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

NCT00393250 | Completed Phase 3

• 2 other identifiers: 07001107-CC-0011
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sickle Cell Disease; Pain Management

Keywords

Pain Management; Sickle Cell; Sickle Cell Disease; Pain; Hypnosis

Outcome Measures

Primary Outcomes (1)

• Pain Assessment

  Pain assessment using 0-10 scale

  12 weeks

Secondary Outcomes (1)

• Face to Face assessment of psychosocial variables

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Hypnosis

Other: Hypnosis

2

ACTIVE COMPARATOR

Control

Other: Control

Interventions

Hypnosis OTHER

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.

1

Control OTHER

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\>

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (2)

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Anbar RD. Self-hypnosis for the treatment of functional abdominal pain in childhood. Clin Pediatr (Phila). 2001 Aug;40(8):447-51. doi: 10.1177/000992280104000804.

  PMID: 11516052 BACKGROUND

• Anbar RD. Hypnosis in pediatrics: applications at a pediatric pulmonary center. BMC Pediatr. 2002 Dec 3;2:11. doi: 10.1186/1471-2431-2-11. Epub 2002 Dec 3.

  PMID: 12460456 BACKGROUND

• Ballas SK. Sickle cell anaemia: progress in pathogenesis and treatment. Drugs. 2002;62(8):1143-72. doi: 10.2165/00003495-200262080-00003.

  PMID: 12010077 BACKGROUND

• Wallen GR, Middleton KR, Ames N, Brooks AT, Handel D. Randomized trial of hypnosis as a pain and symptom management strategy in adults with sickle cell disease. Integr Med Insights. 2014 Nov 3;9:25-33. doi: 10.4137/IMI.S18355. eCollection 2014.

  PMID: 25520557 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Anemia, Sickle Cell; Agnosia; 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; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gwenyth R Wallen, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 27, 2006
• Study Start: April 30, 2007
• Primary Completion: June 4, 2012
• Study Completion: June 4, 2012
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (2)