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Completed

NCT Number: NCT02987725

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.

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Key information

Conditions

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

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hypnosis

Behavioral

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

Attention Control

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2016
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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