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

NCT ID: NCT02987725

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2020-11-01

Brief Summary

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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

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Attention Control

Participants will listen to a 30-minute historical story.

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

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

Hypnosis

Participants will receive a 30-minute hypnosis session

Group Type EXPERIMENTAL

Hypnosis

Intervention Type BEHAVIORAL

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

Interventions

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Hypnosis

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

Attention Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Sarah R. Martin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lonnie K Zeltzer, MD

Role: STUDY_CHAIR

UCLA Pediatric Pain and Palliative Care Program

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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F32sarahmartin2

Identifier Type: -

Identifier Source: org_study_id