Clinical trial NCT02987725: Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
Official title: Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Adolescence
Autonomic Nervous System
Hypnosis
Pain
Sickle Cell Disease
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-12-09
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of sickle cell disease
* Age 12-21 years old
* Fluent in English (the intervention will be delivered in English)
* Participant is cognitively able to provide informed signed consent or assent
* Participant is cognitively able to follow instructions

Exclusion Criteria:

* Under 12 years of age or over 21 years of age
* Not fluent in English
* Pain medication prescription has changed or if they have been hospitalized for a vaso-occlusive episode within 30 days of study participation.
* Diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation, skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic heart disease) or cognitive impairment that may affect data integrity or the ability to complete study procedures.

Primary outcomes:
measure: Change in peripheral blood flow before and during the intervention
timeFrame: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
Secondary outcomes:
measure: Change in pain threshold temperature
timeFrame: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
measure: Change in pain tolerance temperature
timeFrame: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
measure: Change in heat pulse pain intensity ratings
timeFrame: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
measure: Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma
timeFrame: 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
measure: Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma
timeFrame: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention
measure: Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma
timeFrame: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
measure: Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma
timeFrame: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
Other outcomes:
measure: Change in the effect of the intervention on Skin Conductance Response (SCR)
timeFrame: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
measure: Change in the effect of the intervention on Heart Rate Variability
timeFrame: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: UCLA Pediatric Pain and Palliative Care Program
name: Lonnie K Zeltzer, MD
role: STUDY_CHAIR
References: