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Completed

NCT Number: NCT02620488

A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease

This pilot study will assess the effects of a brief laboratory-based guided imagery procedure on responses to pain in patients with sickle cell disease (SCD) and healthy controls.

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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

Age range

13 year and older

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: Yes

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

Inclusion criteria

  • Healthy control or with a diagnosis of sickle cell disease
  • Age 13 or older
  • African-American
  • Subject is able to provide informed signed consent
  • Subject is able to follow instructions

Exclusion criteria

  • Any known acute or chronic illness that in the judgment of the investigator, may compromise subject safety or data integrity
  • Neurologic disorders affecting sensation
  • Skin abnormality/abrasion over sites of stimulus
  • Under 13 years of age
  • Unable to follow instructions

Treatment and study plan

GUIDED IMAGERY

Behavioral

Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.

Primary outcomes

  1. Change in heart rate variability (HRV) before, during, and after hypnosis

    Time frame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session

  2. Change in galvanic skin response (GSR) before, during, and after hypnosis

    Time frame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session

  3. Change in overall respiration rate and rate of deep breathing (sighs) before, during, and after hypnosis

    Time frame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session

  4. Change in peripheral blood flow (pulse oximetry) before, during, and after hypnosis

    Time frame: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session

Secondary outcomes

  1. Change in pain threshold temperature

    Time frame: 12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session

  2. Change in pain tolerance temperature

    Time frame: 9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session

  3. Change in heat pulse pain ratings

    Time frame: 5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Children's Hospital Los Angeles

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2015
Registry last updated
May 3, 2017

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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