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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 : Completed
First Posted : December 9, 2016
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sarah R. Martin, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE December 1, 2016
First Posted Date  ICMJE December 9, 2016
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE March 16, 2018
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2016)
Change in peripheral blood flow before and during hypnosis [ Time Frame: Beginning 15 minutes prior to hypnosis session and continuing during 30 minutes of the hypnosis session. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2016)
  • Change in pain threshold temperature [ Time Frame: 12 minutes before the start of the hypnosis session and 15 minutes after the start of the hypnosis session. ]
  • Change in pain tolerance temperature [ Time Frame: 9 minutes before the start of the hypnosis session and 18 minutes after the start of the hypnosis session. ]
  • Change in heat pulse pain intensity ratings [ Time Frame: 5 minutes before the start of the hypnosis session and 21 minutes after the start of the hypnosis session. ]
  • Change in the effect of hypnosis on peripheral blood flow at different levels of disease-related stigma [ Time Frame: 15 minutes prior to the start of hypnosis to a minute before the start of hypnosis and from the start of hypnosis to 30 minutes after the start of hypnosis ]
    Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the and the change in effect, which is assessed by comparing levels of blood flow during the pre-hypnosis period (15 minutes prior to hypnosis to a minute before the start of hypnosis) from blood flow during the hypnosis period (from the start of hypnosis until 30 minutes after the start of hypnosis).
  • Change in the effect of hypnosis on pain threshold temperature at different levels of disease-related stigma [ Time Frame: 12 minutes before the start of the hypnosis session and 15 minutes after the start of the hypnosis session ]
    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 hypnosis session and 15 minutes after the start of the hypnosis session.
  • Change in the effect of hypnosis on pain tolerance temperature at different levels of disease-related stigma [ Time Frame: 9 minutes before the start of the hypnosis session and 18 minutes after the start of the hypnosis session. ]
    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 hypnosis session and 18 minutes after the start of the hypnosis session.
  • Change in the effect of hypnosis on heat pulse pain intensity ratings at different levels of disease-related stigma [ Time Frame: 5 minutes before the start of the hypnosis session and 21 minutes after the start of the hypnosis session. ]
    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 hypnosis session and 21 minutes after the start of the hypnosis session.
Current Other Pre-specified Outcome Measures
 (submitted: September 25, 2018)
  • 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).
  • 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).
Original Other Pre-specified Outcome Measures
 (submitted: December 6, 2016)
  • Change in the effect of hypnosis on Skin Conductance Response (SCR) [ Time Frame: 12-5 minutes prior to the start of hypnosis and 15-21 minutes after the start of hypnosis ]
  • Change in the effect of hypnosis on Heart Rate Variability [ Time Frame: 12-5 minutes prior to the start of hypnosis and 15-21 minutes after the start of hypnosis ]
 
Descriptive Information
Brief Title  ICMJE Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
Official Title  ICMJE Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Behavioral: Hypnosis
    A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.
  • Behavioral: Attention Control
    A 30-minute historical story read by a research clinician.
Study Arms  ICMJE
  • Active Comparator: Attention Control
    Participants will listen to a 30-minute historical story.
    Intervention: Behavioral: Attention Control
  • Experimental: Hypnosis
    Participants will receive a 30-minute hypnosis session
    Intervention: Behavioral: Hypnosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2020)
25
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2016)
50
Actual Study Completion Date  ICMJE November 1, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02987725
Other Study ID Numbers  ICMJE F32sarahmartin2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sarah R. Martin, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Study Chair: Lonnie K Zeltzer, MD UCLA Pediatric Pain and Palliative Care Program
PRS Account University of California, Los Angeles
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP