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

NCT02987725 | Completed

• 1 other identifier: F32sarahmartin2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Adolescence; Autonomic Nervous System; Hypnosis; Pain; Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in pain threshold temperature

  12 minutes before the start of the intervention and 15 minutes after the start of the intervention.

• Change in pain tolerance temperature

  9 minutes before the start of the intervention and 18 minutes after the start of the intervention.

• Change in heat pulse pain intensity ratings

  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

  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

  12 minutes before the start of the intervention and 15 minutes after the start of the intervention

Other Outcomes (2)

• Change in the effect of the intervention on Skin Conductance Response (SCR)

  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

  12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention

Study Arms (2)

Attention Control

ACTIVE COMPARATOR

Participants will listen to a 30-minute historical story.

Behavioral: Attention Control

Hypnosis

EXPERIMENTAL

Participants will receive a 30-minute hypnosis session

Behavioral: Hypnosis

Interventions

Hypnosis BEHAVIORAL

A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.

Hypnosis

Attention Control BEHAVIORAL

A 30-minute historical story read by a research clinician.

Attention Control

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lonnie K Zeltzer, MD

  UCLA Pediatric Pain and Palliative Care Program

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 9, 2016
• Study Start: March 16, 2018
• Primary Completion: June 30, 2020
• Study Completion: November 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (1)