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Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02987725
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sarah R. Martin, University of California, Los Angeles

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 12-18) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Hypnosis Behavioral: Attention Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Attention Control
Participants will listen to a 30-minute historical story.
Behavioral: Attention Control
A 30-minute historical story read by a research clinician.

Experimental: Hypnosis
Participants will receive a 30-minute hypnosis session
Behavioral: Hypnosis
A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.




Primary Outcome Measures :
  1. Change in peripheral blood flow before and during the intervention [ Time Frame: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of 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 :
  1. Change in pain threshold temperature [ Time Frame: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention. ]
    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).

  2. Change in pain tolerance temperature [ Time Frame: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention. ]
    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).

  3. Change in heat pulse pain intensity ratings [ Time Frame: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention. ]
    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).

  4. Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma [ 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 ]
    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).

  5. Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma [ Time Frame: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention ]
    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.

  6. Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma [ Time Frame: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention. ]
    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.

  7. Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma [ Time Frame: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention. ]
    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.


Other Outcome Measures:
  1. Change in the effect of the intervention on Skin Conductance Response (SCR) [ Time Frame: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention ]
    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).

  2. Change in the effect of the intervention on Heart Rate Variability [ Time Frame: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention ]
    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).



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of sickle cell disease
  • Age 12-18 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 18 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987725


Contacts
Contact: Sarah R Martin, PhD 310-500-8680 srmartin@mednet.ucla.edu
Contact: Lonnie K Zelzter, MD 310-825-0731 lzeltzer@mednet.ucla.edu

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Sarah R Martin, PhD    310-825-6964    srmartin@mednet.ucla.edu   
Contact: Lonnie K Zeltzer, MD    3108250731    lzeltzer@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Lonnie K Zeltzer, MD UCLA Pediatric Pain and Palliative Care Program

Responsible Party: Sarah R. Martin, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02987725     History of Changes
Other Study ID Numbers: F32sarahmartin2
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sarah R. Martin, University of California, Los Angeles:
Adolescence
Autonomic Nervous System
Hypnosis
Pain
Sickle Cell Disease

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn