Hematopoietic and Lymphatic System NeoplasmNCT06949943
Pre-Operative Guided Meditation to Reduce Pre-Operative Anxiety in Patients Undergoing Cancer-Directed Surgery
A study testing Behavioral Intervention, Electronic Health Record Review and Survey Administration in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial tests how well guided meditation, compared to silence, works to reduce pre-operative anxiety in patients undergoing cancer-directed surgery. Pre-operative anxiety affects patient experience and has been found to be a predictor of severe post-operative pain and chronic pain after surgery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Behavioral Intervention, Electronic Health Record Review and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants will be recruited among patients who are scheduled for cancer-directed surgery
- Participants must be 18 years or older
Who cannot join
- Participants will be excluded from the study if they cannot speak English (as the meditation is recorded in English)
- Currently incarcerated
- Have a diagnosis of dementia
- Are admitted to the intensive care unit (ICU)
- Have a hearing impairment that would make them unable to hear the recorded meditation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Maryanna Klatt, PhD, 614-366-1056, Maryanna.Klatt@Osumc.edu
Maryanna Klatt, PhD
About this study
Official title: Enhancing Quality of Patient Experience Via an Innovative Reduction of Pre-Operative Anxiety
This clinical trial tests how well guided meditation, compared to silence, works to reduce pre-operative anxiety in patients undergoing cancer-directed surgery. Pre-operative anxiety affects patient experience and has been found to be a predictor of severe post-operative pain and chronic pain after surgery, influencing the success and quality of a patient's recovery. While medication is often prescribed to improve anxiety symptoms, research has showed that mindfulness techniques can be used to decrease anxiety, improve comfort, and can impact both psychological and physiologic symptoms. Completing pre-operative guided meditation may work well to reduce pre-operative anxiety in patients undergoing cancer directive surgery.
Read the detailed description
PRIMARY OBJECTIVE:
- To improve is pre-operative patient anxiety in surgical settings.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients listen to 10 minutes of guided meditation prior to surgery.
ARM II: Patients wear noise cancelling headphones for 10 minutes prior to surgery.
After completion of study intervention, patients are followed up for up to 6 months.
- Being tested
- Behavioral Intervention, Electronic Health Record Review, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Listen to guided meditation
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Wear noise cancelling headphones
Electronic Health Record ReviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (guided meditation) | Experimental | Patients listen to 10 minutes of guided meditation prior to surgery. Receives: Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Survey Administration |
| Arm II (noise cancelling headphones) | Active comparator | Patients wear noise cancelling headphones for 10 minutes prior to surgery. Receives: Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative anxiety (PROMIS Anxiety scale)
Measured with the Patient Reported Outcome Measurement Information System Anxiety. PROMIS Anxiety short form is an 8-item scale used to assess anxiety in individuals 18 years or older. Each item is on a 5-point scale to be summed, with higher scores indicating greater anxiety.
Measured: Pre and post intervention, approximately 10 minutes
Pre-operative anxiety (single-item visual analog scale)
Measured by a single-item visual analog scale. The single-item visual analog scale will be used to assess momentary anxiety. The item will ask, "On a scale of 1 to 10, how anxious do you feel right now?" and patients will rate the level of anxiety on a scale of 0 to 10 (0=not at all anxious, 10=extremely anxious).
Measured: Pre and post intervention, approximately 10 minutes
Secondary outcomes (4)
Post-operative opiate use
Will be extracted from the electronic medical record via chart review. Days of opioid use will be calculated and compared between intervention and control groups.
Measured: Up to 6 months post intervention
Post-operative morphine equivalent dose
Will be extracted from the electronic medical record via chart review. Daily morphine equivalent dose for each opioid prescribed will be calculated and compared between intervention and control groups.
Measured: Up to 6 months post intervention
Post-operative average daily morphine
Will be extracted from the electronic medical record via chart review. Average daily morphine equivalent dose will be calculated and compared between intervention and control groups.
Measured: Up to 6 months post intervention
Length of stay
Will be extracted from the electronic medical record via chart review.
Measured: 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 posted29 Apr 2025
- Study start14 Mar 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryanna Klatt, Ohio State University Comprehensive Cancer Center
- Investigators
- Maryanna Klatt, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949943
- Sponsor's protocol ID
- OSU-24146
- Other IDs
- NCI-2025-01389
- Status last verified
- May 2026
- First submitted
- 25 Mar 2025
- Last updated
- 7 May 2026
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Quality of Patient Experience Via an Innovative Reduction of Pre-Operative Anxiety
- ClinicalTrials.gov ID
- NCT06949943
- Acronym / sponsor ID
- OSU-24146
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 Apr 2025 (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.
This clinical trial tests how well guided meditation, compared to silence, works to reduce pre-operative anxiety in patients undergoing cancer-directed surgery. Pre-operative anxiety affects patient experience and has been found to be a predictor of severe post-operative pain and chronic pain after surgery, influencing the success and quality of a patient's recovery. While medication is often prescribed to improve anxiety symptoms, research has showed that mindfulness techniques can be used to decrease anxiety, improve comfort, and can impact both psychological and physiologic symptoms. Completing pre-operative guided meditation may work well to reduce pre-operative anxiety in patients undergoing cancer directive surgery.
Detailed description
PRIMARY OBJECTIVE:
- To improve is pre-operative patient anxiety in surgical settings.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients listen to 10 minutes of guided meditation prior to surgery.
ARM II: Patients wear noise cancelling headphones for 10 minutes prior to surgery.
After completion of study intervention, patients are followed up for up to 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (guided meditation) | Experimental | Behavioral: Behavioral Intervention, Other: Electronic Health Record Review, Other: Survey AdministrationPatients listen to 10 minutes of guided meditation prior to surgery. |
| Arm II (noise cancelling headphones) | Active comparator | Behavioral: Behavioral Intervention, Other: Electronic Health Record Review, Other: Survey AdministrationPatients wear noise cancelling headphones for 10 minutes prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will be recruited among patients who are scheduled for cancer-directed surgery
- Participants must be 18 years or older
Key exclusion criteria (5 listed)
- Participants will be excluded from the study if they cannot speak English (as the meditation is recorded in English)
- Currently incarcerated
- Have a diagnosis of dementia
- Are admitted to the intensive care unit (ICU)
- Have a hearing impairment that would make them unable to hear the recorded meditation
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 |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyListen to guided meditation | Behavioural | Arm I (guided meditation) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyWear noise cancelling headphones | Behavioural | Arm II (noise cancelling headphones) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (guided meditation), Arm II (noise cancelling headphones) |
| Survey AdministrationAncillary studies | Other | Arm I (guided meditation), Arm II (noise cancelling headphones) |
Primary outcome
Pre-operative anxiety (PROMIS Anxiety scale)
Time frame: Pre and post intervention, approximately 10 minutes
Measured with the Patient Reported Outcome Measurement Information System Anxiety. PROMIS Anxiety short form is an 8-item scale used to assess anxiety in individuals 18 years or older. Each item is on a 5-point scale to be summed, with higher scores indicating greater anxiety.
Pre-operative anxiety (single-item visual analog scale)
Time frame: Pre and post intervention, approximately 10 minutes
Measured by a single-item visual analog scale. The single-item visual analog scale will be used to assess momentary anxiety. The item will ask, "On a scale of 1 to 10, how anxious do you feel right now?" and patients will rate the level of anxiety on a scale of 0 to 10 (0=not at all anxious, 10=extremely anxious).
4 secondary outcomes
Post-operative opiate use
Time frame: Up to 6 months post intervention
Post-operative morphine equivalent dose
Time frame: Up to 6 months post intervention
Post-operative average daily morphine
Time frame: Up to 6 months post intervention
Length of stay
Time frame: Up to 6 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- The JameslineLink provided by the sponsor.
Related trials for Hematopoietic and Lymphatic System Neoplasm
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
The Ohio State University Comprehensive Cancer Center contact
Maryanna Klatt, PhD principal investigator
Ohio State University Comprehensive Cancer 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 Behavioral Intervention, Electronic Health Record Review and Survey Administration in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer 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 2 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative anxiety (PROMIS Anxiety scale) (time frame: Pre and post intervention, approximately 10 minutes). The study lists 2 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 7 May 2026.