Sickle Cell DiseasePhase 3NCT00393250
Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease
A Phase 3 study testing Hypnosis in people with Sickle Cell Disease and Pain Management, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Pain Management
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2007to 4 Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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>
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Howard University Hospital
Washington D.C., District of Columbia, 20060
About this study
Official title: Hypnosis as a Pain and Symptom Management Strategy in Patients With Sickle Cell Disease
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.
Read more
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.
Read the 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.
- Conditions
- Sickle Cell Disease, Pain Management
- Being tested
- Hypnosis, Control
- Keywords
- Pain Management, Sickle Cell, Sickle Cell Disease, Pain, Hypnosis
- Medical subject headings
- Anemia, Sickle Cell, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
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.
ControlOther
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hypnosis Receives: Other: Hypnosis |
| 2 | Active comparator | Control Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
Pain assessment using 0-10 scale
Measured: 12 weeks
Secondary outcomes (1)
Face to Face assessment of psychosocial variables
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study start30 Apr 2007
- Primary completion4 Jun 2012
- Study completion4 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gwenyth R Wallen, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393250
- Sponsor's protocol ID
- 070011
- Other IDs
- 07-CC-0011
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2006
- Last updated
- 29 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11516052Anbar 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.
PubMed 12460456Ballas SK. Sickle cell anaemia: progress in pathogenesis and treatment. Drugs. 2002;62(8):1143-72. doi: 10.2165/00003495-200262080-00003.
PubMed 12010077Wallen 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.
PubMed 25520557
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis as a Pain and Symptom Management Strategy in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00393250
- Acronym / sponsor ID
- 070011
- Conditions
- Sickle Cell Disease, Pain Management
- Keywords
- Pain Management, Sickle Cell, Sickle Cell Disease, Pain, Hypnosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 30 Apr 2007 (actual)
- Primary completion
- 4 Jun 2012 (actual)
- Study completion
- 4 Jun 2012 (actual)
- First posted
- 27 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: HypnosisHypnosis |
| 2 | Active comparator | Other: ControlControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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>
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosisSubjects 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. | Other | 1 |
| ControlSubjects 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 | Other | 2 |
Primary outcome
Pain Assessment
Time frame: 12 weeks
Pain assessment using 0-10 scale
1 secondary outcome
Face to Face assessment of psychosocial variables
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 11516052Anbar 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.
- Background: PubMed 12460456Anbar 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.
- Background: PubMed 12010077Ballas SK. Sickle cell anaemia: progress in pathogenesis and treatment. Drugs. 2002;62(8):1143-72. doi: 10.2165/00003495-200262080-00003.
- Derived from this study: PubMed 25520557Wallen 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenyth R Wallen, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypnosis in people with Sickle Cell Disease and Pain Management, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00393250, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.