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

Primary Purpose

Sickle Cell Disease, Pain Management

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hypnosis
Control
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Pain Management, Sickle Cell, Sickle Cell Disease, Pain, Hypnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • Howard University Hospital
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Hypnosis

Control

Outcomes

Primary Outcome Measures

Pain Assessment
Pain assessment using 0-10 scale

Secondary Outcome Measures

Face to Face assessment of psychosocial variables

Full Information

First Posted
October 26, 2006
Last Updated
October 28, 2021
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00393250
Brief Title
Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease
Official Title
Hypnosis as a Pain and Symptom Management Strategy in Patients With Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 30, 2007 (Actual)
Primary Completion Date
June 4, 2012 (Actual)
Study Completion Date
June 4, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Pain Management
Keywords
Pain Management, Sickle Cell, Sickle Cell Disease, Pain, Hypnosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Hypnosis
Arm Title
2
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Other
Intervention Name(s)
Hypnosis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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 Measure Information:
Title
Pain Assessment
Description
Pain assessment using 0-10 scale
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Face to Face assessment of psychosocial variables
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwenyth R Wallen, Ph.D.
Organizational Affiliation
National Institutes of Health Clinical Center (CC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11516052
Citation
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.
Results Reference
background
PubMed Identifier
12460456
Citation
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.
Results Reference
background
PubMed Identifier
12010077
Citation
Ballas SK. Sickle cell anaemia: progress in pathogenesis and treatment. Drugs. 2002;62(8):1143-72. doi: 10.2165/00003495-200262080-00003.
Results Reference
background
PubMed Identifier
25520557
Citation
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.
Results Reference
derived
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2007-CC-0011.html
Description
NIH Clinical Center Detailed Web Page

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

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