Sickle Cell DiseaseNCT02987725
Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
A study testing Hypnosis in people with Sickle Cell Disease, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may… Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 1 Nov 2020
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A diagnosis of sickle cell disease
- Age 12-21 years old
- Fluent in English (the intervention will be delivered in English)
- Participant is cognitively able to provide informed signed consent or assent
- Participant is cognitively able to follow instructions
Who cannot join
- Under 12 years of age or over 21 years of age
- Not fluent in English
- Pain medication prescription has changed or if they have been hospitalized for a vaso-occlusive episode within 30 days of study participation.
- Diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation, skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic heart disease) or cognitive impairment that may affect data integrity or the ability to complete study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
The purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.
- Conditions
- Sickle Cell Disease
- Being tested
- Hypnosis, Attention Control
- Keywords
- Adolescence, Autonomic Nervous System, Hypnosis, Pain, Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.
Attention ControlBehavioural
A 30-minute historical story read by a research clinician.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Active comparator | Participants will listen to a 30-minute historical story. Receives: Behavioral: Attention Control |
| Hypnosis | Experimental | Participants will receive a 30-minute hypnosis session Receives: Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral blood flow before and during the intervention
Peripheral blood flow will be measured using continuous readings of oxygen saturation, pulse rate, and pulse waveform from the thumb and change in blood flow will be assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
Measured: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
Secondary outcomes (7)
Change in pain threshold temperature
Pain threshold temperature will be determined by when participants report they first feel pain and change in pain threshold temperature will be assessed by comparing pain threshold temperature during the pre-intervention period (12 minutes before the start of the intervention) from pain threshold temperature during the intervention period (15 minutes after the start of the intervention).
Measured: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
Change in pain tolerance temperature
Pain tolerance temperature will be determined by when participants report they can no longer tolerate the pain and change in pain tolerance temperature will be assessed by comparing pain tolerance temperature during the pre-intervention period (9 minutes before the start of the intervention) from pain tolerance temperature during the intervention period (18 minutes after the start of the intervention).
Measured: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
Change in heat pulse pain intensity ratings
Heat pulse pain intensity ratings will be determined by participants' self-report of heat pulse pain intensity (rated on a 0-10 scale, with 0 being no pain and 10 being worst pain), and change in heat pulse pain intensity will be assessed by comparing pain tolerance temperature during the pre-intervention period (5 minutes before the start of the intervention) from heat pulse pain intensity during the intervention period (21 minutes after the start of the intervention).
Measured: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma
Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
Measured: 15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention
Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma
Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain threshold collected 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
Measured: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention
Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma
Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain tolerance collected 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
Measured: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma
Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain intensity collected 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
Measured: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start16 Mar 2018
- Primary completion30 Jun 2020
- Study completion1 Nov 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sarah R. Martin, University of California, Los Angeles
- Investigators
- Lonnie K Zeltzer, MD, Study chair, UCLA Pediatric Pain and Palliative Care Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987725
- Sponsor's protocol ID
- F32sarahmartin2
- Status last verified
- Nov 2020
- First submitted
- 1 Dec 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02987725
- Acronym / sponsor ID
- F32sarahmartin2
- Conditions
- Sickle Cell Disease
- Keywords
- Adolescence, Autonomic Nervous System, Hypnosis, Pain, Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 9 Dec 2016 (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.
The purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Active comparator | Behavioral: Attention ControlParticipants will listen to a 30-minute historical story. |
| Hypnosis | Experimental | Behavioral: HypnosisParticipants will receive a 30-minute hypnosis session |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- A diagnosis of sickle cell disease
- Age 12-21 years old
- Fluent in English (the intervention will be delivered in English)
- Participant is cognitively able to provide informed signed consent or assent
- Participant is cognitively able to follow instructions
Key exclusion criteria (4 listed)
- Under 12 years of age or over 21 years of age
- Not fluent in English
- Pain medication prescription has changed or if they have been hospitalized for a vaso-occlusive episode within 30 days of study participation.
- Diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation, skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic heart disease) or cognitive impairment that may affect data integrity or the ability to complete study procedures.
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 |
|---|---|---|
| HypnosisA 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses. | Behavioural | Hypnosis |
| Attention ControlA 30-minute historical story read by a research clinician. | Behavioural | Attention Control |
Primary outcome
Change in peripheral blood flow before and during the intervention
Time frame: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
Peripheral blood flow will be measured using continuous readings of oxygen saturation, pulse rate, and pulse waveform from the thumb and change in blood flow will be assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
7 secondary outcomes
Change in pain threshold temperature
Time frame: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
Change in pain tolerance temperature
Time frame: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
Change in heat pulse pain intensity ratings
Time frame: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma
Time frame: 15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention
Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma
Time frame: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention
Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma
Time frame: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma
Time frame: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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 4 Nov 2020.
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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 study chair
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 Hypnosis 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 4 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 4 Nov 2020. 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 peripheral blood flow before and during the intervention (time frame: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention). 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 4 Nov 2020.