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

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Behavioral: Attention Control; Behavioral: Hypnosis

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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.

Other Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Study Chair: Lonnie K Zeltzer, MD, UCLA Pediatric Pain and Palliative Care Program

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Autonomic Nervous System; Hypnosis; Sickle Cell Disease; Adolescence
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: F32sarahmartin2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No