance temperature during the intervention period (18 minutes after the start of the intervention). | 9 minutes before the start of the intervention and 18 minutes after the start of the intervention. |
| Change in heat pulse pain intensity ratings | Heat pulse pain intensity ratings will be determined by participants' self-report of heat pulse pain intensity (rated on a 0-10 scale, with 0 being no pain and 10 being worst pain), and change in heat pulse pain intensity will be assessed by comparing pain tolerance temperature during the pre-intervention period (5 minutes before the start of the intervention) from heat pulse pain intensity during the intervention period (21 minutes after the start of the intervention). | 5 minutes before the start of the intervention and 21 minutes after the start of the intervention. |
| Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma | Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention). | 15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention |
| Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma | Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain threshold collected 12 minutes before the start of the intervention and 15 minutes after the start of the intervention. | 12 minutes before the start of the intervention and 15 minutes after the start of the intervention |
| Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma | Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain tolerance collected 9 minutes before the start of the intervention and 18 minutes after the start of the intervention. | 9 minutes before the start of the intervention and 18 minutes after the start of the intervention. |
| Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma | Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain intensity collected 5 minutes before the start of the intervention and 21 minutes after the start of the intervention. | 5 minutes before the start of the intervention and 21 minutes after the start of the intervention. |
| 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention |
| Change in the effect of the intervention on Heart Rate Variability | Heart Rate Variability (HRV) will be measured using continuous readings of heartbeat intervals and change in HRV will be assessed by comparing HRV during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from HRV during the intervention period (15-21 minutes after the start of the intervention). | 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |