- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06322615
Acupressure for Reducing Anxiety in Patients Undergoing Chemotherapy
Acupressure for Anxiety: A Pilot Study of a Nurse-Led Acupressure Intervention for Patients Receiving Chemotherapy
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of a nurse- and patient-applied acupressure intervention for patients with anxiety associated with active cancer-directed therapy.
II. Patient-reported changes in acute anxiety associated with both the nurse and self-led acupressure interventions will be ascertained.
OUTLINE:
Patients undergo acupressure over 15-120 seconds at a time for up to 15 minutes. After completion of the session, patients may optionally receive an education session on using acupressure at home.
After completion of study intervention, patients who opted to receive education about using acupressure at home are followed up at 1 week.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be over 18 years of age
- Be actively undergoing chemotherapy in the Mayo Clinic chemotherapy unit
- Report anxiety as a 1 or higher, on a scale from 0 (no anxiety) to 4 (severe anxiety)
- Be willing to undergo a short acupressure session
Exclusion Criteria:
- Does not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive Care (acupressure)
Patients undergo acupressure over 15-120 seconds at a time for up to 15 minutes.
After completion of the session, patients may optionally receive an education session on using acupressure at home.
|
Ancillary studies
Ancillary studies
Undergo acupressure
Other Names:
Receive education session about using acupressure at home
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients approached about undergoing acupressure intervention (Feasibility)
Time Frame: Up to 1 year
|
Assessed by the number of patients approached about undergoing acupressure intervention.
|
Up to 1 year
|
|
Number of patients interested in the initial acupressure intervention in the chemotherapy unit (Feasibility)
Time Frame: Up to 1 year
|
Assessed by the number of patients who express interest in the initial acupressure intervention in the chemotherapy unit.
|
Up to 1 year
|
|
Number of patients interested in the home acupressure intervention (Feasibility)
Time Frame: Up to 1 year
|
Assessed by the number of patients who express interest in the home acupressure intervention.
|
Up to 1 year
|
|
Time taken for each nurse-led acupressure intervention in the chemotherapy unit (Feasibility)
Time Frame: Up to 1 year
|
Assess by the time recorded for ach nurse-led acupressure intervention in the chemotherapy unit.
|
Up to 1 year
|
|
Patient-reported changes in acute anxiety
Time Frame: At baseline, after a one-time nurse-administered acupressure session, and after one week of self-administered acupressure sessions
|
Assessed with a brief anxiety questionnaire that inquires about the three different domains of anxiety: cognitive symptoms, emotional symptoms, and physical symptoms.
Seven questions are answered using 11-point (0-10) scales with different values assigned to the scale per question (e.g.
0=no anxiety/10=worst possible anxiety or 0=strongly disagree/10=strongly agree).
|
At baseline, after a one-time nurse-administered acupressure session, and after one week of self-administered acupressure sessions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura S. Rhee, D.O., Mayo Clinic in Rochester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Investigative Techniques
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Health Services
- Health Care Facilities Workforce and Services
- Child Health Services
- Community Health Services
- Preventive Health Services
- Socioeconomic Factors
- Population Characteristics
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Methods
- Early Intervention, Educational
- Educational Status
- Acupressure
Other Study ID Numbers
- MC221001 (Other Identifier: Mayo Clinic in Rochester)
- NCI-2024-00538 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 23-004067 (Other Identifier: Mayo Clinic Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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