Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00393250
First received: October 26, 2006
Last updated: May 8, 2014
Last verified: April 2014
  Purpose

This study will examine whether hypnosis can reduce the frequency and intensity of pain in patients with sickle cell disease.

Patients 18 years of age and older with sickle cell disease and a history of pain associated with their disease may be eligible for this study.

Participants are interviewed to assess their frequency and intensity of pain, sleep quality, coping strategies, mood and anxiety and are then randomly assigned to study Group A or B (see below). All participants are given pain diaries to complete at home and turn in at each clinic visit. They undergo the following procedures:

Group A

Weeks 1-4: Receive weekly 60-minute hypnosis sessions, in which they are given suggestions for relieving pain, reducing anxiety, improving sleep and enhancing their health and well-being. The sessions are audio- and videotaped.

Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.

Week 6: Receive a DVD player and DVD with instruction on how to perform self-hypnosis. They practice hypnosis at home as often as needed, but at least once a day. They record in a pain diary in the morning and the evening their amount of pain, medication use, school or work attendance, quality and amount of sleep and number of times they use self-hypnosis.

Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.

Week 12: Are assessed for how they respond to the hypnosis.

Group B

Weeks 1-4: Receive weekly 60-minute sessions of education about sickle cell disease.

Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.

Week 6: Turn in their daily pain diaries and receive a DVD player and DVD that contains educational materials about sickle cell disease.

Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.

Weeks 13-24: Follow the procedures described in weeks 1-12 for Group A.


Condition Intervention Phase
Sickle Cell Disease
Behavioral: Hypnosis
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Hypnosis as a Pain and Symptom Management Strategy in Patients With Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Subjects' diary reports of pain severity and pain intensity as measured by the pain numerical rating scale during follow-up clinic assessments.

Enrollment: 31
Study Start Date: October 2006
Study Completion Date: June 2012
Intervention Details:
    Behavioral: Hypnosis
    N/A
Detailed Description:

Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Standard medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. Published studies focus on the frequency of acute pain crises resulting in emergency department use and a number of hospitalizations. However, few studies focus on pain manifestations outside the typical healthcare delivery system. Furthermore, the proportion of patients who are able to self-manage their crises at home without accessing healthcare professionals is unknown. Adjunctive approaches using psychosocial interventions may be effective in further reducing and/or preventing painful crises, as well as in improving quality of life and reducing health care utilization. Recent evidence suggests that learning a cognitive-behavioral intervention centered on self-hypnosis for pain management may be helpful in modulating pain frequency, improving sleep quality, and decreasing use of narcotic pain medications in patients with SCD.

This protocol describes a randomized, controlled, single-crossover, single-blinded pilot study trial of hypnosis for managing pain in SCD patients. Subjects receive hypnosis (experimental intervention) during 4 weeks of face-to-face encounters with a physician trained in hypnosis. For 6 weeks following the instruction period, the participants will perform daily self-hypnosis using customizable digital media. Subjects in the control arm of the study will receive face-to-face education regarding sickle cell disease for the same length and frequency as the treatment group hypnosis encounters before crossing over to the experimental intervention arm of the study. Primary outcome measures include patient assessments of pain frequency, intensity, and quality. Secondary outcome measures include face-to face assessments of psychosocial variables including anxiety, coping strategies, sleep, depression and health-care utilization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • ELIGIBILITY:

Subjects with known or suspected sickle cell disease are eligible to participate in this study.

INCLUSION CRITERIA:

Greater than or equal to 18 years of age.

Diagnosis of Hemoglobin SS sickle cell disease.

Patient identifies history of pain as a significant problem during at least 2 days in the month prior to enrollment.

Written informed consent/assent has been obtained.

< TAB>

EXCLUSION CRITERIA:

Less than 18 years of age.

Unwilling to experience hypnosis or to have hetero-hypnosis sessions recorded.

Non-fluency in written and spoken English.

Physical or other disabilities that prevent adequate participation in hypnotic susceptibility testing.

Does not wish to be video and audiotaped.

Psychosis or psychotic depression.

History of seizures or epilepsy.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393250

Locations
United States, District of Columbia
Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Gwenyth R Wallen, Ph.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00393250     History of Changes
Other Study ID Numbers: 070011, 07-CC-0011
Study First Received: October 26, 2006
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Hypnosis
Symptom Management
Pain Management
Sickle Cell Disease
Pain

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 01, 2014