Sickle Cell CrisisNCT05572294
Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease
A study testing Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy in people with Sickle Cell Crisis and Sickle Cell Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Patients with sickle cell disease suffer from acute and chronic pain that diminishes their quality of life. The purpose of this study is to assess the feasibility and acceptability of mindfulness meditation, breathing exercises, and gentle yoga therapy as supportive measures for the management of acute vaso-occlusive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Crisis, Sickle Cell Disease
- What is being tested?
- Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 2 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sickle cell disease, any genotype
- Adult patients at least 18 years of age
- English speaking
- Admitted to Clements University Hospital with an acute vaso-occlusive pain crisis
Who cannot join
- Unable to follow simple instructions
- Admitted to the intensive care unit
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Patients with sickle cell disease suffer from acute and chronic pain that diminishes their quality of life. The purpose of this study is to assess the feasibility and acceptability of mindfulness meditation, breathing exercises, and gentle yoga therapy as supportive measures for the management of acute vaso-occlusive pain crises in the inpatient setting.
Read the detailed description
This is a prospective single arm study of mindfulness interventions for sickle cell patients admitted with an acute vaso-occlusive pain crisis. Patients will be accrued over a consecutive 12 week period. All genotypes of sickle cell disease will be eligible for enrollment.
After providing informed consent, the patients will have access to 4 videos on their hospital room television. The videos contain guided mindfulness meditation, breathing exercises (including the use of an incentive spirometer), and gentle yoga therapy that can be performed in the supine position from a hospital bed. Videos vary in length from 5-12 minutes. Participants will have the ability to watch the videos as many times as they choose. They may also turn off the video at any time.
The primary outcome is feasibility and acceptability of the intervention. We will record objective data on how many videos are watched by each participant, as well as the percentage of each video completed. We will obtain information about the participants' perception of the intervention through a post-intervention survey and interview.
- Conditions
- Sickle Cell Crisis, Sickle Cell Disease
- Being tested
- Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy
- Keywords
- Sickle Cell Disease, Yoga Therapy, Mindfulness
- Medical subject headings
- Vaso-Occlusive Crises, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapyBehavioural
Sickle cell patients admitted with a vaso-occlusive pain crisis over a consecutive 12-week period will be offered participation in the study. After providing informed consent, participants will have access to 4 videos containing guided mindfulness meditation, breathing exercises, and gentle yoga therapy. The videos are 5-12 minutes long and taught by a physical therapist who is also certified in yoga therapy. Participants may turn off the video at any time. Participants will have access to the videos for the duration of their hospitalization, and they may watch the videos as many times as they desire.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness and Yoga Therapy | Experimental | Participants will have access to video-guided mindfulness interventions. Receives: Behavioral: Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention as measured by the proportion of sickle cell patients admitted over a consecutive 12 week time period who agree to participate in the study
Measured: 12 weeks
Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization
Measured: 12 weeks
Acceptability of the intervention as measured by the proportion of participants who found the mindfulness practices enjoyable and/or helpful
This data will be collected via a post-intervention survey and interview. The survey will contain simple questions with yes/no answer options. The interview will be conducted by a study member, either in-person or by telephone.
Measured: at the time of hospital discharge, up to 6 months post-intervention
Acceptability of the intervention as measured by the proportion of participants who are interested in pursuing mindfulness therapies in the future
This data will be collected via a post-intervention survey and interview. The survey will contain simple questions with yes/no answer options. The interview will be conducted by a study member, either in-person or by telephone.
Measured: at the time of hospital discharge, up to 6 months post-intervention
Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalization
Measured: at the time of hospital discharge, up to 6 months post-intervention
Participant engagement as measured by the percentage of videos completed. A video is considered completed if the participant watches more than 85% of the video.
Measured: at the time of hospital discharge, up to 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start10 Nov 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell CrisisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siayareh Rambally, University of Texas Southwestern Medical Center
- Investigators
- Siayareh Rambally, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572294
- Sponsor's protocol ID
- STU-2021-0729
- Status last verified
- Feb 2023
- First submitted
- 19 Sep 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05572294
- Acronym / sponsor ID
- STU-2021-0729
- Conditions
- Sickle Cell Crisis, Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Yoga Therapy, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 7 Oct 2022 (actual)
- 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.
Patients with sickle cell disease suffer from acute and chronic pain that diminishes their quality of life. The purpose of this study is to assess the feasibility and acceptability of mindfulness meditation, breathing exercises, and gentle yoga therapy as supportive measures for the management of acute vaso-occlusive pain crises in the inpatient setting.
Detailed description
This is a prospective single arm study of mindfulness interventions for sickle cell patients admitted with an acute vaso-occlusive pain crisis. Patients will be accrued over a consecutive 12 week period. All genotypes of sickle cell disease will be eligible for enrollment.
After providing informed consent, the patients will have access to 4 videos on their hospital room television. The videos contain guided mindfulness meditation, breathing exercises (including the use of an incentive spirometer), and gentle yoga therapy that can be performed in the supine position from a hospital bed. Videos vary in length from 5-12 minutes. Participants will have the ability to watch the videos as many times as they choose. They may also turn off the video at any time.
The primary outcome is feasibility and acceptability of the intervention. We will record objective data on how many videos are watched by each participant, as well as the percentage of each video completed. We will obtain information about the participants' perception of the intervention through a post-intervention survey and interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and Yoga Therapy | Experimental | Behavioral: Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapyParticipants will have access to video-guided mindfulness interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with sickle cell disease, any genotype
- Adult patients at least 18 years of age
- English speaking
- Admitted to Clements University Hospital with an acute vaso-occlusive pain crisis
Key exclusion criteria (2 listed)
- Unable to follow simple instructions
- Admitted to the intensive care unit
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 |
|---|---|---|
| Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapySickle cell patients admitted with a vaso-occlusive pain crisis over a consecutive 12-week period will be offered participation in the study. After providing informed consent, participants will have access to 4 videos containing guided mindfulness meditation, breathing exercises, and gentle yoga therapy. The videos are 5-12 minutes long and taught by a physical therapist who is also certified in yoga therapy. Participants may turn off the video at any time. Participants will have access to the videos for the duration of their hospitalization, and they may watch the videos as many times as they desire. | Behavioural | Mindfulness and Yoga Therapy |
Primary outcome
Feasibility of the intervention as measured by the proportion of sickle cell patients admitted over a consecutive 12 week time period who agree to participate in the study
Time frame: 12 weeks
Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization
Time frame: 12 weeks
Acceptability of the intervention as measured by the proportion of participants who found the mindfulness practices enjoyable and/or helpful
Time frame: at the time of hospital discharge, up to 6 months post-intervention
This data will be collected via a post-intervention survey and interview. The survey will contain simple questions with yes/no answer options. The interview will be conducted by a study member, either in-person or by telephone.
Acceptability of the intervention as measured by the proportion of participants who are interested in pursuing mindfulness therapies in the future
Time frame: at the time of hospital discharge, up to 6 months post-intervention
This data will be collected via a post-intervention survey and interview. The survey will contain simple questions with yes/no answer options. The interview will be conducted by a study member, either in-person or by telephone.
Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalization
Time frame: at the time of hospital discharge, up to 6 months post-intervention
Participant engagement as measured by the percentage of videos completed. A video is considered completed if the participant watches more than 85% of the video.
Time frame: at the time of hospital discharge, up to 6 months post-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 13 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Crisis
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
RecruitingPhase 2
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Sickle Cell Disease
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
Active, not recruitingObservational study
Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease
Sickle Cell Anemia, Sickle Cell Thalassemia
RecruitingObservational study
Natural History of Sickle Cell Disease
Pain Crisis
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.
Siayareh Rambally, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy in people with Sickle Cell Crisis and Sickle Cell Disease, run by University of Texas Southwestern Medical Center 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 4 inclusion and 2 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 13 Feb 2023. 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?
Feasibility of the intervention as measured by the proportion of sickle cell patients admitted over a consecutive 12 week time period who agree to participate in the study (time frame: 12 weeks). The study lists 6 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 13 Feb 2023.