Sickle Cell DiseaseNCT02620488
A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
A study testing Guided Imagery in people with Sickle Cell Disease, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2015
- Phase
- Interventional
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
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.
- Conditions
- Sickle Cell Disease
- Being tested
- Guided Imagery
- Keywords
- Pain Perception, Autonomic Nervous System, Sickle Cell Disease, Hypnosis, Guided Imagery
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Active comparator | Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery. Receives: Behavioral: Guided Imagery |
| Sickle Cell Disease | Experimental | Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery. Receives: Behavioral: Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate variability (HRV) before, during, and after hypnosis
Measured: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
Change in galvanic skin response (GSR) before, during, and after hypnosis
Measured: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
Change in overall respiration rate and rate of deep breathing (sighs) before, during, and after hypnosis
Measured: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
Change in peripheral blood flow (pulse oximetry) before, during, and after hypnosis
Measured: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
Secondary outcomes (3)
Change in pain threshold temperature
Measured: 12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session
Change in pain tolerance temperature
Measured: 9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session
Change in heat pulse pain ratings
Measured: 5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Lonnie Zeltzer, University of California, Los Angeles
- Investigators
- Lonnie K Zeltzer, MD, Principal investigator, UCLA Pediatric Pain and Palliative Care Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620488
- Sponsor's protocol ID
- 15-000420
- Status last verified
- May 2017
- First submitted
- 5 Oct 2015
- Last updated
- 3 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02620488
- Acronym / sponsor ID
- 15-000420
- Conditions
- Sickle Cell Disease
- Keywords
- Pain Perception, Autonomic Nervous System, Sickle Cell Disease, Hypnosis, Guided Imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Dec 2015 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | Active comparator | Behavioral: Guided ImageryBrief guided imagery session with a trained clinician focused on relaxation and pleasant imagery. |
| Sickle Cell Disease | Experimental | Behavioral: Guided ImageryBrief guided imagery session with a trained clinician focused on relaxation and pleasant imagery. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Guided ImageryBrief guided imagery session with a trained clinician focused on relaxation and pleasant imagery. | Behavioural | Healthy Control, Sickle Cell Disease |
Primary outcome
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
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
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
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
3 secondary outcomes
Change in pain threshold temperature
Time frame: 12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session
Change in pain tolerance temperature
Time frame: 9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session
Change in heat pulse pain ratings
Time frame: 5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session
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 3 May 2017.
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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.
Lonnie K Zeltzer, MD principal investigator
UCLA Pediatric Pain and Palliative Care Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery in people with Sickle Cell Disease, run by University of California, Los Angeles at 1 site 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 5 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 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2017.