Back to resultsLaboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypnosis
Attention Control
Sponsored by
About this trial
This is an interventional supportive care trial for Sickle Cell Disease focused on measuring Adolescence, Autonomic Nervous System, Hypnosis, Pain, Sickle Cell Disease
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.
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Attention Control
Hypnosis
Arm Description
Participants will listen to a 30-minute historical story.
Participants will receive a 30-minute hypnosis session
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
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.
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.
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.
Full Information
NCT ID
NCT02987725
First Posted
December 1, 2016
Last Updated
November 2, 2020
Sponsor
University of California, Los Angeles
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02987725
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Adolescence, Autonomic Nervous System, Hypnosis, Pain, Sickle Cell Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
Participants will listen to a 30-minute historical story.
Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
Participants will receive a 30-minute hypnosis session
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
A 30-minute historical story read by a research clinician.
Primary Outcome Measure Information:
Title
Change in peripheral blood flow before and during the intervention
Description
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).
Time Frame
Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
Secondary Outcome Measure Information:
Title
Change in pain threshold temperature
Description
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).
Time Frame
12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
Title
Change in pain tolerance temperature
Description
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).
Time Frame
9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
Title
Change in heat pulse pain intensity ratings
Description
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).
Time Frame
5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
Title
Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma
Description
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).
Time Frame
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
Title
Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma
Description
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.
Time Frame
12 minutes before the start of the intervention and 15 minutes after the start of the intervention
Title
Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma
Description
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.
Time Frame
9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
Title
Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma
Description
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.
Time Frame
5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
Other Pre-specified Outcome Measures:
Title
Change in the effect of the intervention on Skin Conductance Response (SCR)
Description
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).
Time Frame
12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
Title
Change in the effect of the intervention on Heart Rate Variability
Description
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).
Time Frame
12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lonnie K Zeltzer, MD
Organizational Affiliation
UCLA Pediatric Pain and Palliative Care Program
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
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